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

Faculty

Faculty

Andrea Cercek

MD

Memorial Sloan Kettering Cancer Center, New York, New York

Section Head, Colorectal Cancer, Co-Director, Center for Young Onset Colorectal and Gastrointestinal Cancers, Attending, Gastrointestinal Oncology Service, Department of Medicine

Faculty

Arvind Dasari

MD, MS

The University of Texas MD Anderson Cancer Center, Houston, Texas

Professor, Department of Gastrointestinal Medical Oncology

Moderator

Tanios Bekaii-Saab

MD

Mayo Clinic Comprehensive Cancer Center (All Sites)

David F and Margaret T Grohne Professor of Novel Therapeutics for Cancer Research I, Chair and Consultant, Division of Hematology and Medical Oncology, Co-Leader, Advanced Clinical and Translational Science Program

Mayo Clinic in Arizona, Phoenix, Arizona

Professor, Mayo Clinic College of Medicine and Science

Program Schedule — Central Time
6:00 PM – 6:30 PM — Registration and Dinner
6:30 PM – 8:00 PM — Educational Meeting

MODULE 1: Current and Future Role of Immune Checkpoint Inhibition in the Management of Microsatellite Instability-High (MSI-H)/Mismatch Repair-Deficient (dMMR) Localized and Locally Advanced Colorectal Cancer (CRC)

• Current role of neoadjuvant and adjuvant systemic treatment in localized/locally advanced rectal and colon tumors; historical outcomes achieved with chemotherapy and chemoradiation therapy for patients with MSI-H/dMMR disease
• Updated results with dostarlimab as an alternative to surgery for MSI-H/dMMR locally advanced rectal cancer; implications for organ preservation
• FDA breakthrough therapy designation for dostarlimab for patients with locally advanced MSI-H/dMMR rectal cancer; ongoing evaluation in the registrational Phase II AZUR-1 trial
• Early-phase data with neoadjuvant anti-PD-1/PD-L1 antibodies alone or in combination with other immunotherapies for patients with nonmetastatic MSI-H/dMMR colon cancer; ongoing Phase III AZUR-2 study of perioperative dostarlimab in this population
• Design, eligibility criteria and key efficacy and safety findings from the Phase III Alliance A021502/ATOMIC trial assessing atezolizumab in combination with mFOLFOX6 and continued as monotherapy in the adjuvant setting for patients with Stage III CRC and dMMR tumors
• Patient selection for and potential role of adjuvant atezolizumab for patients with Stage III CRC

MODULE 2: Clinical Relevance and Practical Use of Molecular Residual Disease (MRD) Analysis in CRC

• Biological rationale for circulating tumor DNA (ctDNA)-based MRD monitoring in CRC; benefits of ctDNA monitoring over traditional means of follow-up
• Published datasets (eg, the CIRCULATE-Japan and BESPOKE CRC trials) evaluating the use of ctDNA testing to identify patients at increased risk of recurrence
• Recent findings from various studies (eg, the DYNAMIC, CALGB/SWOG-80702, ALTAIR and ALASCCA trials) attempting to validate the use of ctDNA testing in predicting benefit from adjuvant treatment regimens
• Ongoing Phase III trials examining the clinical utility of ctDNA-based MRD testing for guiding treatment decision-making in localized CRC
• Available evidence supporting the use of ctDNA as a tool for monitoring for recurrence after curative-intent therapy; recommended timing and frequency of ctDNA testing in the surveillance setting
• Current and potential future role of ctDNA testing in localized, locally advanced and metastatic CRC

MODULE 3: Recent Advances in Metastatic CRC (mCRC) — Optimizing Immunotherapy and Other Approaches

• Rationale for the evaluation of dual immune checkpoint inhibition for newly diagnosed mCRC
• Design, eligibility criteria and key endpoints of the Phase III CheckMate 8HW trial assessing nivolumab/ipilimumab versus chemotherapy with or without bevacizumab or cetuximab for previously untreated MSI-H/dMMR mCRC
• Key efficacy and safety findings from the CheckMate 8HW trial assessing nivolumab/ipilimumab versus chemotherapy with or without bevacizumab or cetuximab for previously untreated MSI-H/dMMR mCRC; FDA approval and current role of nivolumab/ipilimumab in first-line therapy
• Biological rationale for dual targeting of EGFR and MET with amivantamab for patients with mCRC
• Available efficacy and safety findings from the Phase Ib/II OrigAMI-1 trial evaluating amivantamab as monotherapy and in combination with chemotherapy for patients with mCRC
• Design, eligibility criteria and primary and secondary endpoints of the Phase III OrigAMI-2 and OrigAMI-3 trials evaluating subcutaneous amivantamab with FOLFOX and FOLFIRI; potential clinical role of amivantamab in therapy for patients with mCRC
• Available data with immune checkpoint inhibitors alone and in combination with other agents for patients with microsatellite-stable (MSS)/mismatch repair-proficient (pMMR) mCRC
• Mechanistic similarities and differences between zanzalintinib and other multikinase inhibitors for CRC; rationale for combining zanzalintinib with an anti-PD-1/PD-L1 antibody in therapy for mCRC
• Recently presented efficacy and safety findings from the Phase III STELLAR-303 trial evaluating zanzalintinib with atezolizumab for pretreated MSS/pMMR mCRC; implications for therapeutic sequencing
• Future development plans for zanzalintinib/atezolizumab in the management of CRC and implications for therapeutic sequencing
• Available data with and optimal use of targeted therapy for patients with mCRC and a BRAF, HER2 or KRAS G12C mutation

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

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

• Understand validated biomarkers of response (eg, RAS mutations, microsatellite instability (MSI)/mismatch repair (MMR) deficiency, HER2 overexpression, BRAF V600E mutations, KRAS G12C mutations) found in patients with CRC, and consider the implications for molecular testing and clinical care.
• Evaluate the biological rationale for the use of immune checkpoint inhibitors in the management of MSI-high (MSI-H)/mismatch repair-deficient (dMMR) localized and advanced CRC, and counsel patients regarding evidence-based and guideline-endorsed treatment recommendations.
• Optimize the current and future use of neoadjuvant and adjuvant therapy for patients with localized and locally advanced CRC, considering the influence of various clinical and biological factors such as MSI-H/dMMR status.
• Recognize the clinical relevance of circulating tumor DNA (ctDNA) as a prognostic and predictive biomarker in CRC, and comprehend the rationale for its use in detecting molecular residual disease.
• Appreciate published datasets documenting the clinical utility of ctDNA testing in risk stratification, surveillance and treatment decision-making for patients with CRC, and consider the current and future role of this strategy in personalizing therapeutic recommendations.
• Formulate a plan to guide the selection and sequencing of therapies for patients diagnosed with metastatic CRC (mCRC) accounting for tumor sidedness, biomarker profile, prior systemic therapy, symptomatology and personal goals of treatment.
• Appreciate published research documenting the efficacy of targeted therapeutic approaches for patients with mCRC and various actionable genomic alterations in order to personalize treatment recommendations.
• Recall ongoing trials evaluating novel agents and strategies for patients with mCRC, and use this information to refer candidates for study participation.

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

Accreditation Statement
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) 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 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Privacy Policy
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.

Unlabeled/Unapproved Uses Notice
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the provider or grantors.

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 financial relationships 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. Financial disclosures will be provided.

FACULTY
To be announced.

MODERATOR
To be announced.

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 Exelixis Inc, GSK, and Natera Inc.

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.