LIVE WEBINAR: Saturday, October 23, 2021, 9:30 AM – 4:30 PM Eastern Time

Recent Advances and Future Directions in Oncology: A Daylong Multitumor Educational Webinar in Partnership with Florida Cancer Specialists

A CME-MOC/NCPD Accredited Virtual Event

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Join us on Saturday, October 23 for this daylong multitumor CME-MOC/NCPD-accredited live webinar
9:30 AM – 4:30 PM Eastern Time

Faculty

Breast Cancer

Ann Partridge, MD, MPH
Vice Chair of Medical Oncology
Director, Program for Young Women with Breast Cancer
Director, Adult Survivorship Program
Dana-Farber Cancer Institute
Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Mark D Pegram, MD
Susy Yuan-Huey Hung Endowed Professor of Oncology
Director, Clinical and Translational Research Unit
Associate Dean for Clinical Research Quality
Stanford University School of Medicine
Associate Director for Clinical Research
Stanford Comprehensive Cancer Institute
Stanford, California

Lung Cancer

Lecia V Sequist, MD, MPH
Director, Center for Innovation in Early Cancer Detection
Massachusetts General Hospital Cancer Center
The Landry Family Professor of Medicine
Harvard Medical School
Boston, Massachusetts

David R Spigel, MD
Chief Scientific Officer
Thoracic Oncology
Sarah Cannon Research Institute
Nashville, Tennessee

Gastrointestinal Cancers

Tanios Bekaii-Saab, MD
Professor, Mayo Clinic College of Medicine and Science
Program Leader, Gastrointestinal Cancer
Mayo Clinic Cancer Center
Consultant, Mayo Clinic in Arizona
Chair, ACCRU Research Consortium
Phoenix, Arizona

Kristen K Ciombor, MD, MSCI
Assistant Professor of Medicine
Division of Hematology/Oncology
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee

Genitourinary Cancers

Neeraj Agarwal, MD
Professor of Medicine
Senior Director for Clinical Research Innovation
Huntsman Cancer Institute Presidential Endowed Chair of Cancer Research
Director, Center of Investigational Therapeutics
Director, Genitourinary Oncology Program
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah

Daniel P Petrylak, MD
Professor of Internal Medicine (Medical Oncology) and Urology
Yale School of Medicine
New Haven, Connecticut

Chronic Lymphocytic Leukemia and Lymphomas

Brad S Kahl, MD
Professor of Medicine
Washington University School of Medicine
Director, Lymphoma Program
Siteman Cancer Center
St Louis, Missouri

Andrew D Zelenetz, MD, PhD
Medical Director, Quality Informatics
Attending Physician
Memorial Sloan Kettering Cancer Center
Professor of Medicine
Weill Cornell Medical College
New York, New York

Multiple Myeloma

Noopur Raje, MD
Director, Center for Multiple Myeloma
Massachusetts General Hospital Cancer Center
Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Saad Zafar Usmani, MD, MBA
Chief of Myeloma Service (starting 11/1/2021)
Memorial Sloan Kettering Cancer Center
Professor of Medicine
Weill Cornell Medical College
New York, New York

Acute Myeloid Leukemia and Myelodysplastic Syndromes

Mark Levis, MD, PhD
Professor of Oncology
Co-Division Director, Hematologic Malignancies
The Sidney Kimmel Comprehensive Cancer Center
Johns Hopkins University
Baltimore, Maryland

David Sallman, MD
Assistant Member
Malignant Hematology
Moffitt Cancer Center
Tampa, Florida

Moderator
Neil Love, MD
Research To Practice
Miami, Florida


This activity is supported by educational grants from Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo Inc, Eisai Inc, Exact Sciences Inc, G1 Therapeutics Inc, Genentech, a member of the Roche Group, Incyte Corporation, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Merck, Natera Inc, Novartis, Oncopeptides, Pharmacyclics LLC, an AbbVie Company and Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc and Sanofi Genzyme, Sanofi Genzyme, Seagen Inc, Taiho Oncology Inc, and Takeda Pharmaceuticals USA Inc.

CME-MOC/NCPD-accredited LIVE Webinar
Saturday, October 23, 2021
9:30 AM – 4:30 PM Eastern Time

Schedule Subject To Change

Breast Cancer | 9:30 AM – 10:20 AM ET

PART I: EARLY-STAGE BREAST CANCER

HER2-Positive Disease

  • Key clinical factors affecting the decision to administer neoadjuvant systemic treatment for patients with HER2-positive localized breast cancer; selection of an appropriate neoadjuvant regimen
  • Available data exploring the feasibility of chemotherapy de-escalation in the setting of dual HER2 blockade for patients with early-stage disease
  • Clinical implications of the FDA approval of adjuvant T-DM1 for patients with residual disease after neoadjuvant therapy
  • Long-term efficacy and safety findings with pertuzumab as a component of adjuvant treatment for HER2-positive localized breast cancer
  • Patient selection for and clinical factors guiding the use of neratinib as extended adjuvant therapy; improvement in rates of CNS recurrence observed in long-term follow-up of the Phase III ExteNET study
  • Ongoing clinical trials investigating novel HER2-targeted strategies for HER2-positive localized breast cancer (eg, DESTINY-Breast05, CompassHER2 RD, MARGOT)

ER-Positive Disease

  • Design, eligibility criteria and major findings from the Phase III RxPONDER trial evaluating the role of chemotherapy for patients with ER-positive, HER2-negative early breast cancer with 1 to 3 positive lymph nodes and a 21-gene Recurrence Score® of ≤25
  • Benefit associated with chemotherapy for premenopausal versus postmenopausal patients in the RxPONDER trial; implications for practice
  • Other recent clinical trial findings informing the use of genomic assays to guide neoadjuvant and adjuvant treatment decision-making (eg, ADAPT)
  • Key efficacy and safety outcomes observed with the addition of abemaciclib to standard adjuvant hormonal therapy for patients with ER-positive, HER2-negative breast cancer at high risk for recurrence in the Phase III monarchE trial
  • Other ongoing clinical research evaluating CDK4/6 inhibitors as neoadjuvant or adjuvant therapy

Triple-Negative Disease

  • Design, eligibility criteria and primary and secondary endpoints of the Phase III OlympiA trial assessing adjuvant olaparib versus placebo for patients with germline BRCA1/2 mutations and high-risk HER2-negative breast cancer
  • Key efficacy and safety outcomes from the OlympiA trial; current and potential role of adjuvant olaparib
  • Available data from the Phase III KEYNOTE-522 study demonstrating an event-free survival advantage with neoadjuvant pembrolizumab combined with chemotherapy and continued as a single agent after surgery for high-risk early-stage triple-negative breast cancer (TNBC); FDA approval and current role in practice
  • Other ongoing clinical research evaluating PARP inhibitors or immune checkpoint inhibitors as a component of neoadjuvant and/or adjuvant therapy

PART II: METASTATIC BREAST CANCER

HER2-Positive Disease

  • Published efficacy and safety data from the pivotal HER2CLIMB, DESTINY-Breast01 and NALA studies of tucatinib/trastuzumab/capecitabine, trastuzumab deruxtecan (T-DXd) and neratinib/capecitabine, respectively, for patients with HER2-positive metastatic breast cancer (mBC)
  • Mechanism of action of margetuximab; key efficacy and safety findings from the Phase III SOPHIA trial evaluating margetuximab/chemotherapy versus trastuzumab/chemotherapy for patients with multiregimen-relapsed HER2-positive mBC
  • Optimal integration of tucatinib/trastuzumab/capecitabine, T-DXd, neratinib/capecitabine and margetuximab/chemotherapy into therapy for patients with and without brain metastases
  • Design, eligibility criteria and emerging efficacy and safety data from the Phase III DESTINY-Breast03 trial evaluating T-DXd versus T-DM1 for patients with HER2-positive mBC previously treated with trastuzumab and a taxane
  • Biologic rationale for, early data with and ongoing evaluation of T-DXd for patients with HER2-low breast cancer
  • Emerging results from the Phase III TULIP study demonstrating improved progression-free survival with the antibody-drug conjugate trastuzumab duocarmazine compared to physician’s choice of therapy for pretreated HER2-positive mBC
  • Ongoing clinical studies (eg, HER2CLIMB-02, DESTINY-Breast07) evaluating novel HER2-targeted combination strategies for HER2-positive mBC; estimated completion dates

