Wednesday, August 4, 2021, 5:00 PM – 6:30 PM Eastern Time (ET)

Consensus or Controversy? Clinical Investigator Perspectives on the Current and Future Management of Hepatocellular Carcinoma and Pancreatic Cancer

A Live CME/MOC Webinar Held Adjunct to the 2021 ASCO Annual Meeting

Join us on Wednesday, August 4th for this CME/MOC-accredited webinar
5:00 PM – 6:30 PM ET

Faculty

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
Phoenix, Arizona

Kim A Reiss Binder, MD
Assistant Professor
Abramson Cancer Center
University of Pennsylvania
Philadelphia, Pennsylvania

Eileen M O’Reilly, MD
Winthrop Rockefeller Endowed Chair in Medical Oncology
Section Head, Hepatopancreaticobiliary and Neuroendocrine Cancers
Co-Director, Medical Initiatives
David M Rubenstein Center for Pancreatic Cancer Research
Attending Physician, Member
Memorial Sloan Kettering Cancer Center
Professor of Medicine, Weill Cornell Medical College
New York, New York

Philip A Philip, MD, PhD, FRCP
Kathryn Cramer Endowed Chair in Cancer Research
Professor of Oncology and Pharmacology
Leader, GI and Neuroendocrine Oncology
Karmanos Cancer Institute
Wayne State University
Detroit, Michigan

Moderator
Neil Love, MD
Research To Practice
Miami, Florida


Not an official event of the 2021 ASCO Annual Meeting. Not sponsored, endorsed, or accredited by ASCO®, CancerLinQ®, or Conquer Cancer® the ASCO Foundation.

This activity is supported by educational grants from Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo Inc, Eisai Inc, Exelixis Inc, Lilly, Merck and Taiho Oncology Inc.

Hepatocellular Carcinoma (HCC)

  • Clinical and biologic factors in the selection of first-line treatment for patients with advanced HCC (eg, age, performance status, symptomatology, Child-Pugh score)
  • 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
  • Design, entry criteria and key efficacy and safety findings from the Phase III IMbrave150 trial evaluating first-line atezolizumab/bevacizumab versus sorafenib for advanced, unresectable HCC; FDA approval of atezolizumab/bevacizumab and patient selection for first-line therapy with this regimen
  • Mechanism of action of sintilimab; recently presented results from the Phase II/III ORIENT-32 trial comparing the efficacy and safety of sintilimab in combination with a bevacizumab biosimilar to that of sorafenib as first-line treatment for advanced HCC
  • Optimal management of HCC in patients with compromised hepatic function, poor performance status and/or other comorbidities in the first-line setting
  • Selection and sequencing of approved agents and regimens for patients with disease progression on first-line therapy; impact of the increased use of first-line atezolizumab/bevacizumab on second- and later-line therapy decision-making
  • Long-term outcomes with approved multikinase inhibitors (eg, regorafenib, cabozantinib) for previously treated advanced HCC
  • Published efficacy and safety data with the use of an anti-PD-1/PD-L1 antibody alone or in combination with an anti-CTLA4 antibody for patients with relapsed or refractory HCC
  • Clinical implications of the negative overall survival results from the Phase III CheckMate 459 trial of nivolumab versus sorafenib as first-line therapy for patients with advanced HCC; FDA advisory committee review of the single-agent nivolumab indication of HCC previously treated with sorafenib
  • Previously treated HCC as the indication for the combination of nivolumab and ipilimumab approved by the FDA on the basis of the results of the Phase I/II CheckMate 040 trial (Cohort 4); current clinical role of this combination
  • Design, entry criteria and key endpoints of the Phase III CheckMate 9DW trial comparing nivolumab in combination with ipilimumab to sorafenib or lenvatinib as first-line therapy for advanced HCC
  • Active Phase III trials investigating the benefit of combining an immune checkpoint inhibitor with a TKI as first-line therapy for patients with newly diagnosed advanced HCC (eg, LEAP-002, COSMIC-312); potential clinical role of these regimens
  • Early efficacy and safety findings with the combination of durvalumab and tremelimumab as first- or second-line therapy for patients with advanced HCC
  • Design, eligibility criteria and key efficacy and safety endpoints of the Phase III HIMALAYA trial comparing durvalumab alone or in combination with tremelimumab to sorafenib as first-line therapy for patients with advanced HCC
  • Biologic rationale for, available clinical trial data with and ongoing investigation of the combination of an immune checkpoint inhibitor with a TKI (eg, lenvatinib, cabozantinib) for newly diagnosed and previously treated advanced HCC
  • Optimal selection of third-line therapy for patients with HCC; available data sets with FDA-approved agents and regimens for multiregimen-relapsed disease
  • Prognosis for patients with AFP-high (≥400 ng/mL) HCC; effect of AFP level on treatment outcomes and therapy decision-making
  • Published results from the Phase III REACH-2 trial of ramucirumab for AFP-high relapsed or refractory HCC; patient selection for treatment with ramucirumab
  • Other promising agents and strategies currently under investigation for HCC

