All events moderated by
Neil Love, MD
Research To Practice
Miami, Florida

Monday, January 11, 2021 from 5:00 PM – 6:00 PM Eastern Time

Monday, February 22, 2021 from 5:00 PM – 6:00 PM Eastern Time

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Eisai Inc, Genentech, a member of the Roche Group, and Merck.

Topics to Be Discussed

MODULE 1: Optimal Integration of Immune Checkpoint Inhibitors into the Management of Metastatic Triple-Negative Breast Cancer (mTNBC)

• Long-term efficacy and safety findings from the Phase III IMpassion130 trial evaluating atezolizumab/nab paclitaxel as first-line therapy for mTNBC
• Primary results from the Phase III IMpassion131 study of first-line paclitaxel with or without atezolizumab for mTNBC; recent FDA alert regarding efficacy and safety concerns with this combination
• Design, eligibility criteria and key efficacy and safety findings from the Phase III KEYNOTE-355 trial evaluating chemotherapy with or without pembrolizumab for patients with previously untreated mTNBC
• FDA approvals of atezolizumab/nab paclitaxel and pembrolizumab/chemotherapy for patients with PD-L1-positive mTNBC; optimal integration into practice
• Current indications and optimal testing platforms for assessing PD-L1 expression in patients with mTNBC
• Other novel combination immunotherapeutic strategies under investigation for patients with mTNBC

MODULE 2: Novel Applications of Immune Checkpoint Inhibitors for Patients with Early TNBC

• Clinical and biologic rationale for the investigation of immune checkpoint blockade in localized BC
• Available results from the Phase III KEYNOTE-522 trial documenting the benefit of neoadjuvant pembrolizumab with chemotherapy versus chemotherapy alone for TNBC
• Design, eligibility criteria and key efficacy and safety findings from the Phase III IMpassion031 study evaluating the addition of atezolizumab to nab paclitaxel followed by doxorubicin and cyclophosphamide as neoadjuvant treatment for early-stage TNBC
• Effect of PD-L1 status on outcomes in KEYNOTE-522 and IMpassion031
• Current nonresearch role, if any, of neoadjuvant immune checkpoint inhibition for patients with TNBC
• Ongoing randomized Phase III clinical trials evaluating anti-PD-1/PD-L1 antibodies with chemotherapy for patients with localized TNBC (eg, IMpassion030, SWOG-S1418)

MODULE 3: Current and Future Role of PARP Inhibitors for Patients with TNBC and a BRCA Mutation

• Phase III data sets supporting the FDA approvals of olaparib (OlympiAD) and talazoparib (EMBRACA) for patients with mBC and a germline BRCA mutation; optimal integration into current management algorithms
• Key findings from the Phase II TBCRC 048 study of olaparib monotherapy for patients with mBC with germline or somatic mutations in DNA damage response pathway genes beyond germline BRCA1/2
• Recommended genetic testing algorithms and patient selection for PARP inhibition in routine general medical oncology practice
• Comparative incidence of side effects (eg, gastrointestinal toxicities, alopecia, anemia, thrombocytopenia) associated with olaparib and talazoparib; optimal prevention and management strategies
• Available efficacy and safety results from studies attempting to combine veliparib with platinum-based chemotherapy (eg, BROCADE 3, SWOG-S1416) for mBC
• Biologic rationale for the investigation of PARP inhibitors combined with immune checkpoint inhibitors; early results and ongoing studies
• Available data with and ongoing investigation of PARP inhibition in the adjuvant and neoadjuvant settings

MODULE 4: Current and Future Management of PD-L1-Negative mTNBC

• Historical efficacy and safety outcomes with available therapies (capecitabine, eribulin, gemcitabine, platinums) for advanced TNBC; optimal selection and sequencing of these agents for patients who are not candidates for biomarker-based therapy
• Mechanism of action of, available data with and FDA approval of sacituzumab govitecan; optimal integration into current TNBC management algorithms
• Design, eligibility criteria and key efficacy and safety findings from the Phase III ASCENT trial comparing sacituzumab govitecan to physician’s choice chemotherapy for relapsed/refractory TNBC
• Rationale for targeting the PI3K/AKT/mTOR pathway in TNBC; available data with and ongoing investigation of ipatasertib in combination with paclitaxel for mTNBC
• Other promising novel agents and strategies under investigation in this disease subset

Target Audience
These activities are intended for medical oncologists, breast cancer surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer.

