Module 1
Breast Cancer | 9:00 AM – 10:00 AM ET

Localized Breast Cancer

• Clinicopathologic factors affecting the risk of recurrence and the decision to consult a genomic classifier for ER-positive localized breast cancer
• Recommended approaches to biomarker assessment (eg, BRCA, PD-L1, Ki-67) for localized breast cancer
• Long-term findings from the Phase III TAILORx and RxPONDER trials; implications for practice
• Other recent studies informing the use of the 21-gene Recurrence Score^® to guide neoadjuvant and adjuvant treatment decision-making
• Current approaches to the management of ER-positive localized disease in premenopausal patients; optimal duration and timing of ovarian suppression
• Key efficacy and safety outcomes from the Phase III monarchE trial with the addition of abemaciclib to standard adjuvant hormonal therapy for patients with ER-positive, HER2-negative breast cancer who are at high risk for recurrence
• Guideline-endorsed indications for the use of adjuvant abemaciclib; identification of appropriate patients for this strategy
• Major findings 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 localized triple-negative breast cancer (TNBC)
• FDA approval of (neo)adjuvant pembrolizumab; practical implementation and selection of appropriate candidates for this treatment strategy
• Key efficacy and safety data, including overall survival outcomes, from the Phase III OlympiA trial evaluating adjuvant olaparib versus placebo for patients with high-risk HER2-negative breast cancer and germline BRCA1/2 mutations
• Guideline-endorsed indications for the use of adjuvant olaparib; identification of patients for this approach
• Key clinical factors in the selection of neoadjuvant and adjuvant systemic therapy for HER2-positive localized breast cancer
• Published clinical research with postadjuvant neratinib for HER2-positive localized breast cancer; identification of patients for treatment with neratinib
• Dose escalation and other available approaches to mitigate neratinib-associated gastrointestinal toxicities

Metastatic Breast Cancer (mBC)

• Clinical factors (eg, prior HER2-directed therapy, symptomatology, disease-free interval, sites of metastases) affecting the selection and sequencing of therapy for patients with HER2-positive mBC
• Long-term results, including final overall survival (OS) data, from the HER2CLIMB study of tucatinib/trastuzumab/capecitabine for HER2-positive mBC
• Findings from key studies (eg, DESTINY-Breast01, DESTINY-Breast03) evaluating trastuzumab deruxtecan (T-DXd) for HER2-positive mBC
• CNS activity observed with tucatinib/trastuzumab/capecitabine and T-DXd in the pivotal studies leading to their approvals and other research efforts (eg, the TUXEDO-1 trial) for patients with brain metastases
• Spectrum, frequency and severity of toxicities associated with approved HER2-targeted agents for mBC; recommendations for monitoring, prevention and management
• Long-term follow-up, including OS findings, from pivotal clinical trials of the CDK4/6 inhibitors palbociclib, ribociclib and abemaciclib for ER-positive mBC
• Evidence-based selection of a CDK4/6 inhibitor and an endocrine partner for premenopausal and postmenopausal patients
• Available (eg, MAINTAIN trial) and emerging (eg, PACE trial) data evaluating the clinical utility of rechallenge with a CDK4/6 inhibitor in patients who have experienced disease progression on or after prior CDK4/6 inhibitor therapy; implications for later-line treatment
• Incidence of HER2-low breast cancer; optimal timing and approach to testing
• Published findings from the DESTINY-Breast04 trial evaluating T-DXd versus chemotherapy in patients with previously treated HER2-low advanced breast cancer; FDA approval and optimal integration into current algorithms
• Key findings from the Phase III TROPiCS-02 trial evaluating sacituzumab govitecan for ER-positive, HER2-negative mBC; potential role of sacituzumab govitecan for this population
• Design, eligibility criteria and emerging efficacy and safety data from the Phase III CAPItello-291 study evaluating capivasertib and fulvestrant versus placebo and fulvestrant for recurrent HR-positive, HER2-negative mBC; potential clinical role
• Available and emerging findings with oral SERDs (eg, elacestrant, camizestrant, imlunestrant)
• Mechanism of action of and available data with datopotamab deruxtecan for mBC
• Key clinical research findings guiding the optimal use of immune checkpoint inhibitors and PARP inhibitors for metastatic TNBC (mTNBC)
• Results from the Phase III ASCENT trial comparing sacituzumab govitecan to physician’s choice of chemotherapy for mTNBC
• Evidence-based sequencing of sacituzumab govitecan for relapsed/refractory mTNBC