Pancreatic Cancer

  • Factors determining the use of neoadjuvant systemic therapy versus immediate surgery for patients with resectable pancreatic adenocarcinoma (PAD); role of contemporary cytotoxic regimens (eg, modified FOLFIRINOX, nab paclitaxel/gemcitabine) in this setting
  • Selection of adjuvant systemic therapy for patients with resected PAD
  • Key efficacy results from the Phase III APACT trial evaluating adjuvant nab paclitaxel/gemcitabine versus gemcitabine alone for patients with resected PAD; nonresearch role, if any, of the combination
  • Optimal selection of first-line therapy; impact of the neoadjuvant/adjuvant use of contemporary chemotherapy regimens on the selection of therapy for patients with metastatic PAD
  • Patient selection for and practical implementation of first-line FOLFIRINOX, modified FOLFIRINOX or nab paclitaxel/gemcitabine for metastatic PAD; predictors of response, if any
  • Published research with, patient selection for and practical integration of nal-IRI for relapsed metastatic PAD
  • Side effects and toxicities associated with nal-IRI (eg, hypersensitivity, interstitial lung disease) and indications for dose delay, dose reduction and treatment discontinuation
  • Early front-line activity observed with NALIRIFOX in patients with locally advanced or metastatic pancreatic cancer
  • Design, eligibility criteria and key endpoints of the Phase III NAPOLI-3 trial comparing first-line NALIRIFOX to nab paclitaxel/gemcitabine for metastatic PAD
  • Selection and sequencing of therapy for patients with resectable, borderline resectable and unresectable pancreatic cancer
  • Incidence of BRCA1/2 mutations and other DNA damage repair abnormalities among patients with PAD; guideline-endorsed algorithms for genetic testing
  • Key efficacy and safety findings from the Phase III POLO trial supporting the FDA approval of olaparib as maintenance therapy for patients with metastatic PAD and a germline BRCA mutation after first-line platinum-based chemotherapy; optimal integration into clinical practice
  • Frequency, severity and timing of adverse events associated with olaparib; monitoring and optimal management of Grade ≥3 adverse events in patients with PAD
  • Biologic rationale for the design of the ongoing Phase II APOLLO trial evaluating olaparib versus placebo after adjuvant chemotherapy for patients with resected pancreatic cancer harboring a pathogenic BRCA1/2 or PALB2 mutation
  • Other PARP inhibitors (eg, niraparib, rucaparib) under investigation for PAD; biologic rationale for and ongoing investigation of PARP inhibitors combined with other anticancer therapies for metastatic PAD
  • Design, entry criteria and key endpoints of the Phase III PANOVA-3 trial evaluating tumor treating fields concomitant with gemcitabine and nab paclitaxel as front-line treatment of locally advanced PAD
  • Potential clinical role of immune checkpoint inhibitors alone or in combination with chemotherapy or targeted therapy for patients with metastatic pancreatic cancer; ongoing investigations (eg, SWOG-S2001)
  • Other novel agents and strategies under investigation for pancreatic cancer

Target Audience
This program is intended for medical oncologists, hematology-oncology fellows and other allied healthcare professionals involved in the treatment of gastrointestinal cancers.

Learning Objectives

  • Consider patient age, performance status, liver function and other clinical and logistical factors in the selection of first- and later-line therapy for unresectable or metastatic hepatocellular carcinoma (HCC).
  • Appreciate the Phase III data leading to the FDA approval of atezolizumab in combination with bevacizumab as first-line therapy for unresectable or metastatic HCC, and discuss how this combination can be optimally integrated into the clinical care of patients.
  • Acknowledge Phase I/II data supporting the FDA approval of the combination of nivolumab and ipilimumab for patients with HCC who have previously received sorafenib, and consider the current clinical role of this regimen.
  • Recall the Phase III data leading to the FDA approval of olaparib as maintenance therapy for patients with metastatic pancreatic adenocarcinoma (PAD) with deleterious or suspected deleterious germline BRCA mutations and without disease progression on a first-line platinum-based chemotherapy regimen.
  • Apply clinical trial data with approved and investigational systemic interventions for patients with localized, locally advanced or metastatic PAD to establish an evidence-based approach to selecting therapy.
  • Appraise available and emerging data with investigational agents currently in clinical testing for HCC and PAD, and appropriately refer eligible patients for clinical trial participation.