ER-Positive Disease

  • Long-term follow-up data, including overall survival findings, with CDK4/6 inhibitors for ER-positive mBC; factors in the selection of a CDK4/6 inhibitor and an endocrine partner
  • Incidence, monitoring and management of commonly occurring class- and agent-specific toxicities associated with CDK4/6 inhibition
  • Proposed mechanisms of resistance to CDK4/6 inhibition; incidence, identification and prognostic significance of PIK3CA mutations in patients with ER-positive mBC
  • Major research findings with alpelisib/fulvestrant for patients with ER-positive mBC with a PIK3CA mutation
  • Spectrum, frequency and severity of alpelisib-related toxicities; optimal prevention and management strategies
  • Other novel agents and strategies under investigation for ER-positive mBC (eg, patritumab deruxtecan, capivasertib, sacituzumab govitecan, SERDs, FGFR inhibitors)

Triple-Negative Disease

  • FDA approvals of atezolizumab/nab paclitaxel and pembrolizumab/chemotherapy for patients with previously untreated PD-L1-positive metastatic TNBC; optimal integration into practice
  • Key clinical research findings guiding the optimal use of PARP inhibitors for patients with mBC
  • Key efficacy and safety findings from the Phase III ASCENT trial comparing sacituzumab govitecan to physician’s choice of chemotherapy for relapsed/refractory TNBC; FDA approval and optimal integration of sacituzumab govitecan into clinical practice
  • Other novel agents under investigation for patients with metastatic TNBC (eg, T-DXd, ladiratuzumab vedotin, datopotamab deruxtecan)

PROGRAM BREAK | 10:20 AM – 10:30 AM ET

Lung Cancer | 10:30 AM – 11:20 AM ET

PART I: TARGETED THERAPIES FOR NON-SMALL CELL LUNG CANCER (NSCLC)

Localized and Metastatic NSCLC with EGFR Mutation

  • Key efficacy and safety findings, including rates of CNS disease recurrence, from the Phase III ADAURA trial evaluating adjuvant osimertinib versus placebo after complete tumor resection for early-stage NSCLC with EGFR mutation
  • Recent FDA approval of adjuvant osimertinib; patient selection and optimal incorporation into clinical care
  • Optimal first-line treatment for patients with metastatic NSCLC with EGFR tumor mutations; overall and progression-free survival benefit observed with up-front osimertinib
  • FDA approval of and patient selection for erlotinib/bevacizumab as first-line therapy
  • Incidence, clinical relevance and spectrum of resistance mechanisms in patients experiencing disease progression on osimertinib
  • Mechanism of action, available data and ongoing research with the novel HER3-directed antibody-drug conjugate patritumab deruxtecan for metastatic NSCLC resistant to EGFR tyrosine kinase inhibition
  • Available efficacy and safety findings from the CHRYSALIS study supporting the recent FDA approval of amivantamab for patients with metastatic NSCLC and EGFR exon 20 mutations; optimal incorporation into practice

Metastatic NSCLC with ALK and ROS1 Rearrangements

  • Optimal selection of first- and later-line therapy for patients with metastatic NSCLC with an ALK rearrangement
  • Available data informing the use of alectinib, brigatinib and lorlatinib as first-line therapy for patients with ALK-rearranged NSCLC
  • Key factors in the selection of therapy for patients with progressive NSCLC with an ALK rearrangement; role and implications of repeat biomarker testing and implications for decision-making
  • Principal findings demonstrating the efficacy and safety of entrectinib for NSCLC with a ROS1 rearrangement; appropriate integration into clinical practice
  • Intracranial response rates observed with entrectinib in patients with ROS1-rearranged NSCLC and CNS involvement; implications for clinical care
  • Published data with, ongoing trials of and plans to develop other “next-generation” ROS1 inhibitors (eg, repotrectinib, larotrectinib, lorlatinib, ceritinib)

Metastatic NSCLC with Genomic Aberrations Beyond EGFR, ALK and ROS1

  • Frequency of other targetable mutations (eg, RET, MET exon 14, HER2, KRAS) in metastatic NSCLC; optimal testing protocols
  • Reported activity and safety data with selpercatinib and pralsetinib for patients with advanced NSCLC and RET alterations; optimal integration into clinical practice
  • Published research findings with and current roles of capmatinib and tepotinib in therapy for patients with NSCLC with MET exon 14 mutations
  • Key efficacy and safety outcomes from the Phase II DESTINY-Lung01 study evaluating trastuzumab deruxtecan for NSCLC with HER2 mutation; FDA breakthrough therapy designation, ongoing evaluation and potential nonresearch role
  • Principal efficacy and safety findings with sotorasib for pretreated NSCLC with KRAS G12C mutation in the Phase II CodeBreaK 100 trial; recent FDA approval and current role in routine practice

PART II: IMMUNOTHERAPY AND OTHER NONTARGETED APPROACHES FOR PATIENTS WITH LUNG CANCER

Small Cell Lung Cancer (SCLC)

  • Key efficacy and safety findings with atezolizumab or durvalumab in combination with chemotherapy for patients with previously untreated extensive-stage SCLC
  • Appropriate integration of first-line carboplatin/etoposide/atezolizumab and platinum/etoposide/durvalumab into SCLC management
  • Other immune checkpoint inhibitor-based strategies under evaluation for patients with extensive- or limited-stage SCLC
  • Available and emerging data with and current clinical role of lurbinectedin for patients with SCLC that has progressed after prior platinum-based therapy
  • Efficacy and safety results from randomized studies evaluating trilaciclib as a means to preserve bone marrow function during chemotherapy in patients with extensive-stage SCLC; recent FDA approval and optimal incorporation into routine practice

Localized and Locally Advanced NSCLC

  • Available efficacy findings from the Phase III CheckMate 816 trial evaluating nivolumab in combination with chemotherapy as neoadjuvant therapy for patients with resectable NSCLC; implications for ongoing research and clinical practice
  • Key outcomes from the Phase III IMpower010 trial evaluating atezolizumab versus best supportive care after adjuvant chemotherapy for patients with completely resected NSCLC; current nonresearch and potential role of adjuvant atezolizumab
  • Long-term efficacy and safety findings, including 5-year overall survival data, from the Phase III PACIFIC trial evaluating consolidation durvalumab after chemoradiation therapy for patients with unresectable Stage III NSCLC
  • Patient selection for and practical implementation of consolidation durvalumab
  • Other ongoing and planned clinical trials of immune checkpoint inhibitors for patients with nonmetastatic NSCLC

Metastatic NSCLC

  • Clinical trial database supporting the FDA approvals of pembrolizumab and atezolizumab administered as monotherapy or combined with chemotherapy as first-line treatment for metastatic NSCLC
  • Available efficacy and safety data from the Phase III EMPOWER-Lung 1 trial of first-line cemiplimab monotherapy for patients with NSCLC with PD-L1 in ≥50% of tumor cells; recent FDA approval and current clinical role
  • Phase III clinical trial results (CheckMate 227, CheckMate 9LA) with first-line nivolumab/ipilimumab with and without chemotherapy; patient selection for this combination and optimal integration into practice
  • Emerging results from the Phase III EMPOWER-Lung 3 study demonstrating an overall survival advantage with cemiplimab in combination with platinum-based chemotherapy as first-line therapy for NSCLC
  • Clinical and biologic factors in selecting among anti-PD-1/PD-L1 monotherapy, combined chemoimmunotherapy and dual immune checkpoint inhibition for patients with nonsquamous and squamous metastatic NSCLC
  • Design, eligibility criteria and emerging results from the Phase III POSEIDON trial evaluating the addition of durvalumab or durvalumab and tremelimumab to chemotherapy as first-line therapy for patients with metastatic NSCLC
  • Efficacy and safety observed with the anti-TIGIT monoclonal antibody tiragolumab in combination with atezolizumab in patients with PD-L1-positive metastatic NSCLC; FDA breakthrough therapy designation and development plans
  • Management of disease that has progressed on anti-PD-1/PD-L1-based therapy in the first-line setting; current role of approved agents and regimens (eg, ramucirumab, afatinib, bevacizumab)
  • Biologic rationale for targeting Trop-2 in lung cancer; mechanism of action and ongoing investigation of the Trop-2-directed antibody-drug conjugate datopotamab deruxtecan for patients with progressive metastatic NSCLC

PROGRAM BREAK | 11:20 AM – 11:30 AM ET

Gastrointestinal Cancers | 11:30 AM – 12:20 PM ET

PART I: COLORECTAL AND GASTROESOPHAGEAL CANCER

Colorectal Cancer (CRC)