Module 2
Gastrointestinal Cancers | 10:00 AM – 11:00 AM ET

Colorectal Cancer (CRC) and Gastroesophageal Cancers

• Mechanistic rationale for and available data with longitudinal circulating tumor DNA (ctDNA)/minimal residual disease (MRD) monitoring for localized CRC
• Ongoing studies examining the clinical utility of ctDNA/MRD testing for treatment decision-making and monitoring for recurrence; potential clinical impact
• Recently presented results from the Phase III PARADIGM trial and implications for the use of EGFR antibody therapy as a component of first-line treatment
• Appropriate integration of encorafenib/cetuximab into clinical practice for BRAF V600E-mutant metastatic CRC (mCRC)
• Updated data from the Phase II DESTINY-CRC01 study of trastuzumab deruxtecan (T-DXd) for HER2-expressing mCRC
• Efficacy and safety findings from the pivotal Phase II MOUNTAINEER trial evaluating tucatinib/trastuzumab for previously treated HER2-positive mCRC
• Potential nonresearch role of T-DXd and tucatinib/trastuzumab for HER2-positive mCRC
• Incidence of KRAS G12C mutations in patients with mCRC; early results with and ongoing evaluation of KRAS G12C inhibitors (eg, sotorasib, adagrasib) for KRAS G12C-mutant disease
• Key data informing the rational incorporation of pembrolizumab, nivolumab and nivolumab/ipilimumab into therapy for microsatellite instability-high/mismatch repair-deficient mCRC
• Long-term findings from pivotal Phase III trials assessing regorafenib and TAS-102 for multiregimen-relapsed CRC
• Patient selection and practical considerations, including optimal dosing, for the use of regorafenib in mCRC
• Available data with TAS-102 in combination with bevacizumab for mCRC; emerging findings from the Phase III SUNLIGHT trial and implications for clinical practice
• Published outcomes from the Phase III CheckMate 577 study of adjuvant nivolumab for resected esophageal or gastroesophageal junction (GEJ) cancer; appropriate selection of candidates for this strategy
• Available (eg, CheckMate 649, CheckMate 648, KEYNOTE-590 trials) and emerging (eg, KEYNOTE-859 trial) Phase III data sets demonstrating the efficacy and safety of first-line checkpoint inhibitor-containing regimens for advanced gastric, GEJ and esophageal cancer
• Evidence-based selection of chemotherapy alone, combined chemoimmunotherapy or dual immune checkpoint inhibition for newly diagnosed gastroesophageal tumors; impact of PD-L1 expression, tumor location and histology on decision-making
• Principal outcomes from the Phase III KEYNOTE-811 trial supporting the use of first-line pembrolizumab/trastuzumab/chemotherapy for HER2-positive metastatic gastric/GEJ adenocarcinoma
• Published efficacy and safety data from the DESTINY-Gastric01 and DESTINY-Gastric02 trials of T-DXd for progressive HER2-positive gastric/GEJ cancer
• Optimal sequencing of T-DXd in therapy for HER2-positive metastatic gastric/GEJ adenocarcinoma
• Biologic rationale for and ongoing evaluation of tucatinib-containing therapy for patients with previously treated HER2-positive gastric/GEJ adenocarcinoma
• Published findings with and optimal integration of ramucirumab into current clinical algorithms for metastatic gastric/GEJ cancer; role for patients experiencing disease progression on an immune checkpoint inhibitor
• Biologic rationale for targeting claudin 18.2 in gastric/GEJ cancer; mechanism of action of and early efficacy and safety data with zolbetuximab
• Emerging positive findings from the Phase III SPOTLIGHT study of first-line zolbetuximab in combination with chemotherapy for claudin 18.2-positive metastatic gastric/GEJ cancer
• Major efficacy and safety data with and ongoing evaluation of bemarituzumab/chemotherapy as first-line therapy for FGFR2b-positive metastatic gastric/GEJ cancer

