Friday January 19, 2024, San Francisco, California, 6:15 PM – 8:15 PM Pacific Time (9:15 PM – 11:15 PM Eastern Time)
Consensus or Controversy? Clinical Investigators Provide Perspectives on Biomarker Assessment and Related Treatment Decision-Making for Patients with Colorectal Cancer
Part 2 of a 2-Part CME Symposium Series Held in Conjunction with the 2024 ASCO Gastrointestinal Cancers Symposium
Meeting Room
Golden Gate Ballroom — Salon A (B2 Level)
This event will also be webcast live. Please see Registration tab for details.
There is no registration fee for this event. For the in-person symposium in San Francisco, preregistration is required as seating is limited.
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
Chair, ACCRU Research Consortium
Phoenix, Arizona
Andrea Cercek, MD
Section Head, Colorectal Cancer
Co-Director, Center for Young Onset Colorectal
and Gastrointestinal Cancers
Associate Attending
Gastrointestinal Oncology Service
Department of Medicine
Memorial Sloan Kettering Cancer Center
New York, New York
Cathy Eng, MD
Professor of Medicine, Hematology and Oncology
David H Johnson Endowed Chair in Surgical and Medical Oncology
Director for Strategic Relations
Co-Chairman, NCI GI Steering Committee
Co-Director, GI Oncology
Co-Leader, GI Cancer Research Program
Director, Young Adult Cancers Program
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee
John Strickler, MD
Associate Professor
Associate Director, Clinical Research – GI
Duke University
Durham, North Carolina
Moderator Christopher Lieu, MD
Associate Professor of Medicine
Associate Director for Clinical Research
Co-Director, GI Medical Oncology
University of Colorado Cancer Center
Aurora, Colorado
This activity is supported by educational grants from Bristol Myers Squibb, Natera Inc, and Pfizer Inc.
MODULE 1: Optimizing Biomarker Assessment for Patients with Colorectal Cancer (CRC) — Dr Eng
Prevalence, prognostic relevance and therapeutic implications of validated biomarkers of treatment response in patients with metastatic CRC (mCRC) (eg, RAS mutations, BRAF V600E mutations, HER2 overexpression, microsatellite instability [MSI]/mismatch repair [MMR] deficiency)
Guideline-endorsed and evidence-based indications for biomarker analysis in patients with CRC
Benefits and limitations of available assays and testing platforms; optimal selection among various testing modalities and integration into clinical care
Appropriate timing of biomarker assessment; role in the treatment of localized disease compared to newly diagnosed metastatic disease or relapsed/refractory disease (R/R)
Real-world implementation of biomarker analysis for patients with mCRC; current barriers to appropriate testing practices
Published clinical research establishing the correlation between location of the primary tumor and outcomes with specific therapies in patients with mCRC
MODULE 2: Emerging Role of Biomarker-Based Decision-Making for Patients with Localized CRC — Dr Lieu
Biological rationale for and early data (eg, from the NICHE and NICHE-2 trials) with the use of immune checkpoint inhibitors for nonmetastatic CRC
Ongoing Phase III trials evaluating the role of immune checkpoint inhibitors in therapy for nonmetastatic CRC
Benefits and limitations of currently available approaches to surveillance for patients with localized CRC who have undergone curative-intent therapy
Mechanistic rationale for circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) monitoring in the management of localized CRC
Published data sets, such as from the observational GALAXY arm of the CIRCULATE-Japan trial, evaluating the use of ctDNA testing to identify patients at increased risk of recurrence who are likely to benefit from adjuvant chemotherapy
Active studies, such as CIRCULATE-US, BESPOKE CRC, VEGA and ALTAIR, examining the clinical utility of ctDNA-based MRD testing in guiding treatment decision-making and monitoring for recurrence; potential clinical impact
Available data with and potential clinical role of ctDNA testing in molecular characterization and tumor response monitoring for patients with mCRC
MODULE 3: Identification and Clinical Care of Patients with mCRC and a BRAF V600E Mutation — Dr Bekaii-Saab
Similarities and differences between BRAF V600E and non-V600 mutations in mCRC; implications for disease management
Potential clinical or biological factors, such as patient characteristics, tumor sidedness, histology and co-mutations, associated with the presence of BRAF V600 mutations in CRC
Long-term findings from the Phase III BEACON CRC study evaluating encorafenib/cetuximab with or without binimetinib versus standard therapy for patients with mCRC and BRAF V600E mutations
FDA approval and appropriate integration of encorafenib/cetuximab for patients with BRAF V600E-mutated mCRC