  • Indications for molecular testing in patients with metastatic CRC (mCRC)
  • Available data linking tumor sidedness and response to specific therapeutic interventions in patients with mCRC
  • Appropriate integration of encorafenib/cetuximab for patients with mCRC and BRAF V600E mutations; available results and ongoing evaluation with earlier use of BRAF-targeted therapy
  • Rational incorporation of pembrolizumab, nivolumab and nivolumab/ipilimumab into the treatment of microsatellite instability (MSI)-high/mismatch repair-deficient (dMMR) mCRC
  • Ongoing investigation of immune checkpoint inhibitors in combination with other systemic approaches (eg, chemotherapy, targeted therapy) for MSI-high/dMMR and microsatellite-stable mCRC
  • Updated efficacy findings from the Phase II DESTINY-CRC01 study of trastuzumab deruxtecan (T-DXd) for patients with HER2-expressing mCRC; ongoing evaluation and potential nonresearch role
  • Early results with and ongoing evaluation of the KRAS G12C inhibitor sotorasib for mCRC with KRAS p.G12C mutation
  • Rational incorporation of regorafenib and TAS-102 into treatment algorithms for patients with multiregimen-relapsed mCRC
  • Available data with and potential role of TAS-102 in combination with other systemic agents for metastatic and earlier-stage CRC
  • Other promising agents and strategies under investigation for CRC

Gastroesophageal Cancer

  • Phase III trial results (eg, KEYNOTE-590, CheckMate 649, CheckMate 648) supporting the efficacy and safety of first-line regimens combining chemotherapy and immunotherapy for advanced gastric, gastroesophageal junction (GEJ) and esophageal cancers
  • Available efficacy and safety outcomes from the Phase III CheckMate 577 study of adjuvant nivolumab for patients with resected esophageal or GEJ cancer; recent FDA approval and appropriate integration into practice
  • Optimal placement of ramucirumab in current clinical algorithms for metastatic gastric/GEJ cancer; ongoing investigation of ramucirumab-containing combination regimens
  • Clinical research supporting the use of TAS-102 for heavily pretreated metastatic gastric/GEJ cancer; patient selection for and ongoing research with TAS-102
  • Frequency of HER2 amplification in advanced gastric/GEJ cancer; management of HER2-positive disease in the newly diagnosed and relapsed/refractory settings
  • Principal outcomes from the Phase III KEYNOTE-811 trial supporting the FDA approval of first-line pembrolizumab/trastuzumab/chemotherapy for metastatic HER2-positive gastric/GEJ adenocarcinoma
  • Updated efficacy results from the Phase II DESTINY-Gastric01 study of T-DXd for patients with progressive HER2-positive gastric/GEJ cancer; optimal incorporation into routine practice; ongoing studies in earlier lines of treatment
  • Frequency of FGFR2b overexpression in gastroesophageal cancers; mechanism of action of bemarituzumab
  • Major efficacy and safety data from the Phase II FIGHT trial evaluating bemarituzumab/chemotherapy versus chemotherapy alone as first-line therapy for patients with FGFR2b-positive metastatic gastric/GEJ cancer
  • Other promising agents and strategies under investigation for gastroesophageal cancers

PART II: HEPATOBILIARY AND PANCREATIC CANCER

Hepatocellular Carcinoma (HCC)

  • Clinical and biologic factors in the selection of first-line treatment for advanced HCC (eg, patient age, symptomatology, liver function)
  • Key efficacy and safety findings supporting the use of first-line atezolizumab/bevacizumab for unresectable HCC; optimal integration into routine practice
  • Available data with and current clinical roles of sorafenib and lenvatinib as first-line therapy for unresectable HCC; patient selection for tyrosine kinase inhibitor (TKI) monotherapy
  • Emerging results from the Phase III COSMIC-312 study demonstrating a progression-free survival advantage but no statistically significant overall survival advantage with first-line cabozantinib/atezolizumab compared to sorafenib monotherapy
  • Primary findings with and ongoing evaluation of other immune checkpoint inhibitor/TKI combination strategies for newly diagnosed and previously treated advanced HCC
  • Key factors in the selection and sequencing of approved regimens for patients whose disease has progressed on first-line therapy
  • Long-term outcomes with approved anti-angiogenic agents (eg, regorafenib, cabozantinib, ramucirumab) for patients with progressive HCC
  • Published efficacy and safety data with the use of anti-PD-1/PD-L1 antibodies alone or in combination with anti-CTLA antibodies for patients with relapsed HCC
  • Other promising agents and strategies currently under investigation for HCC

Cholangiocarcinoma and Biliary Tract Cancer

  • Spectrum of molecular alterations in cholangiocarcinoma; utility of genomic analyses to identify actionable molecular abnormalities
  • Principle efficacy and safety findings supporting the FDA approvals of pemigatinib and infigratinib for patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement
  • Efficacy and safety outcomes observed with futibatinib in patients with intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements in the Phase II FOENIX-CCA2 study
  • Ongoing trials evaluating FGFR inhibition for patients with treatment-naïve cholangiocarcinoma (eg, FIGHT-302, PROOF, FOENIX-CCA3)
  • Outcomes from the Phase III ClarIDHy study evaluating the IDH1 inhibitor ivosidenib for patients with previously treated cholangiocarcinoma with an IDH1 mutation; implications for current practice and future research
  • Recently presented findings evaluating the addition of liposomal irinotecan (nal-IRI) to 5-FU/LV for patients with progressive metastatic biliary tract cancer
  • Early results with and ongoing evaluation of immune checkpoint inhibitors in combination with other systemic therapies (eg, chemotherapy, lenvatinib, regorafenib) for biliary tract cancer

Pancreatic Cancer

  • Clinical trials evaluating preoperative chemotherapy with or without radiation therapy for patients with resectable or borderline-resectable pancreatic adenocarcinoma (PAD); role of contemporary cytotoxic regimens (modified FOLFIRINOX, nab paclitaxel/gemcitabine) in this setting
  • Selection of adjuvant systemic therapy for patients with resected PAD; recently presented overall survival findings from the Phase III APACT trial evaluating adjuvant nab paclitaxel/gemcitabine and the implications, if any, for clinical practice
  • Optimal selection of first- and later-line treatment for patients with metastatic PAD; importance of age, comorbidities and prior therapy
  • Early front-line activity observed with the combination of nal-IRI, 5-FU/leucovorin and oxaliplatin (NALIRIFOX) in patients with metastatic PAD
  • Patient selection for and practical integration of nal-IRI for relapsed metastatic PAD
  • Incidence of BRCA1/2 mutations and other DNA damage response abnormalities in patients with PAD; guideline-endorsed algorithms for genetic testing
  • Key efficacy and safety findings with and optimal integration of olaparib as maintenance therapy after first-line chemotherapy for patients with metastatic PAD and a germline BRCA mutation
  • Biologic rationale for the investigation of PARP inhibitors combined with other anticancer therapies (ie, chemotherapy, anti-PD-1/PD-L1 antibodies) in metastatic PAD
  • Other novel agents and strategies (eg, zenocutuzumab, immune checkpoint inhibitors) under investigation for PAD

PROGRAM BREAK | 12:20 PM – 12:30 PM ET

Genitourinary Cancers | 12:30 PM – 1:20 PM ET

PART I: PROSTATE CANCER

Nonmetastatic and Hormone-Sensitive Metastatic Prostate Cancer

  • Major efficacy and safety findings with and current clinical role of the oral GnRH antagonist relugolix for men with advanced prostate cancer
  • PSA level, PSA doubling time, disease-free interval and other factors in the decision to initiate androgen deprivation therapy (ADT) in combination with secondary hormonal therapy for PSA-only relapse in men with nonmetastatic castration-resistant prostate cancer (CRPC)
  • Key efficacy outcomes with enzalutamide, apalutamide and darolutamide for nonmetastatic CRPC; implications of differential toxicity profiles for selection of therapy
  • Rationale for the evaluation of secondary hormonal agents in patients with nonmetastatic castration-sensitive disease; ongoing and planned Phase III trials
  • Long-term efficacy and safety data with docetaxel, abiraterone, enzalutamide or apalutamide in combination with ADT for patients with metastatic hormone-sensitive prostate cancer (mHSPC); clinical and biologic factors in selecting among these agents
  • Recently reported results from the Phase III PEACE-1 study of docetaxel with or without abiraterone with or without local radiation therapy for men with de novo mHSPC; implications for clinical practice
  • Design, eligibility criteria and key endpoints of Phase III trials (eg, ARASENS, ARANOTE) assessing darolutamide-based therapy for men with mHSPC

Metastatic CRPC (mCRPC)