Hepatobiliary Cancers and Pancreatic Cancer 

• Clinical and biologic factors affecting the selection of first- and later-line therapy for advanced hepatocellular carcinoma (HCC)
• Long-term efficacy and safety findings from the Phase III IMbrave150 study establishing the benefit of first-line atezolizumab/bevacizumab for unresectable HCC
• Current role of atezolizumab/bevacizumab; practical integration and patient selection
• Design, eligibility criteria and key endpoints of the Phase III HIMALAYA trial evaluating durvalumab/tremelimumab versus durvalumab alone as first-line treatment for unresectable advanced HCC
• Overall survival advantage and other key efficacy outcomes with durvalumab/tremelimumab in the HIMALAYA trial; recent FDA approval and current clinical role
• Mechanism of action of tislelizumab; comparison to commercially available anti-PD-1/PD-L1 antibodies
• Available results from the Phase III RATIONALE 301 trial comparing tislelizumab to sorafenib as first-line treatment for advanced unresectable HCC; potential clinical role
• Current clinical utility of tyrosine kinase inhibitor monotherapy as first-line treatment for unresectable HCC; recently presented findings demonstrating a potential advantage with lenvatinib compared to atezolizumab/bevacizumab for nonviral disease
• Long-term outcomes with approved anti-angiogenic agents (eg, regorafenib, cabozantinib, ramucirumab) among patients with progressive HCC
• Key findings with anti-PD-1/PD-L1 and anti-CTLA-4 combination regimens for progressive HCC
• Design, eligibility criteria and key efficacy and safety findings from the Phase III TOPAZ-1 trial evaluating durvalumab in combination with chemotherapy as first-line treatment for advanced biliary tract cancers (BTCs)
• Published findings evaluating the addition of liposomal irinotecan (nal-IRI) to 5-FU/leucovorin for progressive metastatic BTCs
• Spectrum of molecular alterations in cholangiocarcinoma and other BTCs; utility of genomic analyses to identify potentially actionable molecular abnormalities
• Key efficacy and safety findings leading to the FDA approvals of pemigatinib, infigratinib and futibatinib for previously treated, FGFR-altered locally advanced or metastatic cholangiocarcinoma; optimal integration of these agents into current disease management algorithms
• Ongoing trials evaluating FGFR inhibitors as first-line therapy for patients with treatment-naïve cholangiocarcinoma (eg, FIGHT-302, PROOF, FOENIX-CCA3)
• Published outcomes from the Phase III ClarIDHy study of ivosidenib for cholangiocarcinoma with an IDH1 mutation; FDA approval and optimal incorporation of this agent into clinical practice
• Efficacy and safety of T-DXd in patients with HER2-positive and HER2-low BTCs in the Phase II HERB study
• Optimal selection of first- and later-line treatment for patients with metastatic pancreatic adenocarcinoma (PAD); impact of age, comorbidities and prior therapy
• Emerging findings from the Phase III NAPOLI-3 trial demonstrating a statistically significant improvement in overall survival with the combination of nal-IRI, 5-FU/ leucovorin and oxaliplatin (NALIRIFOX) compared to nab paclitaxel/gemcitabine for previously untreated PAD; clinical implications
• Patient selection for and practical integration of nal-IRI for relapsed metastatic PAD
• Frequency of germline BRCA mutations and other DNA damage repair alterations in PAD; indications for and practical implementation of genetic testing
• Long-term findings with and optimal integration of olaparib as maintenance therapy after first-line chemotherapy for metastatic PAD with a germline BRCA mutation
• Potential role of KRAS mutation as a therapeutic target in PAD; early results with and ongoing evaluation of sotorasib and adagrasib for KRAS G12C-mutant advanced disease