Learning Objectives
At the conclusion of the activity, participants should be able to

• Appreciate the biologic rationale for, available data with and potential long-term benefits of anti-PD-1/PD-L1 antibody therapy for patients with metastatic triple-negative breast cancer (TNBC).
• Review available research data supporting the use of chemotherapy in combination with anti-PD-1/PD-L1 antibodies for newly diagnosed PD-L1-positive TNBC, and use this information to identify patients who may be appropriate for this approach.
• Evaluate published research findings, clinical factors (eg, age, performance status, prior therapeutic exposure) and patient preferences in 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.
• Consider available research data and ongoing clinical trials evaluating anti-PD-1/PD-L1 antibodies for patients with localized TNBC, and consider the potential role of these strategies in clinical practice.
• Assess the biologic rationale for ongoing clinical trials evaluating anti-PD-1/PD-L1 antibodies alone or in combination with other systemic therapies for breast cancer, in order to effectively communicate the potential benefits of trial participation to patients.
• 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.
• Recall the design of ongoing clinical trials evaluating other investigational PARP inhibitors and novel applications of PARP inhibitors alone or in combination with other systemic approaches (eg, immunotherapy, chemotherapy) for breast cancer, and counsel appropriate patients about availability and participation.
• Consider the mechanisms of action of, early data with and ongoing research evaluating other novel agents and treatment strategies under development for TNBC.

CME Credit Form
A CME credit form will be emailed to participants within 3 business 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 each live activity for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Content Validation and Disclosures
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 (and their spouses/partners) reported relevant conflicts of interest, which have been resolved through a conflict of interest resolution process:

Dr Marcom — Advisory Committee: Immunomedics Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, GlycoMimetics Inc, Novartis, Takeda Oncology, Verily; Data and Safety Monitoring Board/Committee: Genentech, a member of the Roche Group. Dr O’Shaughnessy — Advisory Committee and Consulting Agreements: AbbVie Inc, Agendia Inc, Amgen Inc, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Celgene Corporation, Eisai Inc, Exact Sciences Inc, Genentech, a member of the Roche Group, Grail Inc, Heron Therapeutics, Immunomedics Inc, Ipsen Biopharmaceuticals Inc, Jounce Therapeutics, Lilly, Merck, Myriad Genetic Laboratories Inc, Novartis, Odonate Therapeutics, Pfizer Inc, Puma Biotechnology Inc, Roche Laboratories Inc, Seagen Inc, Syndax Pharmaceuticals Inc; Speakers Bureau: AstraZeneca Pharmaceuticals LP, Lilly, Novartis, Seagen Inc.

MODERATOR — 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 commercial interests: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, Adaptive Biotechnologies Corporation, Agendia Inc, Agios Pharmaceuticals Inc, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Biodesix Inc, bioTheranostics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Eisai Inc, EMD Serono Inc, Epizyme Inc, Exact Sciences Inc, Exelixis Inc, Five Prime Therapeutics Inc, Foundation Medicine, Genentech, a member of the Roche Group, Genmab, Gilead Sciences Inc, GlaxoSmithKline, Grail Inc, Guardant Health, Halozyme Inc, Helsinn Healthcare SA, ImmunoGen Inc, Incyte Corporation, Infinity Pharmaceuticals Inc, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Kite, A Gilead Company, Lexicon Pharmaceuticals Inc, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Merrimack Pharmaceuticals Inc, Myriad Genetic Laboratories Inc, Natera Inc, Novartis, Novocure Inc, Oncopeptides, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Prometheus Laboratories Inc, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Sandoz Inc, a Novartis Division, Sanofi Genzyme, Seagen Inc, Sirtex Medical Ltd, Spectrum Pharmaceuticals Inc, Sumitomo Dainippon Pharma Oncology Inc, Taiho Oncology Inc, Takeda Oncology, Tesaro, A GSK Company, Teva Oncology, Tokai Pharmaceuticals 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.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Eisai Inc, Genentech, a member of the Roche Group, and Merck.