  • Considerations in the selection and sequencing of therapy for patients with mCRPC; impact of earlier use of chemotherapy and secondary hormonal therapy
  • Incidence of BRCA1/2 and other homologous recombination repair abnormalities in patients with prostate cancer; indications for and practical implementation of genetic testing
  • Key efficacy and safety data with the approved PARP inhibitors olaparib and rucaparib for men with mCRPC; optimal integration into management algorithms
  • Ongoing research with PARP inhibitors alone or in combination with androgen receptor-targeted agents or immune checkpoint inhibitors for mCRPC
  • Available research findings (eg, from the CARD and OSTRICh trials) supporting the use of cabazitaxel for patients with mCRPC
  • Patient selection for radium-223 and optimal integration into mCRPC treatment algorithms
  • Effects of adding bone-protecting agents during treatment with radium-223/enzalutamide in the Phase III EORTC-1333-GUCG/PEACE III trial and implications for current practice and future research
  • Mechanism of action of the novel radioligand therapy 177Lu-PSMA-617; key efficacy and safety findings from the Phase III VISION study for patients with progressive PSMA-positive mCRPC
  • Frequency of PTEN loss in mCRPC; key efficacy and safety data with ipatasertib in combination with abiraterone/prednisone for patients with mCRPC and PTEN loss
  • Preliminary findings with and ongoing evaluation of cabozantinib in combination with atezolizumab for mCRPC
  • Other novel agents and strategies under investigation for mCRPC

PART II: RENAL CELL CARCINOMA AND UROTHELIAL BLADDER CANCER

Renal Cell Carcinoma (RCC)

  • Key efficacy and safety findings from the Phase III KEYNOTE-564 study of adjuvant pembrolizumab for high-risk clear-cell RCC; implications for clinical practice
  • Long-term findings with nivolumab/ipilimumab, pembrolizumab/axitinib and avelumab/axitinib for treatment-naïve metastatic RCC (mRCC)
  • Major efficacy and safety data from the Phase III CheckMate 9ER trial evaluating nivolumab in combination with cabozantinib for previously untreated mRCC; FDA approval and optimal integration into current first-line treatment algorithms
  • Principal findings from the Phase III KEYNOTE-581/CLEAR trial comparing lenvatinib/pembrolizumab or lenvatinib/everolimus to sunitinib as first-line therapy for mRCC; FDA approval of lenvatinib/pembrolizumab
  • Available data with and ongoing evaluation of other novel combination strategies for previously untreated advanced RCC
  • Rational sequencing of available therapies for RCC progressing on front-line treatment; patient-specific factors in decision-making
  • Research database supporting the use of cabozantinib for patients with relapsed/refractory RCC
  • Published data with and optimal incorporation of other tyrosine kinase inhibitors (eg, lenvatinib, axitinib, tivozanib) in therapy for progressive mRCC
  • Role of rechallenging with alternative checkpoint inhibitor-based approaches for patients who have experienced disease progression on immunotherapy
  • Clinical trial findings (eg, SWOG-S1500/PAPMET) informing the selection of therapy for patients with papillary RCC
  • Mechanism of action, available data, FDA approval and ongoing evaluation of belzutifan for patients with von Hippel-Lindau disease-associated RCC
  • Other novel agents and strategies with promising activity in RCC; key ongoing research

Urothelial Bladder Cancer (UBC)

  • Selection of appropriate patients with high-risk non-muscle-invasive bladder cancer for pembrolizumab therapy
  • Key efficacy and safety data from the Phase III CheckMate 274 trial comparing nivolumab to placebo after surgery for patients with high-risk muscle-invasive bladder cancer
  • Ongoing research evaluating anti-PD-1/PD-L1 antibodies for patients with non-muscle-invasive or muscle-invasive bladder cancer
  • Current clinical role of atezolizumab and pembrolizumab as first-line treatment for metastatic UBC (mUBC); importance of chemotherapy eligibility and PD-L1 status in patient selection for this strategy
  • Key efficacy and safety data with maintenance avelumab after front-line chemotherapy for patients with mUBC; incorporation into clinical care
  • Principal findings with and ongoing trials evaluating anti-PD-1/PD-L1 antibodies in combination with other systemic therapies (eg, chemotherapy, anti-CTLA-4 antibodies) for mUBC
  • Published efficacy and safety findings with enfortumab vedotin for patients with progressive mUBC; FDA-approved indication and optimal integration into the current treatment paradigm
  • Key findings with and potential clinical role of enfortumab vedotin in combination with pembrolizumab for patients with previously untreated mUBC
  • Spectrum and frequency of FGFR genetic alterations in patients with mUBC; published efficacy and safety data and current clinical role of erdafitinib in therapy for mUBC with susceptible FGFR3 or FGFR2 alterations
  • Frequency of Trop-2 expression in UBC; mechanism of action of sacituzumab govitecan
  • Design, eligibility criteria and key efficacy and safety findings from the Phase II TROPHY U-01 trial leading to the recent FDA approval of sacituzumab govitecan for progressive mUBC; optimal integration into clinical management
  • Frequency of HER2 expression in mUBC; FDA breakthrough therapy designation for disitamab vedotin as second-line therapy for HER2-positive bladder cancer
  • Other promising agents and strategies in UBC (eg, futibatinib, infigratinib, cabozantinib)

PROGRAM BREAK | 1:20 PM – 1:30 PM ET

Chronic Lymphocytic Leukemia and Lymphomas | 1:30 PM – 2:20 PM ET

PART I: CHRONIC LYMPHOCYTIC LEUKEMIA AND FOLLICULAR LYMPHOMA

Chronic Lymphocytic Leukemia (CLL)

  • Pivotal data sets informing the use of Bruton tyrosine kinase (BTK) inhibitor-based therapy for patients with treatment-naïve CLL
  • Implications for therapeutic decision-making of results from the Phase III ELEVATE-RR study of acalabrutinib versus ibrutinib for patients with previously treated high-risk CLL
  • Available data with zanubrutinib for CLL, including recently presented results from the Phase III ALPINE study
  • Emerging results from the Phase III SEQUOIA trial comparing zanubrutinib to bendamustine with rituximab for patients with treatment-naïve CLL
  • Key data sets informing the optimal use of venetoclax for patients with newly diagnosed or relapsed/refractory (R/R) CLL
  • Current clinical role of PI3K inhibition in the treatment of CLL
  • Unique mechanism of action of the PI3K-delta inhibitor umbralisib; efficacy and safety in combination with the anti-CD20 antibody ublituximab in the Phase III UNITY-CLL study
  • Similarities and differences between covalent and investigational noncovalent BTK inhibitors (eg, pirtobrutinib, ARQ 531); efficacy and safety of pirtobrutinib in the Phase I/II BRUIN study, ongoing investigation and potential clinical role
  • Mechanistic rationale for combining BTK inhibitors, Bcl-2 inhibitors and/or anti-CD20 antibodies in the management of CLL; early efficacy and safety outcomes
  • Design, eligibility criteria and major efficacy and safety findings from the Phase III GLOW trial evaluating ibrutinib in combination with venetoclax versus chlorambucil/obinutuzumab for the first-line treatment of CLL; implications for clinical practice
  • Biologic rationale for, available data with and ongoing evaluation of CD19-directed chimeric antigen receptor (CAR) T-cell therapy for patients with R/R CLL

Follicular Lymphoma (FL)

  • Integration of obinutuzumab into current algorithms for treatment-naïve and R/R FL
  • Optimal integration of lenalidomide/rituximab into the management of newly diagnosed and R/R FL
  • Similarities and differences between FDA-approved PI3 kinase inhibitors; implications for clinical use
  • Design, eligibility criteria and key efficacy and safety findings from the Phase III CHRONOS-3 trial evaluating copanlisib in combination with rituximab for patients with R/R FL
  • Available findings from the Phase IIb UNITY-NHL trial evaluating umbralisib for patients with R/R FL, marginal zone lymphoma and small lymphocytic lymphoma; FDA approval of umbralisib
  • Recent FDA approval and current clinical role of tazemetostat for patients with and without EZH2 mutations
  • Available data with and FDA approval of axicabtagene ciloleucel (axi-cel) for R/R FL; identification of patients appropriate for treatment with this agent
  • Published efficacy and safety findings with, FDA regenerative medicine advanced therapy designation for and potential clinical role of tisagenlecleucel (tis-cel) in FL treatment
  • Biologic rationale for, available data with and ongoing evaluation of bispecific antibody therapy; FDA breakthrough therapy designation for mosunetuzumab for R/R FL

PART II: DIFFUSE LARGE B-CELL LYMPHOMA, MANTLE CELL LYMPHOMA AND HODGKIN LYMPHOMA

Diffuse Large B-Cell Lymphoma (DLBCL)