Morning Break | 11:00 AM – 11:20 AM ET

Module 3
Genitourinary Cancers | 11:20 AM – 12:20 PM ET

Prostate Cancer

• Indications for and selection of androgen deprivation therapy (ADT) for patients with prostate cancer
• Available research findings with abiraterone in combination with ADT for high-risk nonmetastatic prostate cancer; potential clinical role
• Major efficacy and safety results from the Phase III PRESTO study evaluating ADT intensification with apalutamide with or without abiraterone for patients with biochemically recurrent prostate cancer and a rapid PSA doubling time; implications for practice
• Ongoing clinical trials evaluating androgen receptor (AR) pathway inhibitors in combination with ADT and/or radiation therapy for patients with high-risk nonmetastatic prostate cancer
• Clinical, biologic and practical factors guiding the selection of enzalutamide, apalutamide or darolutamide for patients with nonmetastatic castration-resistant prostate cancer (CRPC)
• Considerations in the choice of abiraterone, enzalutamide, apalutamide or docetaxel in combination with ADT for metastatic hormone-sensitive prostate cancer (mHSPC)
• Design, eligibility criteria and key efficacy and safety data from the Phase III PEACE-1 study of docetaxel with or without abiraterone with or without local radiation therapy for mHSPC
• Key findings from the Phase III ARASENS trial of darolutamide in combination with docetaxel and ADT for mHSPC; FDA approval and current clinical role
• Factors in the selection and sequencing of therapy for patients with metastatic CRPC (mCRPC)
• Radium-223 chloride: Published research, optimal clinical use and ongoing evaluation
• Phase III findings leading to the FDA approval of ¹⁷⁷Lu-PSMA-617 for progressive PSMA-positive mCRPC; integration into clinical practice
• Design, eligibility criteria and emerging findings from the Phase III PSMAfore trial comparing ¹⁷⁷Lu-PSMA-617 to a change in AR-directed therapy for mCRPC previously treated with an alternate AR pathway inhibitor but not exposed to taxane-containing chemotherapy
• Early results with and ongoing evaluation of ¹⁷⁷Lu-PSMA-617 in combination with other systemic therapies
• Appropriate integration of cabazitaxel into current mCRPC treatment algorithms and practical considerations for its use
• Frequency of homologous recombination repair (HRR) gene mutations in prostate cancer; indications for and practical implementation of genetic testing
• Optimal integration of approved PARP inhibitors into the care of men with mCRPC
• Results from the Phase III TRITON3 trial evaluating rucaparib versus physician’s choice of therapy for patients with mCRPC and HRR pathway abnormalities; implications for management algorithms
• Efficacy and safety findings from the Phase III PROpel trial comparing olaparib in combination with abiraterone to abiraterone alone as first-line therapy for patients with mCRPC with and without HRR gene mutations
• Results of the Phase III MAGNITUDE study of niraparib with abiraterone/prednisone as first-line therapy for patients with mCRPC with and without HRR gene mutations
• Design, eligibility criteria and emerging efficacy and safety findings from the Phase III TALAPRO-2 trial comparing talazoparib in combination with enzalutamide to enzalutamide alone for patients with mCRPC with and without HRR gene mutations
• Potential clinical role of PARP inhibitors in combination with AR pathway inhibitors as first-line treatment for patients with and without HRR mutations

Bladder and Kidney Cancer

• Identification of patients with high-risk non-muscle-invasive bladder cancer (NMIBC) appropriate for pembrolizumab therapy
• Results of the Phase III CheckMate 274 trial comparing nivolumab to placebo after surgery for patients with high-risk muscle-invasive bladder cancer (MIBC)
• FDA approval of adjuvant nivolumab and optimal integration into routine practice
• Current clinical research attempting to further define the role of anti-PD-1/PD-L1 antibodies in therapy for NMIBC and MIBC; ramifications of the recent voluntary indication withdrawal for atezolizumab
• Mechanism of antitumor activity of the novel intravesical drug delivery system TAR-200; early trial data
• Ongoing studies of TAR-200 with and without the anti-PD-1 antibody cetrelimab for NMIBC and MIBC
• Current clinical roles of anti-PD-1/PD-L1 antibodies as monotherapy and as maintenance therapy for patients with previously untreated metastatic urothelial bladder cancer (mUBC)
• Long-term outcomes with enfortumab vedotin for patients with progressive mUBC; appropriate integration into the treatment paradigm
• Recently presented results from cohort K of the EV-103/KEYNOTE-869 study of first-line enfortumab vedotin in combination with pembrolizumab; implications for disease management
• Extended follow-up with erdafitinib for patients with mUBC and FGFR3 or FGFR2 genetic alterations; current role in clinical practice
• Principal efficacy and safety findings with sacituzumab govitecan for progressive mUBC; optimal incorporation into disease management
• Spectrum, incidence and severity of toxicities with enfortumab vedotin, erdafitinib or sacituzumab govitecan; mitigation and management strategies
• Key efficacy and safety findings from the Phase III KEYNOTE-564 trial documenting the benefit of adjuvant pembrolizumab for patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence after nephrectomy
• Identification of patients for treatment with adjuvant pembrolizumab
• Clinical and biologic factors in the selection of first-line therapy for patients with newly diagnosed metastatic RCC (mRCC)
• Long-term findings with nivolumab/ipilimumab, pembrolizumab/axitinib and avelumab/axitinib for treatment-naïve mRCC
• Principal findings from the Phase III CheckMate 9ER trial establishing the efficacy of nivolumab in combination with cabozantinib for previously untreated mRCC; FDA approval and current role
• Major efficacy and safety data from the Phase III CLEAR trial leading to the FDA approval of lenvatinib with pembrolizumab as first-line therapy for mRCC; optimal integration into current management algorithms
• Design, eligibility criteria and key efficacy and safety findings from the pivotal Phase III COSMIC-313 trial evaluating nivolumab/ipilimumab/cabozantinib versus nivolumab/ipilimumab for previously untreated advanced intermediate- or poor-risk RCC; implications for patient care
• Clinical and biologic factors in the selection of treatment for patients with mRCC who experience disease progression on first-line therapy
• Optimal incorporation of tivozanib into current management algorithms; ongoing studies attempting to further define the role of this agent in RCC management
• Mechanism of action of belzutifan; available data, ongoing evaluation and current clinical role in therapy for kidney cancer

