addressing lung cancer biomarker testing through project
TRANSCRIPT
Addressing Lung Cancer Biomarker Testing
Through Project ECHO: Session 16.28.2021
This project is generously supported by Amgen Oncology and Foundation
Medicine
Welcome to the First Combined Session of the Addressing Lung Cancer Biomarker
Testing Through Project ECHO Pilot
Addressing Lung Cancer Biomarker Testing Through Project ECHOEach ECHO session will be recorded and will be posted to echo.cancer.org
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Bruce Johnson, MD, FASCO
Chief Clinical Research Officer
Dana-Farber Cancer Institute
Professor of Medicine Harvard Medical School
Introductions & Agenda Preview
COMBINED SESSION 1
Today’s Agenda
01Housekeeping, Agenda Preview, & Introductions (15 minutes)
02Didactic Presentation: Understanding the Barriers to Biomarker Testing (15 minutes)
03 Didactic Q/A (5 minutes)
04 Case Presentation (5 minutes)
05Case Presentation Recommendations & Discussion (15 minutes)
06 Post-Session Poll & Wrap Up (5 minutes)
Faculty Introductions Meet Our
Faculty Members
17
Farhood Farjah, MD, MPH University of Washington
NLCRT Faculty Member
Bruce Johnson, MD Dana-Farber Cancer Institute
NLCRT Faculty Member
Patricia Rivera, MDUniversity of North Carolina
NLCRT Faculty Member
Ignacio Wistuba, MD MD Anderson Cancer Center
NLCRT Faculty Member
Gerard Silvestri, MD, MS Medical University of South Carolina
NLCRT Faculty Member
Eric Flenaugh, MD Grady Health System
GA Faculty Member
Adam Jones, MD Phoebe Putney Health System
GA Faculty Member
Suresh Ramalingam, MD Winship Cancer Institute
GA Faculty Member
Zhonglin Hao, MD, PHD UK Markey Cancer Center
KY Faculty Member
Jill Kolesar, PharmD, MSUK Markey Cancer Center
KY Faculty Member
Tim Mullett, MD, MBA UK Markey Cancer CenterKY/NLCRT Faculty Member
John Villano, MD, PHD UK Markey Cancer Center
KY Faculty Member
Ray Osarogiagbon, MBBS Baptist Cancer Center
MS/NLCRT Faculty Member
Pierre De Delva, MDUMMC Cancer Center & Research Institute
MS Faculty Member
Michal Senitko, MDUMMC Cancer Center & Research Institute
MS Faculty Member
Ralph Zinner, MD UK Markey Cancer Center
KY Faculty Member
Shadi Qasem, MD, MBA UK Markey Cancer Center
KY Faculty Member
Spoke (Chat) Introductions Meet Our
Spoke Sites
21
Georgia Spoke Sites Kentucky Spoke Sites Mississippi Spoke Sites
97
All spokes in Kentucky are part of the UK Markey Affiliate Network
5
Atrium Health Navicent Augusta University/Georgia
Cancer CenterNortheast Georgia Medical Center
Northside Hospital Cancer InstitutePhoebe Putney Health System
Piedmont Columbus Regional, JBACCSt. Joseph’s/Candler Health
System/Lewis Cancer & Research Pavilion
Highlands ARH Regional Medical CenterLake Cumberland Regional Hospital
St. Claire HealthcareLifePoint Central Kentucky: Clark
Regional Medical Center & Georgetown Community Hospital
Taylor Regional Hospital
Baptist Cancer CentersForrest General Hospital/
Hattiesburg Clinic Jackson Oncology Associates
North Mississippi Health Services St. Dominic’s Hospital
Singing River Health System Southwest Mississippi Regional
Medical CenterUMMC Cancer Center & Research
Institute G.V. (Sonny) Montgomery VA
Medical Center
Thank you for your participation!