  • Long-term data with axi-cel, tis-cel and lisocabtagene maraleucel (liso-cel) for R/R DLBCL; recent FDA approval of liso-cel and optimal integration into current patient care opposite other available CAR T-cell platforms
  • Emerging results from Phase III studies demonstrating benefit with axi-cel or liso-cel as second-line therapy for large B-cell lymphoma
  • Patient selection and appropriate referral for consideration of CAR T-cell therapy
  • Available efficacy and safety data with polatuzumab vedotin in combination with bendamustine with rituximab for patients with R/R DLBCL; optimal incorporation into management algorithms
  • Design, eligibility criteria and emerging efficacy and safety findings from the Phase III POLARIX trial comparing R-CHOP to polatuzumab, each in combination with R-CHP, for patients with newly diagnosed DLBCL
  • FDA approval and patient selection for tafasitamab/lenalidomide for R/R DLBCL
  • Patient selection, practical implementation and optimal sequencing for selinexor
  • Mechanism of action, available data and recent FDA approval for loncastuximab tesirine; current role in clinical practice
  • Early data with and ongoing and planned evaluation of novel agents (eg, tafasitamab, selinexor) in earlier lines of therapy and/or as part of novel combination strategies for DLBCL

Mantle Cell Lymphoma (MCL)

  • Research database supporting the FDA approvals of ibrutinib, acalabrutinib and zanubrutinib for R/R MCL; key factors in the choice of BTK inhibitor and practical application
  • Activity and safety data with and ongoing Phase III investigations of novel agents (eg, lenalidomide, BTK inhibitors) for previously untreated MCL
  • Available data with, current clinical role of and ongoing trials assessing venetoclax alone or combined with other agents (eg, BTK inhibitors) for patients with MCL
  • FDA approval of brexucabtagene autoleucel and optimal integration into MCL treatment algorithms
  • Efficacy and safety observed with pirtobrutinib in patients with MCL in the Phase I/II BRUIN trial

Hodgkin Lymphoma (HL)

  • Role of brentuximab vedotin (BV) in combination with AVD (doxorubicin/vinblastine/dacarbazine) as first-line therapy for advanced classical HL
  • Available data with and current role of BV for older patients with newly diagnosed HL
  • Potential role of BV alone or in combination with immune checkpoint inhibition as a bridge to transplant for patients experiencing disease progression on up-front treatment
  • Published efficacy and safety findings with anti-PD-1/PD-L1 antibodies alone or in combination with other systemic approaches for patients with HL; current clinical role and ongoing evaluation

PROGRAM BREAK | 2:20 PM – 2:30 PM ET

Multiple Myeloma | 2:30 PM – 3:20 PM ET

PART I: CURRENTLY AVAILABLE THERAPIES FOR MULTIPLE MYELOMA (MM)

Management of Newly Diagnosed MM

  • Published research findings with daratumumab-containing front-line regimens for newly diagnosed MM; role for patients who are eligible and ineligible for transplant
  • Updated data from the Phase II GRIFFIN study evaluating lenalidomide/bortezomib/dexamethasone (RVD) with daratumumab for transplant-eligible patients with newly diagnosed MM; recent NCCN guideline inclusion, current nonresearch role and ongoing investigation of RVD/daratumumab
  • Current utility of carfilzomib as a component of up-front therapy; implications of published research evaluating carfilzomib-based induction therapy
  • Correlation between minimal residual disease (MRD) negativity and long-term outcomes with active treatment for patients with newly diagnosed MM; role of MRD assessment in therapeutic decision-making
  • Selection of an optimal maintenance approach for transplant-eligible and ineligible patients, including those who receive daratumumab-based front-line regimens
  • Available efficacy and safety outcomes with and current indications, if any, for ixazomib as maintenance therapy

Management of Relapsed/Refractory (R/R) MM

  • Published Phase III research with isatuximab for R/R MM (eg, ICARIA-MM, IKEMA trials); optimal use in clinical practice
  • Key findings supporting the FDA approval of selinexor/dexamethasone and selinexor/bortezomib/dexamethasone for patients with R/R MM; ongoing investigation of other selinexor combinations
  • Principal findings with the BCMA-directed antibody-drug conjugate belantamab mafodotin alone and in combination with other systemic therapies for R/R MM; ongoing evaluation and incorporation into routine practice
  • Key efficacy and safety data leading to the FDA approval of melflufen/dexamethasone for patients who have received at least 4 prior lines of therapy; emerging results from the Phase III OCEAN trial and implications of the recent FDA safety warning

PART II: CHIMERIC ANTIGEN RECEPTOR (CAR) T-CELL THERAPY; INVESTIGATIONAL AGENTS AND STRATEGIES

CAR T-Cell Therapy

  • Design, eligibility criteria and updated efficacy and safety results from the pivotal Phase II KarMMa trial evaluating idecabtagene vicleucel (ide-cel) for patients with R/R MM
  • Recent FDA approval of ide-cel for heavily pretreated MM; patient selection and optimal timing
  • Updated findings from the CARTITUDE-1 study of ciltacabtagene autoleucel (cilta-cel) for heavily pretreated MM; potential clinical role
  • Initial results from Cohort A of the CARTITUDE-2 trial investigating cilta-cel after 1 to 3 prior lines of therapy; implications for future research
  • Early data with and ongoing research evaluating other CAR T-cell platforms for MM
  • Incidence and severity of class-effect toxicities observed with BCMA-targeted CAR T-cell therapy

Investigational Agents and Strategies

  • Biologic rationale for targeting Bcl-2 in MM; favorable risk-benefit ratio associated with venetoclax-based therapy for patients with t(11;14) or Bcl-2 overexpression and current nonresearch role, if any, in these populations
  • Ongoing studies (eg, CANOVA) assessing venetoclax-based combination therapy for patients with R/R MM; anticipated completion dates
  • Similarities and differences between CELMoDs (eg, iberdomide, CC-92480) and standard IMiDs; activity and safety observed in patients with heavily pretreated MM
  • Mechanism of action of and available safety and efficacy data with bispecific antibodies (eg, teclistamab, talquetamab, cevostamab, elranatamab) for R/R MM; development plans
  • Other promising novel strategies in clinical development for patients with MM

PROGRAM BREAK | 3:20 PM – 3:30 PM ET

Acute Myeloid Leukemia and Myelodysplastic Syndromes | 3:30 PM – 4:20 PM ET

PART I: ACUTE MYELOID LEUKEMIA (AML)

Management of AML without Targetable Mutations

  • Published data supporting the FDA approval of venetoclax in combination with azacitidine, decitabine or low-dose cytarabine (LDC) for patients with newly diagnosed AML aged 75 or older or those who are not candidates for intensive induction chemotherapy
  • Design, eligibility criteria and key efficacy and safety findings from the Phase III VIALE-A and VIALE-C trials evaluating venetoclax in combination with azacitidine or LDC, respectively, as first-line treatment for patients with AML who are ineligible for intensive chemotherapy
  • Incidence of tumor lysis syndrome and other adverse events associated with venetoclax in AML clinical trials; implications for the implementation of prophylactic measures in routine practice
  • Historical outcomes with intensive induction chemotherapy for patients with AML and unfavorable prognostic features (eg, complex karyotype, TP53 mutation)
  • Early findings with and ongoing investigation of venetoclax for younger, fit patients with newly diagnosed AML
  • Pharmacologic differences between CC-486 and injectable azacitidine; effects on activity and tolerability
  • Efficacy and safety outcomes from the QUAZAR AML-001 study supporting the FDA approval of CC-486 as maintenance therapy; clinical implications for routine practice and future research
  • Long-term efficacy and safety observed with CPX-351 in the pivotal Phase III trial comparing that agent to standard 7 + 3 for newly diagnosed secondary AML; optimal integration into practice
  • Published efficacy findings with and ongoing and planned clinical trials evaluating CPX-351 alone or in combination with other agents in the treatment of primary AML