Lunch Break | 12:20 PM – 1:05 PM ET

Module 4
Chronic Lymphocytic Leukemia and Lymphomas | 1:05 PM – 2:05 PM ET

Chronic Lymphocytic Leukemia (CLL) and Follicular Lymphoma (FL)

• Clinical, biologic and practical factors in the selection of first-line treatment for patients with CLL
• Long-term follow-up from Phase III studies assessing ibrutinib- and acalabrutinib-based therapy for patients with treatment-naïve CLL
• Published results from the Phase III SEQUOIA trial comparing zanubrutinib to bendamustine/rituximab (BR) as first-line therapy for previously untreated CLL
• Implications of the Phase III ELEVATE-RR and ALPINE studies evaluating acalabrutinib and zanubrutinib, respectively, versus ibrutinib for previously treated CLL
• Key data sets informing the optimal use of venetoclax-based therapy for newly diagnosed CLL
• Importance, if any, of minimal residual disease (MRD) assessment in determining the duration of venetoclax-based up-front therapy; current and future roles of MRD in clinical decision-making
• Results from and clinical implications of the Phase III GLOW trial evaluating first-line ibrutinib in combination with venetoclax
• Ongoing trials evaluating other novel combination regimens with Bruton tyrosine kinase (BTK) and Bcl-2 inhibitors
• Pharmacologic similarities and differences between the investigational noncovalent BTK inhibitor pirtobrutinib and covalent BTK inhibitors; implications for efficacy and tolerability
• Updated results for patients with relapsed/refractory (R/R) CLL in the BRUIN study of pirtobrutinib; potential clinical role
• Available data with, ongoing investigation of and potential role for CD19-directed chimeric antigen receptor (CAR) T-cell therapy for R/R CLL
• Long-term clinical trial findings with lenalidomide/rituximab for treatment-naïve and R/R FL; current role in practice
• Key findings from the Phase III CHRONOS-3 trial evaluating copanlisib with rituximab for R/R FL
• Incidence of EZH2 mutations in patients with FL; key findings with and optimal use of tazemetostat for R/R FL with and without EZH2 mutations
• Principal outcomes from pivotal studies (eg, ZUMA-5, ELARA) evaluating CAR T-cell therapy for FL
• FDA approvals of axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tis-cel) for R/R FL; current roles in clinical practice
• Rationale for the evaluation of CD20 x CD3 bispecific antibodies for FL
• Published findings with mosunetuzumab for R/R FL; FDA priority review status and potential clinical role
• Available research with other bispecific antibodies under development for FL (eg, glofitamab, epcoritamab)

Diffuse Large B-Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Mantle Cell Lymphoma (MCL)