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

Accreditation Statement
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Credit Designation Statement
Research To Practice designates this live activity for a maximum of 1.5 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in 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 1.5 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 specialty: medical oncology.

Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information. For those clinicians wishing to receive ABIM MOC credit for attending, you will receive an email after the event with instructions.

Disclosure Policy
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education. We assess conflicts of interest with faculty, planners and managers of CME activities. Conflicts of interest are identified and resolved through a conflict of interest resolution process. In addition, all activity content is reviewed by both a member of the RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant conflicts of interest, which have been mitigated through a conflict of interest mitigation process:

Dr Bekaii-SaabAdvisory Committee: Immuneering Corporation, Imugene, Sun Biopharma; Consulting Agreements (to Institution): 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, 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: AstraZeneca Pharmaceuticals LP, Exelixis Inc, Merck, Pancreatic Cancer Action Network; Inventions/Patents: WO/2018/183488, WO/2019/055687. Dr BinderContracted Research: Bristol-Myers Squibb Company, Clovis Oncology, GlaxoSmithKline. Dr O’ReillyConsulting Agreements: Agios Pharmaceuticals Inc, Alnylam Pharmaceuticals Inc, AstraZeneca Pharmaceuticals LP, Autem Medical, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Berry Genomics, Celgene Corporation, Cend Therapeutics Inc, CytomX Therapeutics, Eisai Inc, Exelixis Inc, Flatiron Health, Genentech, a member of the Roche Group, Genoscience Pharma, Helio Health, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Legend Biotech, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, MiNA Therapeutics, QED Therapeutics, Rafael Pharmaceuticals Inc, RedHill Biopharma Ltd, Silenseed Ltd, SillaJen, Sobi, Surface Oncology, TheraBionic, twoXAR Inc, Vector Pharma, Yiviva; Contracted Research: Agios Pharmaceuticals Inc, Arcus Biosciences, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BioNTech, Bristol-Myers Squibb Company, Celgene Corporation, Flatiron Health, Genentech, a member of the Roche Group, Genoscience Pharma, Incyte Corporation, Polaris Pharmaceuticals, Puma Biotechnology Inc, QED Therapeutics, SillaJen, Yiviva. Dr PhilipAdvisory Committee: Array BioPharma Inc, a subsidiary of Pfizer Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Caris Life Sciences, Celgene Corporation, Daiichi Sankyo Inc, Eisai Inc, Ipsen Biopharmaceuticals Inc, Merck, Merus BV, Novartis, Pfizer Inc, QED Therapeutics, Rafael Pharmaceuticals Inc; Consulting Agreements: Blueprint Medicines, Erytech, IQVIA, Merck, Rafael Pharmaceuticals Inc, SynCore Biotechnology, TriSalus Life Sciences; Contracted Research: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Biolinx, Bristol-Myers Squibb Company, Celgene Corporation, Corcept Therapeutics, Daiichi Sankyo Inc, Eisai Inc, Five Prime Therapeutics Inc, Forty Seven Inc, Gritstone Oncology, Incyte Corporation, IQVIA, Karyopharm Therapeutics, Merck, Merus BV, Natera Inc, NGM Biopharmaceuticals, Novartis, Novocure Inc, QED Therapeutics, Rafael Pharmaceuticals Inc, SynCore Biotechnology, Taiho Oncology Inc, TriSalus Life Sciences, Tyme Inc; Data and Safety Monitoring Board/Committee: ASLAN Pharmaceuticals, Blueprint Medicines, Erytech; Speakers Bureau: Advanced Accelerator Applications, Bayer HealthCare Pharmaceuticals, Celgene Corporation, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Novartis.

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, Genentech, a member of the Roche Group, 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, Novartis, Novocure Inc, Oncopeptides, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Sanofi Genzyme, Seagen Inc, Sumitomo Dainippon Pharma Oncology Inc, Taiho Oncology Inc, Takeda Oncology, Tesaro, A GSK Company, TG Therapeutics Inc, Turning Point Therapeutics Inc and Verastem Inc.

RESEARCH TO PRACTICE CME 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, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo Inc, Eisai Inc, Exelixis Inc, Lilly, Merck and Taiho Oncology Inc.