Treatment of AML with FLT3 or IDH1/2 Mutations

  • Optimal approaches to the management of newly diagnosed or relapsed/refractory AML with a FLT3 mutation; appropriate integration of gilteritinib into routine practice
  • Available data with gilteritinib combined with standard induction or consolidation chemotherapy for newly diagnosed AML; ongoing investigation of gilteritinib and other novel FLT3 inhibitors
  • Efficacy and safety findings leading to the FDA approval of ivosidenib for newly diagnosed IDH1-mutant AML in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy
  • Long-term follow-up data supporting the FDA approvals of ivosidenib and enasidenib for relapsed/refractory AML
  • Activity and safety of enasidenib as monotherapy and in combination with chemotherapy for patients with newly diagnosed AML and an IDH2 mutation
  • Design, eligibility criteria and emerging efficacy and safety findings from the Phase III AGILE study demonstrating improved event-free and overall survival with ivosidenib in combination with azacitidine compared to azacitidine monotherapy for patients with previously untreated AML with IDH1 mutations
  • Recognition and management of common and less frequent adverse events observed with FLT3 and IDH inhibitors
  • Efficacy of venetoclax-based therapy in patients with FLT3 or IDH1/2 mutations; ongoing research assessing venetoclax in combination with targeted therapy

PART II: MYELODYSPLASTIC SYNDROMES (MDS)

Current Management of MDS

  • Clinical and biologic factors guiding the selection and sequencing of therapy for patients with high-, intermediate- and low-risk MDS
  • Design, eligibility criteria and key endpoints of the ASTX727-01-B and ASTX727-02 (ASCERTAIN) studies evaluating the oral combination of decitabine and cedazuridine for patients with MDS
  • Response rates, duration of response and rates of transfusion independence achieved with oral decitabine/cedazuridine; FDA approval and current clinical role opposite standard IV decitabine
  • Mechanism of action of luspatercept; key efficacy and safety findings from the randomized Phase III MEDALIST trial evaluating luspatercept for patients with lower-risk MDS after failure of an erythropoiesis stimulating agent (ESA) who require red blood cell transfusions
  • FDA approval of luspatercept and optimal integration into practice; ongoing evaluation for ESA-naïve, low- to intermediate-risk MDS

Future Therapeutic Approaches for MDS

  • Activity observed with approved AML therapies (eg, venetoclax, ivosidenib, enasidenib, CC-486) in patients with MDS; current off-protocol roles
  • Recent FDA breakthrough therapy designation for venetoclax with azacitidine for treatment-naïve intermediate-, high- or very high-risk MDS; implications for clinical development
  • Biologic rationale for targeting CD47 in patients with MDS; available efficacy and safety findings with magrolimab in combination with azacitidine as first-line therapy for higher-risk disease
  • Ongoing evaluation and potential role of magrolimab in therapy for MDS and AML
  • Role of NEDD8-activating enzyme in cell growth and survival and its viability as a therapeutic target in MDS; mechanism of action of pevonedistat
  • Available efficacy and safety findings leading to the FDA breakthrough therapy designation for pevonedistat in combination with azacitidine for patients with higher-risk MDS; ongoing Phase III Pevonedistat-3001 (PANTHER) trial
  • Biologic justification for targeting TIM-3 in patients with MDS; mechanism of action of sabatolimab
  • Published results with sabatolimab in combination with a hypomethylating agent and ongoing studies attempting to further the development of sabatolimab
  • Available data with and ongoing evaluation of other promising agents for MDS

CLOSING COMMENTS | 4:20 PM ET

PROGRAM ADJOURNS | 4:30 PM ET

Target Audience
This live activity has been designed to meet the educational needs of medical oncologists, hematologists, hematology-oncology fellows, nurse practitioners, clinical nurse specialists and other allied cancer professionals involved in the treatment of cancer.

Learning Objectives

BREAST CANCER

  • Evaluate published research data to guide the selection and duration of neoadjuvant, adjuvant and extended adjuvant therapy for patients with localized HER2-overexpressing breast cancer.
  • Implement a long-term clinical plan for patients with metastatic HER2-positive breast cancer, incorporating existing and recently approved anti-HER2 therapies.
  • Recognize common and rare side effects associated with novel anti-HER2 agents, and use this information to develop supportive management plans for patients.
  • Evaluate the results of genomic assays and other patient- and treatment-related factors to personalize adjuvant systemic therapy for newly diagnosed ER-positive breast cancer.
  • Consider available clinical trial findings with CDK4/6 inhibitors for localized ER-positive, HER2-negative breast cancer, and assess the potential role of these agents in neoadjuvant or adjuvant treatment.
  • Individualize the selection and sequencing of systemic therapy for patients with metastatic ER-positive breast cancer, considering age, menopausal status, prior treatment course, PIK3CA mutation status, comorbidities, symptomatology and extent and sites of disease.
  • Appreciate available Phase III data documenting the efficacy of adjuvant PARP inhibition for patients with high-risk localized HER2-negative breast cancer with BRCA mutations, and consider the potential role of this strategy in clinical practice.
  • Review published research data supporting the benefit of chemotherapy in combination with anti-PD-1/PD-L1 antibodies for patients with localized or metastatic triple-negative breast cancer (TNBC), and use this information to make appropriate treatment recommendations.
  • Evaluate published research findings guiding the selection and sequencing of available therapeutic agents for patients with PD-L1-negative TNBC or those who experience disease progression on front-line chemoimmunotherapy.
  • Appraise published efficacy and safety data with PARP inhibitors for patients with metastatic breast cancer harboring BRCA1/2 mutations, and consider the diagnostic and therapeutic implications for nonresearch care.
  • Assess the mechanisms of action of, early data with and ongoing clinical trials evaluating other novel agents and treatment strategies under development for localized and metastatic breast cancer.

LUNG CANCER

  • Evaluate available and emerging data documenting the efficacy and safety of anti-PD-1/PD-L1 antibody-based approaches to neoadjuvant or adjuvant therapy for patients with nonmetastatic non-small cell lung cancer (NSCLC).
  • Appraise the FDA approval of anti-PD-L1 antibody consolidation therapy for patients with unresectable Stage III NSCLC who have not experienced disease progression after standard platinum-based chemotherapy concurrent with radiation therapy, and appropriately integrate this strategy into routine clinical practice.
  • Acknowledge the FDA approval of adjuvant EGFR tyrosine kinase inhibitor (TKI) therapy for early-stage NSCLC with EGFR mutation, and identify patients for whom treatment with this novel approach would be warranted.
  • Review published research data documenting the safety and efficacy of EGFR TKIs alone or in combination with other systemic approaches for metastatic NSCLC with an EGFR tumor mutation, and appropriately apply this information in patient care.
  • Assess the efficacy and safety of commercially available ALK inhibitors for patients with metastatic NSCLC with ALK rearrangements, and apply this understanding to select and sequence these drugs as first- and later-line therapy.
  • Recall published and emerging data with commercially available and experimental agents exploiting other oncogenic pathways (ie, ROS1, RET, MET, HER2, KRAS) mediating the pathogenesis of tumors in unique patient subsets.
  • Review recent therapeutic advances with anti-PD-1/PD-L1 antibodies as monotherapy or in combination with chemotherapy, chemobiologic therapy or anti-CTLA-4 antibodies for metastatic NSCLC, and discern how these approaches can be optimally employed in the management of this disease.
  • Appreciate available clinical trial findings informing the use of immune checkpoint inhibitors in combination with platinum-based chemotherapy for patients with previously untreated extensive-stage small cell lung cancer (SCLC).
  • Design an optimal approach to the clinical care of patients with progressive SCLC, considering the implications of prior therapeutic exposure, symptomatology and other factors.

GASTROINTESTINAL CANCERS

  • Develop a long-term care plan for patients diagnosed with metastatic colorectal cancer, considering biomarker profile, tumor location, exposure to prior systemic therapy, symptomatology, performance status (PS) and personal goals of treatment.
  • Use HER2 status, PD-L1 combined positive score and other clinical and biologic factors to optimize the selection and sequence of systemic therapy for locally advanced or metastatic gastric, gastroesophageal junction and esophageal cancers.
  • Consider age, PS, degree of liver function and other clinical factors in the selection of first- and later-line therapy for patients with unresectable or metastatic hepatocellular carcinoma.
  • Recall clinical trial data with approved and investigational systemic interventions for patients with localized, locally advanced or metastatic pancreatic adenocarcinoma, and establish an evidence-based approach to therapeutic selection.
  • Appreciate the molecular heterogeneity of cholangiocarcinomas, and apply available clinical research findings in individualizing therapy for patients with unresectable and metastatic disease.
  • Appraise available and emerging data with investigational agents currently in clinical testing for gastrointestinal cancers, and where applicable, refer eligible patients for clinical trial participation.