• Published results from the Phase III POLARIX study comparing polatuzumab vedotin in combination with chemotherapy to R-CHOP for previously untreated DLBCL; implications for clinical practice
• Key findings with polatuzumab vedotin in combination with BR for R/R DLBCL
• Efficacy and safety outcomes with tafasitamab/lenalidomide for patients with R/R DLBCL
• Mechanism of action of and available data with loncastuximab tesirine for R/R DLBCL
• Long-term data with axi-cel, tis-cel or lisocabtagene maraleucel (liso-cel) for multiregimen-relapsed DLBCL
• Results from key studies evaluating CAR T-cell therapy as second-line treatment for DLBCL; recent FDA approval of axi-cel and liso-cel in this setting
• Emerging results with other CAR T-cell platforms (eg, rapcabtagene autoleucel) for DLBCL
• Molecular configurations of different CD20 x CD3 bispecific antibodies in development; implications for activity and tolerability
• Recently presented outcomes with glofitamab and with epcoritamab for R/R DLBCL; potential clinical roles
• Long-term follow-up, including overall survival findings, from the Phase III ECHELON-1 trial of first-line brentuximab vedotin (BV) with AVD (doxorubicin/vinblastine/dacarbazine) for advanced classical HL
• Early findings with BV combined with chemotherapy for early-stage unfavorable-risk HL
• 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
• Biologic rationale for the investigation of antibody-drug conjugates with alternative targets in HL; mechanism of action and structural components of camidanlumab tesirine
• Principal efficacy and safety findings from the pivotal Phase II study of camidanlumab tesirine for heavily pretreated HL; potential role in practice
• Research database supporting the FDA approvals of ibrutinib, acalabrutinib and zanubrutinib for R/R MCL; key factors in choosing a BTK inhibitor
• Available (SHINE trial) and emerging (TRIANGLE trial) Phase III data sets evaluating ibrutinib-based therapy for newly diagnosed MCL
• Early data with other BTK inhibitor-based combination regimens for previously untreated MCL
• Efficacy and safety findings from the Phase I/II BRUIN study of pirtobrutinib for R/R MCL
• Early-phase research with venetoclax alone or combined with other agents for MCL
• Clinical research findings with brexucabtagene autoleucel and optimal integration into MCL treatment algorithms
• Ongoing assessment of other CAR T-cell platforms (eg, liso-cel) for MCL

Module 5
Gynecologic Cancers | 2:05 PM – 3:05 PM ET

Ovarian Cancer (OC)

• Incidence of germline and somatic BRCA mutations and homologous recombination deficiency in patients with advanced OC; indications and optimal platforms for genetic testing
• Long-term efficacy and safety findings, including overall survival outcomes, from the Phase III SOLO-1 and PAOLA-1 studies of olaparib and olaparib/bevacizumab, respectively, as maintenance therapy for newly diagnosed advanced OC
• Key efficacy and safety data from the Phase III PRIMA and PRIME studies supporting the use of first-line maintenance niraparib
• Optimal integration of up-front maintenance therapy with PARP inhibitors; use of clinical characteristics and other factors to select among olaparib, olaparib/bevacizumab and niraparib
• Recently presented efficacy and safety data from the Phase III ATHENA-MONO study assessing rucaparib as first-line maintenance therapy; impact of recent FDA actions on the developmental timeline for up-front maintenance rucaparib
• Findings from the Phase II OVARIO study assessing maintenance therapy with niraparib/bevacizumab after front-line platinum-based chemotherapy/bevacizumab for advanced OC; potential clinical role
• Long-term follow-up from pivotal trials evaluating niraparib, olaparib and rucaparib for platinum-sensitive and platinum-resistant recurrent OC; rationale for the voluntary withdrawal of various indications for approved PARP inhibitors
• Key findings from the Phase IIIb OReO study evaluating the clinical utility of rechallenge with a PARP inhibitor for patients who have experienced disease progression on or after PARP inhibitor therapy; implications for later-line treatment
• Biologic rationale for combining PARP inhibitors with anti-PD-1/PD-L1 antibodies with or without bevacizumab for OC; results from early-phase studies (eg, MEDIOLA, TOPACIO, OPAL, MOONSTONE)
• Ongoing Phase III trials evaluating PARP inhibitors in combination with immune checkpoint inhibitors for advanced OC (eg, ATHENA-COMBO, FIRST, DUO-O)
• Biologic rationale for targeting folate receptor alpha in OC; mechanism of action of mirvetuximab soravtansine
• Published efficacy and safety outcomes from the Phase III SORAYA study of mirvetuximab soravtansine for patients with platinum-resistant OC and high folate receptor alpha expression
• Recent FDA approval of mirvetuximab soravtansine; implications for biomarker assessment and current management
• Spectrum, frequency and management of toxicities, including ocular events, associated with mirvetuximab soravtansine
• Ongoing trials evaluating mirvetuximab soravtansine for advanced OC (eg, MIRASOL, PICCOLO, GLORIOSA)
• Rationale for targeting NaPi2b in OC; mechanism of antitumor activity and structural components of upifitamab rilsodotin (UpRi)
• Clinical research documenting the efficacy and safety of UpRi for pretreated, advanced OC; ongoing trials for platinum-sensitive and platinum-resistant disease (eg, UPLIFT, UP-NEXT, UPGRADE)
• Mechanism of action of tumor treating fields and biologic rationale for their use in combination with chemotherapy for platinum-resistant OC
• Early-phase efficacy and safety data with tumor treating fields in combination with chemotherapy for advanced OC; ongoing Phase III INNOVATE-3 study

