Consensus or Controversy? Documenting and Discussing Investigators’ Approaches to the Management of Ovarian Cancer

Faculty

Faculty

Ramez N Eskander

MD

UC San Diego Health Rebecca and John Moores NCI-Designated Comprehensive Cancer Center San Diego, California

Julie St John Endowed Chair in Gynecologic Oncology Professor, Department of Obstetrics, Gynecology and Reproductive Sciences Clinical Trials Office Medical Director Fellowship Director – Gynecologic Oncology

Faculty

Ursula Matulonis

MD

Harvard Medical School Boston, Massachusetts

Chief, Division of Gynecologic Oncology Brock-Wilson Family Chair Dana-Farber Cancer Institute Professor of Medicine

Faculty

Alexander B Olawaiye

MD

University of Pittsburgh School of Medicine Pittsburgh, Pennsylvania

Professor Department of Obstetrics, Gynecology and Reproductive Sciences

Faculty

David M O'Malley

MD

The Ohio State University and The James Comprehensive Cancer Center, Columbus, Ohio

Director and Professor, Division of Gynecologic Oncology in Obstetrics and Gynecology, John G Boutselis Chair in Gynecologic Oncology

Moderator

Kathleen N Moore

MD, MS

Fred and Pamela Buffett Cancer Center at the University of Nebraska, Omaha, Nebraska

Deputy Director and Director, Phase 1 Clinical Trials

Program Schedule — Central Time
6:30 PM – 7:00 PM — Registration and Dinner
7:00 PM – 9:00 PM — Educational Meeting

MODULE 1: Current Role of PARP Inhibitors in the Management of Advanced Ovarian Cancer (OC)

• Optimal approaches to biomarker testing for patients with newly diagnosed advanced OC; significance of somatic and germline BRCA mutations and homologous recombination deficiency status in treatment decision-making
• Long-term findings, including overall survival (OS) outcomes, with olaparib, olaparib/bevacizumab and niraparib maintenance therapy for patients with newly diagnosed OC
• Clinical, biological and practical factors in the selection of up-front maintenance olaparib, olaparib/bevacizumab or niraparib
• Ongoing Phase III studies, such as MONO-OLA1 and NRG-GY036, further exploring up-front PARP inhibitor maintenance therapy
• Current clinical utility, if any, of PARP inhibitors for patients with relapsed/refractory OC, including those who have experienced disease progression after PARP inhibitor therapy

MODULE 2: Strategies Targeting Folate Receptor Alpha (FRα) in Advanced OC

• Incidence and clinical relevance of FRα expression in OC; optimal approaches to and timing of FRα testing
• Long-term data, including OS findings, with mirvetuximab soravtansine for patients with FRα-positive, platinum-resistant OC from the Phase III MIRASOL trial; optimal integration into current management algorithms
• Key findings from the Phase II PICCOLO trial of mirvetuximab soravtansine for FRα-positive, platinum-sensitive OC; current and potential clinical role
• Design, eligibility criteria and primary and secondary endpoints of the Phase III GLORIOSA trial evaluating mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with FRα-positive OC who have not experienced disease progression after second-line platinum-based chemotherapy and bevacizumab
• Mechanistic similarities and differences between investigational FRα-targeted antibody-drug conjugates, such as rinatabart sesutecan (Rina-S) or AZD5335, and mirvetuximab soravtansine
• Early data with and ongoing evaluation of Rina-S and AZD5335 for FRα-expressing, platinum-resistant OC

MODULE 3: Other Approved and Promising Investigational Antibody-Drug Conjugates for Advanced OC