GENITOURINARY CANCERS

  • Evaluate the published research database supporting the FDA approvals of secondary hormonal agents in the management of nonmetastatic castration-resistant prostate cancer (CRPC), and apply this information in the recommendation of nonresearch treatment options for patients.
  • Explore available data with cytotoxic and secondary hormonal therapy for metastatic hormone-sensitive prostate cancer to design effective treatment plans for patients.
  • Apply clinical research findings in the determination of best-practice selection and sequencing of available treatment modalities for patients with metastatic CRPC.
  • Evaluate the rationale for the use of PARP inhibitors for patients with metastatic CRPC, and optimally incorporate these agents into clinical management algorithms.
  • Consider published and emerging research, clinical investigator perspectives and available guideline recommendations to individualize first-line therapy for patients with advanced renal cell carcinoma (RCC).
  • Develop a rational approach to the sequencing of systemic therapies for patients with advanced RCC who experience disease progression on first-line treatment, incorporating multikinase inhibitors, mTOR inhibitors and immunotherapeutic agents.
  • Recognize available clinical trial evidence with immune checkpoint inhibitors for nonmetastatic urothelial bladder carcinoma (UBC) to determine the current and potential utility of this strategy in clinical practice.
  • Review available clinical trial data with anti-PD-1/PD-L1 antibodies for patients with newly diagnosed or relapsed/refractory metastatic UBC in order to optimally incorporate these agents into current management algorithms.
  • Recall the mechanisms of action of and pivotal clinical trial findings with recently approved agents for previously treated locally advanced or metastatic UBC, and identify patients for whom treatment with these novel compounds would be appropriate.
  • Appraise available research data and ongoing clinical trials evaluating novel agents and strategies for prostate cancer, RCC and UBC, and counsel appropriately selected patients about participation in active protocols.

CHRONIC LYMPHOCYTIC LEUKEMIA AND LYMPHOMAS

  • Individualize the selection and sequencing of systemic therapy for patients with newly diagnosed or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), considering clinical presentation, age, performance status (PS), biomarker profile and coexisting medical conditions.
  • Understand published research data informing the selection, sequencing or combining of available therapeutic agents in the nonresearch care of patients with previously untreated or R/R follicular lymphoma (FL).
  • Apply knowledge of the mechanisms of action, efficacy and safety of approved and investigational agents for the treatment of diffuse large B-cell lymphoma (DLBCL) to determine the current and potential utility of those agents in clinical practice.
  • Consider patient age, PS and other clinical and biologic factors in decisions regarding up-front and subsequent treatment of mantle cell lymphoma (MCL).
  • Incorporate available and emerging therapeutic strategies into the best-practice management of newly diagnosed and R/R Hodgkin lymphoma.
  • Assess available clinical trial findings informing the utilization of CD19-directed chimeric antigen receptor T-cell therapy for R/R DLBCL, MCL and FL, and counsel appropriately selected patients regarding the potential benefits of this strategy.
  • Implement a plan of care to recognize and manage side effects and toxicities associated with existing and recently approved systemic therapies for CLL, FL, MCL, DLBCL and Hodgkin lymphoma to support quality of life and continuation of treatment.
  • Recall new data with agents and strategies currently under investigation for CLL and various lymphoma subtypes, and discuss ongoing trial opportunities with eligible patients.

MULTIPLE MYELOMA

  • Customize the selection of first-line therapy for newly diagnosed multiple myeloma (MM), considering patient- and disease-related factors, including cytogenetic profile and fitness for stem cell transplantation.
  • Appreciate clinical trial data informing the front-line use of monoclonal antibody therapy directed at CD38 for patients with MM eligible or ineligible for stem cell transplant, and identify when and how this strategy should be effectively integrated into clinical management.
  • Consider published research findings and other clinical factors in the best-practice selection, sequencing and combining of established regimens in the care of patients with relapsed/refractory MM.
  • Develop an understanding of the mechanisms of action of and pivotal clinical trial findings with recently FDA-approved therapies (eg, isatuximab, selinexor, belantamab mafodotin, melflufen) to facilitate their integration into MM management algorithms.
  • Evaluate the biologic rationale for the use of chimeric antigen receptor (CAR) T-cell therapy directed at BCMA (B-cell maturation antigen) as a targeted therapeutic strategy for MM, and identify patients for whom this novel strategy should be considered.
  • Recall the design of ongoing clinical trials evaluating novel agents and strategies for MM, and counsel appropriate patients about availability and participation.

ACUTE MYELOID LEUKEMIA AND MYELODYSPLASTIC SYNDROMES

  • Evaluate the importance of age, performance status and other biologic and disease-related factors in the selection and sequencing of therapy for patients with various presentations of acute myeloid leukemia (AML).
  • Appreciate the FDA approval of venetoclax in combination with azacitidine, decitabine or low-dose cytarabine for patients with newly diagnosed AML not eligible for intensive therapy, and identify individuals appropriate for treatment with this novel agent.
  • Review Phase III data documenting the efficacy of CC-486 as maintenance therapy for patients with newly diagnosed AML who achieved complete response or complete response with incomplete blood count recovery with induction chemotherapy, and consider how this novel strategy can be applied in clinical management.
  • Reflect on available research with approved and emerging FLT3 inhibitors, and use this information to guide clinical care and protocol opportunities for patients with newly diagnosed or progressive AML harboring a FLT3 mutation.
  • Develop an understanding of the mechanisms of action of, available data with and current role for available IDH1/2 inhibitors for patients with newly diagnosed or relapsed/refractory AML and an IDH1 or IDH2 mutation.
  • Assess the FDA-approved indications for CPX-351 for patients with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes, and discern how this agent can be safely and optimally integrated into nonresearch care algorithms.
  • Formulate a treatment algorithm for lower- and higher-risk myelodysplastic syndromes (MDS), considering patient- and disease-related factors, including cytogenetic abnormalities.
  • Recognize the recent FDA approval of the combination of decitabine and cedazuridine for intermediate- and high-risk MDS, and identify patients for whom treatment with this novel approach may be appropriate.
  • Describe the mechanism of action of luspatercept in the treatment of anemia secondary to MDS, and appraise how this agent can be appropriately integrated into clinical practice.
  • Develop an understanding of the biologic rationale for and available data with emerging novel combination approaches for patients with higher-risk MDS in order to prepare for the potential availability of these therapies in routine practice.
  • Recall promising agents and combination strategies under investigation for AML and MDS, and counsel appropriately selected patients regarding clinical trial enrollment.

Accreditation Statements
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Research To Practice is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation (ANCC).

CME Credit Designation Statement
Research To Practice designates this live activity for a maximum of 6 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

CME and ABIM MOC credit form links will be emailed to each participant within 5 business days of the activity.

American Board of Internal Medicine (ABIM) — Maintenance of Certification (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 6 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, this program has been specifically designed for the following ABIM specialties: medical oncology and hematology.

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NCPD Credit Designation Statements
This educational activity for 6 contact hours is provided by Research To Practice.

This activity is awarded 6 ANCC pharmacotherapeutic contact hours.

To obtain a certificate of completion and receive credit for this event, nurses must return a completed Educational Assessment and Credit Form for the modules they attend. The credit form links will be emailed to participants within 5 business days of the activity.

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This activity will be submitted to the ONCC for ILNA verification.

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There is no implied or real endorsement of any product by Research To Practice, ACCME or the ANCC. Any off-label use as declared by the FDA will be identified.

Content Validation and Disclosures
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest will have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTYDr Levis has no relevant conflicts of interest to disclose. The following faculty reported relevant financial relationships with ineligible entities:

Dr AgarwalConsulting Agreements: Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Bristol-Myers Squibb Company, Calithera Biosciences, Clovis Oncology, Eisai Inc, EMD Serono Inc, Exelixis Inc, Foundation Medicine, Genentech, a member of the Roche Group, Janssen Biotech Inc, Lilly, MEI Pharma Inc, Merck, Nektar, Novartis, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Seagen Inc. Dr Bekaii-SaabAdvisory Committee: Immuneering Corporation, Imugene, Sun Biopharma; Consulting Agreements (to Institution): Arcus Biosciences, Array BioPharma Inc, a subsidiary of Pfizer Inc, Bayer HealthCare Pharmaceuticals, Genentech, a member of the Roche Group, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Merck, Pfizer Inc, Seagen Inc; Consulting Agreements (to Self): AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Boehringer Ingelheim Pharmaceuticals Inc, Celularity, Daiichi Sankyo Inc, Eisai Inc, Exact Sciences Inc, Foundation Medicine, Janssen Biotech Inc, Kanaph Therapeutics, Natera Inc, Sobi, Stemline Therapeutics Inc, Treos Bio, Xilis; Research Funding (to Institution): AbGenomics, Agios Pharmaceuticals Inc, Amgen Inc, Arcus Biosciences, Arrys Therapeutics, a wholly owned subsidiary of Kyn Therapeutics, Atreca, Bayer HealthCare Pharmaceuticals, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, Genentech, a member of the Roche Group, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Lilly, Merck, Merus BV, Mirati Therapeutics, Novartis, Pfizer Inc, Seagen Inc, Sumitomo Dainippon Pharma Oncology Inc; Data and Safety Monitoring Board/Committee: 1Globe Health Institute, AstraZeneca Pharmaceuticals LP, Exelixis Inc, FibroGen, Kintor, Lilly, Pancreatic Cancer Action Network; Inventions/Patents: WO/2018/183488, WO/2019/055687. Dr CiomborAdvisory Committee: Array BioPharma Inc, a subsidiary of Pfizer Inc, Merck, Natera Inc, Pfizer Inc; Consulting Agreements: Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck; Contracted Research: Array BioPharma Inc, a subsidiary of Pfizer Inc, Bristol-Myers Squibb Company, Calithera Biosciences, Daiichi Sankyo Inc, Incyte Corporation, Merck, NuCana, Pfizer Inc. Dr KahlConsulting Agreements: AbbVie Inc, ADC Therapeutics, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Celgene Corporation, Epizyme Inc, Genentech, a member of the Roche Group, Pharmacyclics LLC, an AbbVie Company, Roche Laboratories Inc, TG Therapeutics Inc; Contracted Research: Acerta Pharma — A member of the AstraZeneca Group, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Genentech, a member of the Roche Group; Data and Safety Monitoring Board/Committee: Celgene Corporation, MEI Pharma Inc, Takeda Pharmaceuticals USA Inc. Dr PartridgeTravel Support: Novartis. Dr PegramAdvisory Committee: AstraZeneca Pharmaceuticals LP, bioTheranostics Inc, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Pfizer Inc, Sanofi Genzyme, Seagen Inc; Consulting Agreements: AstraZeneca Pharmaceuticals LP, bioTheranostics Inc, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Novartis, Pfizer Inc; Data and Safety Monitoring Board/Committee: AstraZeneca Pharmaceuticals LP. Dr PetrylakConsulting Agreements: Gilead Sciences Inc, Ipsen Biopharmaceuticals Inc; Contracted Research: Gilead Sciences Inc. Dr RajeAdvisory Committee: Amgen Inc, bluebird bio, Bristol-Myers Squibb Company, Caribou Biosciences Inc, GlaxoSmithKline, Immuneel Therapeutics, Janssen Biotech Inc. Dr SallmanAdvisory Committee: AbbVie Inc, Aprea Therapeutics, Bristol-Myers Squibb Company, Intellia Therapeutics, Kite, A Gilead Company, Novartis, Servier Pharmaceuticals LLC, Shattuck Labs, Syndax Pharmaceuticals Inc; Consulting Agreements: Magenta Therapeutics, Takeda Pharmaceuticals USA Inc; Contracted Research: Aprea Therapeutics, Jazz Pharmaceuticals Inc; Speakers Bureau: Bristol-Myers Squibb Company, Incyte Corporation, Servier Pharmaceuticals LLC. Dr SequistAdvisory Committee: AstraZeneca Pharmaceuticals LP, Janssen Biotech Inc, Pfizer Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Genentech, a member of the Roche Group; Data and Safety Monitoring Board/Committee: Genentech, a member of the Roche Group. Dr SpigelConsulting Agreements (to Institution): Amgen Inc, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Curio Science, EMD Serono Inc, Evidera, Exelixis Inc, Genentech, a member of the Roche Group, GlaxoSmithKline, Intellisphere LLC, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, Jazz Pharmaceuticals Inc, Lilly, Mirati Therapeutics, Molecular Templates, Novartis, Novocure Inc, Pfizer Inc, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Sanofi Genzyme; Contracted Research (to Institution): Aeglea BioTherapeutics, Agios Pharmaceuticals Inc, Apollomics Inc, Arcus Biosciences, Arrys Therapeutics, a wholly owned subsidiary of Kyn Therapeutics, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, BIND Therapeutics Inc, BioNTech AG, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol-Myers Squibb Company, Calithera Biosciences, Celgene Corporation, Celldex Therapeutics, Clovis Oncology, Cyteir Therapeutics, Daiichi Sankyo Inc, Denovo Biopharma, Eisai Inc, Elevation Oncology, EMD Serono Inc, Evelo Biosciences Inc, G1 Therapeutics Inc, Genentech, a member of the Roche Group, GlaxoSmithKline, Grail Inc, Hutchison MediPharma, ImClone Systems, a wholly owned subsidiary of Eli Lilly and Company, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, Kronos Bio, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, MacroGenics Inc, Merck, Molecular Partners, Molecular Templates, Nektar, Neon Therapeutics, Novartis, Novocure Inc, OncXerna Therapeutics Inc, Pfizer Inc, PTC Therapeutics, PureTech Health, Razor Genomics, Repare Therapeutics, Rgenix, Takeda Pharmaceuticals USA Inc, Tesaro, A GSK Company, Tizona Therapeutics Inc, Transgene, UT Southwestern Medical Center, Verastem Inc. Dr UsmaniAdvisory Committee: Amgen Inc, Bristol-Myers Squibb Company, Celgene Corporation, GlaxoSmithKline, Janssen Biotech Inc, Mundipharma, Oncopeptides, Sanofi Genzyme, Seagen Inc, Secura Bio, SkylineDx, Takeda Pharmaceuticals USA Inc, TeneoBio; Contracted Research: Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Bristol-Myers Squibb Company, Celgene Corporation, GlaxoSmithKline, Janssen Biotech Inc, Merck, Pharmacyclics LLC, an AbbVie Company, Sanofi Genzyme, Seagen Inc, SkylineDx, Takeda Pharmaceuticals USA Inc; Speakers Bureau: Amgen Inc, Bristol-Myers Squibb Company, Janssen Biotech Inc, Sanofi Genzyme. Dr ZelenetzConsulting Agreements: AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Celgene Corporation, Cultura e Eventos LTDA, Curio Science, DAVA Oncology, Debiopharm, Gilead Sciences Inc, Instituto de Ciências Integradas, Juno Therapeutics, a Celgene Company, Karyopharm Therapeutics, Kite, A Gilead Company, MEI Pharma Inc, MorphoSys, Oncopeptides, Ono Pharmaceutical Co Ltd, Quant Health, Sandoz Inc, a Novartis Division, Suzhou Liangyihui Network Technology Co Ltd, Vaniam Group, Verastem Inc; Contracted Research: AbbVie Inc, BeiGene Ltd, Genentech, a member of the Roche Group, Gilead Sciences Inc, MEI Pharma Inc, MethylGene Inc; Data and Safety Monitoring Board/Committee: BeiGene Ltd (DMC Chair), Bristol-Myers Squibb Company, Celgene Corporation, Juno Therapeutics, a Celgene Company; Scientific Advisory Board Chair: Lymphoma Research Foundation; Other: NCCN (B-Cell Lymphoma Panel Chair).

MODERATORDr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: AbbVie Inc, Adaptive Biotechnologies Corporation, ADC Therapeutics, Agios Pharmaceuticals Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, Coherus BioSciences, Daiichi Sankyo Inc, Eisai Inc, Epizyme Inc, Exact Sciences Inc, Exelixis Inc, Five Prime Therapeutics Inc, Foundation Medicine, G1 Therapeutics Inc, Genentech, a member of the Roche Group, Genmab, Gilead Sciences Inc, GlaxoSmithKline, Grail Inc, Halozyme Inc, Helsinn Healthcare SA, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Kite, A Gilead Company, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Natera Inc, Novartis, Novocure Inc, Oncopeptides, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Sanofi Genzyme, Seagen Inc, Servier Pharmaceuticals LLC, Sumitomo Dainippon Pharma Oncology Inc, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, Tesaro, A GSK Company, TG Therapeutics Inc, Turning Point Therapeutics Inc and Verastem Inc.

Research To Practice CME/NCPD Planning Committee Members, Staff and Reviewers — Planners, scientific staff and independent reviewers for Research To Practice have no relevant conflicts of interest to disclose.

Supporters
This activity is supported by educational grants from Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo Inc, Eisai Inc, Exact Sciences Inc, G1 Therapeutics Inc, Genentech, a member of the Roche Group, Incyte Corporation, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Merck, Natera Inc, Novartis, Oncopeptides, Pharmacyclics LLC, an AbbVie Company and Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc and Sanofi Genzyme, Sanofi Genzyme, Seagen Inc, Taiho Oncology Inc, and Takeda Pharmaceuticals USA Inc.