Rationale for the evaluation of earlier use of BRAF-targeted therapy; findings from the Phase II ANCHOR CRC trial evaluating encorafenib/binimetinib/cetuximab for patients with treatment-naïve BRAF V600E-mutated mCRC
Design, eligibility criteria and key endpoints of the Phase III BREAKWATER trial comparing encorafenib/cetuximab with or without chemotherapy to standard chemotherapy for patients with previously untreated BRAF V600E-mutated mCRC; safety lead-in results and estimated completion date
MODULE 4: Integration of Immune Checkpoint Inhibitors into the Management of MSI-High/MMR-Deficient mCRC — Dr Cercek
Biological rationale for the efficacy of immune checkpoint inhibitors in patients with MSI-high/MMR-deficient mCRC
Published research data sets establishing the roles of pembrolizumab, nivolumab and nivolumab/ipilimumab for R/R MSI-high/MMR-deficient mCRC
Key efficacy and safety results, including final overall survival findings, from the Phase III KEYNOTE-177 study of front-line pembrolizumab versus chemotherapy for newly diagnosed MSI-high/MMR-deficient mCRC
Design, eligibility criteria and emerging efficacy and safety findings from the Phase III CheckMate 8HW trial evaluating nivolumab/ipilimumab versus chemotherapy for previously untreated MSI-high/MMR-deficient mCRC; implications for therapeutic selection and clinical practice
Key clinical and biological factors potentially influencing the optimal selection of first-line therapy for patients with MSI-high/MMR-deficient mCRC
MODULE 5: HER2 and Other Emerging Biomarkers for Targeted Therapy in mCRC — Dr Strickler
Frequency and clinical relevance of HER2 aberrations among patients with mCRC
Published data from the pivotal Phase II MOUNTAINEER trial evaluating tucatinib/trastuzumab for previously treated HER2-positive mCRC; recent FDA approval and optimal incorporation into practice
Available efficacy and safety findings with trastuzumab deruxtecan for patients with HER2-expressing mCRC (eg, from the DESTINY-CRC01 and DESTINY-CRC02 trials); current and potential nonresearch role
Incidence of KRAS G12C mutations in patients with mCRC; early data with sotorasib and adagrasib monotherapy
Biological rationale for combining KRAS G12C inhibitors with EGFR antibodies
Recently presented results from the Phase III CodeBreaK 300 study evaluating sotorasib with panitumumab versus standard therapy for chemorefractory mCRC with KRAS G12C mutations; implications for clinical practice
Early data with and ongoing evaluations of other targeted strategies for mCRC
Target Audience
This activity is intended for medical oncologists, hematology-oncology fellows, surgeons and other healthcare providers involved in the treatment of gastrointestinal cancers.
Learning Objectives
At the conclusion of this activity, participants should be able to
Develop an understanding of validated biomarkers of response in patients with metastatic colorectal cancer (mCRC), and consider the implications for molecular testing and clinical care.
Assess guideline-endorsed and evidence-based recommendations for biomarker analysis in patients with mCRC, and adapt current testing algorithms based on this information.
Formulate a plan to guide the selection and sequencing of therapies for patients diagnosed with mCRC, considering biomarker profile, prior systemic therapy, symptomatology and personal goals of treatment.
Appreciate published research documenting the efficacy of combined BRAF/EGFR inhibition for patients with relapsed/refractory mCRC and a BRAF V600E mutation, and optimally incorporate this therapeutic strategy into clinical practice.
Evaluate available and emerging data with immune checkpoint inhibitor therapies for microsatellite instability-high or mismatch repair-deficient mCRC, and optimally select patients for treatment with these approaches.
Recognize available data with HER2-targeted therapies for patients with HER2-positive mCRC, and consider the current and future role of FDA-approved and investigational approaches in the treatment of this disease.
Appraise published research establishing the potential benefit of other biomarker-based management approaches, and consider the implications for protocol and nonresearch treatment.
Optimize (neo)adjuvant therapy for patients with localized CRC, considering the influence of various clinical and biological factors (eg, age, performance status, stage, microsatellite instability status) and the potential relevance of molecular residual disease.
CME Credit Form
A CME credit link will be given to each participant at the conclusion 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 2 AMA PRA Category 1 Credits™. 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 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 conflicts of interest 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.