• Frequency of HER2 expression in advanced OC; outcomes observed among patients with OC in the Phase II DESTINY-PanTumor02 trial of trastuzumab deruxtecan (T-DXd) for pretreated HER2-expressing solid tumors
• Recent tumor-agnostic FDA approval of T-DXd and implications for OC management
• Ongoing Phase III DESTINY-Ovarian01 trial seeking to further define the role of T-DXd in therapy for advanced OC
• Rationale for targeting CDH6 in advanced OC; mechanism of antitumor activity of raludotatug deruxtecan (R-DXd)
• Available research findings, including those from the Phase II dose-optimization part of the ongoing Phase II/III REJOICE-Ovarian01 study, with R-DXd for patients with platinum-resistant advanced OC
• FDA breakthrough therapy designation of R-DXd for patients with platinum-resistant epithelial OC expressing CDH6 who have received prior treatment with bevacizumab; potential clinical role
• Early efficacy and safety outcomes with and ongoing evaluation of TROP2-directed antibody-drug conjugates for patients with advanced OC

MODULE 4: Promising Novel Agents and Strategies Nearing the Clinic for Advanced OC

• Mechanism of antitumor activity of the selective glucocorticoid receptor modulator relacorilant and rationale for its evaluation for advanced OC
• Published efficacy and safety findings from the Phase III ROSELLA study of relacorilant and nab paclitaxel versus nab paclitaxel alone for patients with platinum-resistant advanced OC
• Tolerability profile of relacorilant/nab paclitaxel in the ROSELLA trial; relative contributions of each agent with regard to toxicities
• Recent FDA approval of relacorilant/nab paclitaxel for platinum-resistant advanced OC; integration into current clinical algorithms
• Available and emerging data, including OS outcomes, from the Phase III KEYNOTE-B96 study evaluating the addition of pembrolizumab to chemotherapy with or without bevacizumab for patients with platinum-resistant recurrent OC
• Potential clinical role of pembrolizumab in therapy for platinum-resistant recurrent OC

MODULE 5: Diagnosis and Management of Adverse Events Associated with Common Therapies for Advanced OC

• Spectrum, incidence and severity of common class- and agent-specific toxicities associated with PARP inhibitors for OC
• Optimal monitoring, mitigation and management approaches for common PARP inhibitor-related toxicities
• Reported risk of long-term, serious side effects, such as myelodysplastic syndromes or acute myeloid leukemia, with PARP inhibitor therapy
• Pathogenesis and incidence of ocular adverse reactions associated with mirvetuximab soravtansine; recommended approaches to prevention, monitoring and management
• Spectrum, frequency, severity and management of other side effects, such as peripheral neuropathy, gastrointestinal (GI) toxicities, fatigue and pneumonitis, in patients receiving mirvetuximab soravtansine
• Spectrum and incidence of common (eg, GI toxicities, myelosuppression) and more serious (eg, interstitial lung disease, cardiac toxicities) treatment-emergent adverse events observed with T-DXd
• Recommended strategies to monitor for, mitigate and manage T-DXd-associated toxicities

Target Audience
This activity is intended for medical and gynecologic oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of ovarian cancer.

Learning Objectives
Upon completion of this activity, participants should be able to 

• Understand available clinical research findings with PARP inhibitors as maintenance therapy after first-line platinum-based chemotherapy for advanced OC, and appropriately counsel patients regarding personalized treatment recommendations.
• Appraise biological and patient- and treatment-related factors in order to individualize the selection and sequencing of therapy for platinum-sensitive and platinum-resistant recurrent OC.
• Recognize the rationale for targeting folate receptor alpha (FRα) in OC, and understand the mechanism of action of and available research findings with FRα-directed antibody-drug conjugates (ADCs).
• Appreciate available clinical research findings with anti-PD-1/PD-L1 antibodies in combination with chemotherapy for patients with platinum-resistant OC, and consider the current role of this novel therapeutic strategy.
• Understand the biological justification for the evaluation of selective glucocorticoid receptor modulators in combination with chemotherapy for patients with platinum-resistant OC, and recall available Phase III findings with this novel approach.
• Assess the incidence of cadherin-6 expression in OC, and understand the structural components of, mechanism of action of and available data with novel ADCs directed at this target.
• Review published clinical research findings documenting the efficacy of HER2-targeted agents and regimens in patients with HER2-overexpressing OC and other gynecologic cancers, and consider the role of ADCs and other approaches.
• Describe the scientific justification for, published research data with and current research studies of novel agents and strategies in OC, and effectively prioritize clinical trial opportunities for eligible patients.