Endometrial Cancer (EC) and Cervical Cancer (CC)

• Incidence of microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) advanced EC; appropriate methods and timing for testing
• Long-term data with dostarlimab or pembrolizumab monotherapy for MSI-H/dMMR advanced EC; likelihood, rapidity and durability of responses
• Current indications for and optimal integration of dostarlimab and pembrolizumab monotherapy into the care of patients with MSI-H/dMMR advanced EC
• Available clinical trial data with anti-PD-1/PD-L1 antibodies as monotherapy in patients with microsatellite-stable/mismatch repair-proficient EC
• Biologic rationale for combining immune checkpoint inhibitors with agents targeting the VEGF pathway for EC
• Long-term efficacy and safety findings from the Phase III KEYNOTE-775 trial comparing lenvatinib/pembrolizumab to chemotherapy for patients with advanced EC previously treated with a platinum-based regimen
• FDA approval of and patient selection for lenvatinib/pembrolizumab
• Incidence and severity of toxicities associated with lenvatinib/pembrolizumab; monitoring and management strategies
• Design, eligibility criteria, primary and secondary endpoints and anticipated completion date of the Phase III LEAP-001 trial evaluating lenvatinib/pembrolizumab as first-line treatment for advanced EC
• Ongoing Phase III trials evaluating paclitaxel/carboplatin with or without anti-PD-1/PD-L1 antibody therapy for recurrent or primary advanced EC (eg, RUBY, AtTEnd, DUO-E)
• Mechanism of action of selinexor and biologic rationale for its evaluation for EC
• Key efficacy and safety data from the Phase III SIENDO trial evaluating selinexor versus placebo as maintenance after first-line chemotherapy for advanced EC; potential role of selinexor as front-line maintenance therapy
• Major findings from the Phase III KEYNOTE-826 trial of pembrolizumab in combination with platinum-based chemotherapy with or without bevacizumab as up-front therapy for advanced CC
• Optimal integration of first-line pembrolizumab/chemotherapy into the care of patients with CC
• Available data with anti-PD-1/PD-L1 antibodies as monotherapy for progressive advanced CC
• Ongoing trials evaluating anti-PD-1/PD-L1 antibodies in combination with chemotherapy, chemoradiation therapy or anti-CTLA-4 antibodies for locally advanced or metastatic CC
• Rationale for targeting tissue factor in CC; mechanism of action and structural components of tisotumab vedotin
• Key efficacy outcomes observed with tisotumab vedotin in patients with recurrent metastatic CC who experience disease progression after chemotherapy; optimal integration into clinical care
• Frequently observed toxicities with tisotumab vedotin; recommended algorithms for the prevention and management of ocular and other adverse events
• Early data with and ongoing evaluation of tisotumab vedotin in combination with other anticancer therapies (eg, chemotherapy, pembrolizumab) for metastatic CC