FACULTY — The following faculty reported relevant financial relationships with ineligible entities:
Dr Bekaii-Saab — Consulting Agreements (to Institution): Arcus Biosciences, Bayer HealthCare Pharmaceuticals, Eisai Inc, Genentech, a member of the Roche Group, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Merck, Merck KGaA, Merus BV, Pfizer Inc, Seagen Inc, Servier Pharmaceuticals LLC; Consulting Agreements (to Self): AbbVie Inc, Aptitude Health, AstraZeneca Pharmaceuticals LP, BeiGene Ltd, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Caladrius Biosciences, Celularity, Daiichi Sankyo Inc, Deciphera Pharmaceuticals Inc, Exact Sciences Corporation, Exelixis Inc, Foundation Medicine, GSK, Illumina, Janssen Biotech Inc, Kanaph Therapeutics, Natera Inc, Sanofi, Sobi, Stemline Therapeutics Inc, Treos Bio Ltd, Zai Lab; Data and Safety Monitoring Board/Committee: 1Globe Health Institute, AstraZeneca Pharmaceuticals LP, Eisai Inc, Exelixis Inc, FibroGen Inc, Merck, Suzhou Kintor; Invention/Patent: WO/2018/183488 licensed to Imugene, WO/2019/055687 licensed to Recursion; Research Funding (to Institution): AbGenomics, Agios Pharmaceuticals Inc, Arcus Biosciences, Arrys Therapeutics, a wholly owned subsidiary of Kyn Therapeutics, Atreca, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Celgene Corporation, Clovis Oncology, Eisai Inc, Genentech, a member of the Roche Group, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Lilly, Merus BV, Mirati Therapeutics Inc, Novartis, Pfizer Inc, Seagen Inc, Sumitomo Dainippon Pharma Oncology Inc; Scientific Advisory Board: Artiva Biotherapeutics Inc, Immuneering Corporation, Imugene, Panbela Therapeutics Inc, Replimune, Xilis; Nonrelevant Financial Relationship: MJH Life Sciences, Pancreatic Cancer Action Network, The Valley Hospital, UptoDate. Dr Cercek — Advisory Committee: Bayer HealthCare Pharmaceuticals, GSK, Janssen Biotech Inc, Merck, Pfizer Inc, Roche Laboratories Inc, Seagen Inc; Contracted Research: GSK, Seagen Inc. Dr Eng — Consulting Agreements: Amgen Inc, Elevation Oncology, GE Healthcare, GSK, HOOKIPA Pharma Inc, IGM Biosciences Inc, Merck, Natera Inc, Pfizer Inc, Seagen Inc, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc; Contracted Research (Paid to Vanderbilt): Gritstone bio, Hutchison MediPharma, Janssen Biotech Inc, Merck; Data and Safety Monitoring Board/Committee: Mirati Therapeutics Inc. Dr Strickler — Advisory Committee: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, GSK, Janssen Biotech Inc, Jazz Pharmaceuticals Inc, Lilly, Merck, Natera Inc, Pfizer Inc, Regeneron Pharmaceuticals Inc, Seagen Inc, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, Xilio Therapeutics; Contracted Research: AbbVie Inc, Amgen Inc, AStar D3, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Curegenix, Daiichi Sankyo Inc, Erasca, Genentech, a member of the Roche Group, GSK, Leap Therapeutics Inc, Lilly, Seagen Inc; Data and Safety Monitoring Board/Committee: BeiGene Ltd, Seagen Inc; Stock Options — Private Company: Triumvira Immunologics. Additional faculty disclosures to be announced.
SURVEY PARTICIPANTS Kristen K Ciombor, MD, MSCI — Advisory Committee: Bayer HealthCare Pharmaceuticals, Exelixis Inc, Incyte Corporation, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Personalis, Pfizer Inc, Replimune, Seagen Inc; Consulting Agreements: Merck, Pfizer Inc; Contracted Research: Array BioPharma Inc, a subsidiary of Pfizer Inc, Bristol Myers Squibb, Calithera Biosciences, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Incyte Corporation, Merck, NuCana, Pfizer Inc, Seagen Inc. Arvind Dasari, MD, MS — Advisory Committee: HUTCHMED, Illumina, Personalis, Takeda Pharmaceuticals USA Inc; Contracted Research: Eisai Inc, Enterome, Guardant Health, HUTCHMED, Xencor.
MODERATOR — Christopher Lieu, MD — No relevant conflicts of interest to disclose.
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 Bristol Myers Squibb, Natera Inc, and Pfizer Inc.
San Francisco Marriott Marquis
780 Mission Street
San Francisco, CA 94103
Hotel Phone: (415) 896-1600
Meeting Room
Golden Gate Ballroom — Salon A (B2 Level)
Directions
The San Francisco Marriott Marquis is located just 2 blocks (less than 0.2 miles) from the Moscone Center, where the 2024 ASCO Gastrointestinal Cancers Symposium is taking place.
This activity is intended for medical oncologists, hematology-oncology fellows, surgeons and other healthcare providers involved in the treatment of gastrointestinal cancers.
There is no registration fee for this event. For the in-person symposium in San Francisco, preregistration is required as seating is limited.
NOTICE: Registration for this event is independent of registration for the 2024 ASCO Gastrointestinal Cancers Symposium.
IN-PERSON Registration for clinicians in practice/healthcare professionals
Thank you for your interest in our CME program. At this time online preregistration is closed for this event. SEATS ARE STILL AVAILABLE FOR THIS SESSION. Our onsite registration deskwill be open at 5:45 PM PT on Friday, January 19th. If you are interested in attending, please visit our registration desk outside the Golden Gate Ballroom — Salon A (B2 Level) at the San Francisco Marriott Marquishotel (780 Mission Street), within walking distance of the Moscone Convention Center (2 blocks). Please note: Seats will be offered on a first come, first served basis, and onsite registration does not guarantee participation in the meal service. Clinicians in practice will be prioritized for seating first.
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LIVE WEBCAST Registration for all professionals
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Not an official event of the 2024 ASCO Gastrointestinal Cancers Symposium. Not sponsored, endorsed, or accredited by ASCO®, Association for Clinical Oncology, CancerLinQ®, or Conquer Cancer®, the ASCO Foundation.