CME Credit Form
A CME credit link will be given to each participant as part of the meeting course materials.

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FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Dr Matulonis — Advisory Committees: AbbVie Inc, Ascendis Pharma, Corcept Therapeutics Inc, Day One Biopharmaceuticals, GSK, Kaida BioPharma, Merck, NextCure, Whitehawk Therapeutics; Data and Safety Monitoring Boards/Committees: AstraZeneca Pharmaceuticals LP, MacroGenics Inc, Mural Oncology Inc, Symphogen A/S. Dr O’Malley — Consulting Agreements — Personal Fees (Consult and/or Advisory Boards): AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeOne, Corcept Therapeutics Inc, Daiichi Sankyo Inc, Duality Biologics, Genmab US Inc, GSK, Lilly, Merck, MSD, Novocure Inc, Pfizer Inc, Regeneron Pharmaceuticals Inc, Verastem Inc, Zentalis Pharmaceuticals; Contracted Research (Institution Received Funds for Research): AbbVie Inc, Advaxis Inc, Agenus Inc, Alkermes, Aravive Inc, Arcus Biosciences, AstraZeneca Pharmaceuticals LP, BeOne, Bristol Myers Squibb, Deciphera Pharmaceuticals Inc, Eisai Inc, EMD Serono Inc, Exelixis Inc, F Hoffmann-La Roche Ltd, Genentech, a member of the Roche Group, Genmab US Inc, GSK, ImmunoGen Inc, Incyte Corporation, Iovance Biotherapeutics, Karyopharm Therapeutics, Leap Therapeutics Inc, Merck, Mersana Therapeutics Inc, MSD, Novartis, Novocure Inc, OncoC4, OncoQuest Inc, Pfizer Inc, pharmaand GmbH, Predictive Oncology Inc, Prelude Therapeutics, Regeneron Pharmaceuticals Inc, Seagen Inc, Sumitomo Pharma America, Sutro Biopharma, Tesaro, A GSK Company, Verastem Inc; Data and Safety Monitoring Boards/Committees: Frantz Viral Therapeutics. Dr Olawaiye — Advisory Committees: AstraZeneca Pharmaceuticals LP, Corcept Therapeutics Inc, Daiichi Sankyo Inc, Eisai Inc, GSK, Lilly, Merck; Consulting Agreements: Corcept Therapeutics Inc; Speakers Bureaus: Foundation Medicine. Additional faculty to be announced.

MODERATOR — Dr Moore — Advisory Committees: AstraZeneca Pharmaceuticals LP, Corcept Therapeutics Inc, GSK, Mersana Therapeutics Inc; Consulting Agreements: Aadi Bioscience, AbbVie Inc, AstraZeneca Pharmaceuticals LP, BioNTech SE, Caris Life Sciences, Corcept Therapeutics Inc, Daiichi Sankyo Inc, Duality Biologics, GSK, ImmunoGen Inc, Janssen Biotech Inc, Merck, Regeneron Pharmaceuticals Inc, Schrödinger, Takeda Pharmaceuticals USA Inc, Verastem Inc, Whitehawk Therapeutics, Zentalis Pharmaceuticals, Zymeworks Inc; Contracted Research: Accent Therapeutics, Advaxis Inc, Allarity Therapeutics, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, GSK, Immunocore, Iovance Biotherapeutics, Regeneron Pharmaceuticals Inc, Schrödinger, Verastem Inc; Data and Safety Monitoring Boards/Committees: Bicycle Therapeutics; Nonrelevant Financial Relationships: ASCO, GOG Partners, NRG Oncology.

EDITOR — Dr 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: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS
Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

Supporters
This activity is supported by educational grants from AbbVie Inc, AstraZeneca Pharmaceuticals LP, Corcept Therapeutics Inc, and Merck.

Hilton Chicago
720 South Michigan Avenue
Chicago, IL 60605
Phone: (312) 922-4400

Meeting Room
Continental Room C (Lobby Level)

Directions
The Hilton Chicago hotel is located just 5 minutes (2.5 miles) north of the McCormick Place convention center, where the ASCO Annual Meeting is taking place.