Afternoon Break | 3:05 PM – 3:20 PM ET

Module 6
Lung Cancer | 3:20 PM – 4:20 PM ET

Targeted Therapy

• Patient selection for adjuvant osimertinib and appropriate incorporation into routine practice on the basis of findings from the Phase III ADAURA trial
• Optimal first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) with EGFR tumor mutations, including those with CNS metastases
• Spectrum and clinical relevance of resistance mechanisms in patients experiencing disease progression on osimertinib
• Patritumab deruxtecan for metastatic, EGFR tyrosine kinase inhibitor-resistant NSCLC: Mechanism of action, available data and ongoing evaluation
• Activity and tolerability of amivantamab and lazertinib in the CHRYSALIS-2 trial for patients with NSCLC with EGFR mutations after disease progression on osimertinib and platinum-based chemotherapy
• Key efficacy and safety data informing the FDA approvals of mobocertinib and amivantamab for patients with EGFR exon 20 insertion mutations who have experienced disease progression on first-line chemotherapy
• Evidence-based selection and sequencing of mobocertinib and amivantamab for NSCLC with EGFR exon 20 mutation
• Factors influencing the selection of a novel ALK inhibitor (eg, alectinib, brigatinib, lorlatinib) as first-line therapy for patients with ALK-rearranged NSCLC
• Selection and sequencing of therapy for patients with progressive ALK-positive NSCLC
• Principal efficacy and safety findings, including intracranial response rates, with entrectinib for ROS1-positive NSCLC; appropriate integration into practice
• Available data with, FDA breakthrough therapy designation for and ongoing evaluation of repotrectinib for NSCLC with ROS1 rearrangements
• Key efficacy and safety outcomes from the Phase II DESTINY-Lung02 study evaluating trastuzumab deruxtecan (T-DXd) for NSCLC with HER2 mutation or overexpression
• Recent FDA approval of T-DXd for NSCLC with HER2 mutation; optimal incorporation into practice
• Principal efficacy and safety findings with sotorasib for pretreated KRAS G12C-mutated NSCLC; recent FDA approval and current role in patient care
• Key data with adagrasib for previously treated KRAS G12C-mutated disease; potential clinical role of this agent
• Antitumor activity observed with selpercatinib and with pralsetinib in patients with RET fusion-driven advanced NSCLC, including those with previously untreated disease
• Optimal integration of and selection between selpercatinib and pralsetinib in therapy for metastatic NSCLC with RET fusion
• Key findings with capmatinib and tepotinib for NSCLC with MET exon 14 mutation
• Role of capmatinib and tepotinib in current clinical practice; individualized selection between these agents

Immunotherapeutic and Other Novel Strategies

• Key findings from the Phase III CheckMate 816 trial evaluating nivolumab in combination with chemotherapy as neoadjuvant therapy for resectable Stage IB to IIIA NSCLC; selection of appropriate patients for this strategy
• Emerging data from the Phase III AEGEAN study demonstrating an improvement in pathologic complete response rate with durvalumab added to neoadjuvant chemotherapy compared to chemotherapy alone for resectable NSCLC
• Design, eligibility criteria and published efficacy and safety findings from the Phase III IMpower010 trial evaluating atezolizumab versus best supportive care after adjuvant chemotherapy for completely resected NSCLC; FDA approval and current role of adjuvant atezolizumab
• Available data from the Phase III PEARLS/KEYNOTE-091 study of pembrolizumab as adjuvant therapy for Stage IB to IIIA NSCLC
• Long-term findings from the Phase III PACIFIC trial evaluating consolidation durvalumab after chemoradiation therapy for patients with unresectable Stage III NSCLC
• Key factors affecting the selection of anti-PD-1/PD-L1 monotherapy, combined chemoimmunotherapy or dual immune checkpoint inhibition for newly diagnosed metastatic NSCLC without a targetable tumor mutation
• Clinical trial data supporting the FDA approvals of pembrolizumab, atezolizumab and cemiplimab administered as monotherapy for the first-line treatment of metastatic NSCLC
• Documented antitumor activity and safety of anti-PD-1/PD-L1 monotherapy in patients with poor performance status
• Emerging results demonstrating the noninferiority of subcutaneous atezolizumab compared to standard intravenous therapy for patients with advanced NSCLC; implications for practice
• Results from the Phase III EMPOWER-Lung 3 study of cemiplimab in combination with platinum-based chemotherapy as first-line therapy for NSCLC; recent FDA approval and current clinical role
• Phase III results with first-line nivolumab/ipilimumab with and without chemotherapy in the CheckMate 227 and CheckMate 9LA trials; patient selection and optimal integration into practice
• Design, eligibility criteria and key findings from the Phase III POSEIDON trial evaluating durvalumab or durvalumab and tremelimumab in combination with platinum-based chemotherapy as first-line therapy for metastatic NSCLC
• Recent FDA approval of durvalumab/tremelimumab/chemotherapy and current role of this combination in clinical practice
• Biologic rationale for targeting TROP2 in NSCLC
• Datopotamab deruxtecan for progressive metastatic disease: Mechanism of action, available data and ongoing investigation
• Biologic justification for targeting CEACAM5 in NSCLC
• Tusamitamab ravtansine for advanced nonsquamous NSCLC: Mechanism of antitumor activity, early efficacy and safety data and ongoing evaluation

Closing Remarks | 4:20 PM – 4:30 PM ET

MEETING ADJOURNS | 4:30 PM ET