Reminder: Please type your name and organization in the chat box
M. Patricia Rivera, MD, ATSF, FCCP
Professor of Medicine University of North Carolina at Chapel
Hill
Didactic Presentation: Understanding the Barriers to
Biomarker Testing
COMBINED SESSION 1
M. Patricia Rivera, MD, ATSF, FCCPProfessor of Medicine
University of North Carolina at Chapel Hill
UNDERSTANDING THE BARRIERS TO BIOMARKER TESTING
Understanding the Barriers to Biomarker Testing
• Overview:
• Personalized treatment of advanced non-small cell lung cancer (NSCLC) is
guided by molecular and diagnostic biomarker assessment
Genomic Profiling of Advanced NSCLC in Community Settings: Gaps and Opportunities. Clinical Lung Cancer 2017;18:651
Molecular Biomarkers in Practice
First Generation ALK Inhibitor vs. Alectinib for Previously Untreated ALK Rearranged Mutant NSCLC
Mok et al. Ann Oncol 2020 Aug;31(8):1056
• 101 treatment naïve and 449
previously treated patients
• Median follow up 60.6 months
Treatment
Naïve (N=101)
Previousl
y treated (N=449)
PD-L1
≥50%
PD-L1
≤50%
Median
OS
22
months10 months
Estimate
d 5-yr survival
23.5% 15.5% 29.6% 25%
J Clin Oncol 2019;37:2518-27
NEJM 2020; 383:640-649
Guideline-Recommendations
• Molecular Biomarkers:
• EGFR, ROS-1, ALK, MET, KRAS, RET, HER2, NTKR
• All patients with advanced stage adenocarcinoma, large cell carcinoma, and NSCLC
otherwise not specified (NOS)
• Select patients with squamous NSCLC (never smoking, < 50 y/o)
• Testing ideally done in labs that perform next-generation sequencing (NGS) panels.
• Diagnostic biomarker testing, (PD-L1 expression)
• In all patients with advanced stage NSCLC
1. CAP/AMP/IASLC Guidelines. Arch Pathol Lab Med. 2018;142(3):321-346.
2. NCCN Clinical Practice Guidelines. Non-Small Cell Lung Cancer. JNCCN 2021;19:254-266
Real World Data
-Most pts received at least
one biomarker test prior to
1st line therapy (1L)
- < 50% received all
5 tests.
-NGS testing occurred in
<50% of pts, increased
over time.
-Median time from dx to 1L
therapy was about 5 weeks
- Turn around time from
orders to results about 2
weeks.
Understanding the Barriers to Biomarker Testing
Knowledge gaps regarding need for testing
Lack of communication between stakeholders
Procuring adequate tissue for sampling
Choice of assay and design
Reimbursement, cost, and coverage
Turnaround time
Accurate interpretation of results
Biomarker Continuum:
Through Lens of Critical Stakeholders
• Proceduralists collect the tissue
• Pulmonologists, thoracic surgeons, interventional radiologists
• Cytologists and pathologists who analyze the tissue
• Confirm histologic diagnosis
• Perform in-house molecular testing
• Prepare slides to send out for molecular testing
• Medical oncologists interpret the results
• Nurse navigators
• Liaisons between patient and multiple clinicians
• Forms required for testing in-house and send outs
Process requires collaborative effort and frequent communication between the stakeholders
Understanding The Barriers to Biomarker Testing
Stakeholder Confessionals:
Primary Care:
• Lack of awareness of progress in treatments
• That lung cancer occurs in people who do not smoke
• Nihilism/hopelessness
• Lack of continued engagement in care following diagnosis
Proceduralists:
• Knowledge gaps about comprehensive biomarker testing
• Rapidly evolving treatment landscape is challenging
• Inadequate tissue sample collection• Insufficient passes
• Lack of core biopsies when feasible
Understanding The Barriers to Biomarker Testing
Stakeholder Confessionals:
Oncologists:
• Difficulty staying up to date, especially for general oncologists.
• Results inconsistently reported, difficult to interpret
• Delays in testing turnaround time
• Pressure to start treatment quickly
Pathologists:
• Knowledge gaps generalists of rapidly evolving treatment field.
• Diagnostic insecurities/fear of litigation results in exhaustion of available tissue
• Limited communication/isolation from colleagues
Understanding The Barriers to Biomarker Testing
Stakeholder Confessionals:
Payers:
• Prior authorization to review evidence of benefit of the test and/or the targeted agent
• Evolving field requires evaluation of the evidence to maintain contemporary
coverage policies
• Payers selective regarding which labs are in network• To provide high quality and affordable care
• Different payers have different coverage policies and different in-network labs
• Creates administrative burden on the ordering providers.
• Coding variances require administrative resources • Review medical documents and reconcile with submitted claims.
Understanding the Barriers to Biomarker Testing
• Summary:
• Biomarker assessment is critical to guide therapy in advanced NSCLC
• Treatment with targeted therapies directed at specific molecular target result in improved outcomes
• Decisions regarding immunotherapy alone or combined with chemo best made with knowledge of PD-L1 expression
• Suboptimal testing rates with variability across health care systems
• Multiple barriers result in low testing rates
National Lung Cancer Roundtable SummitOptimizing Lung Cancer Biomarkers in Practice
• Objectives:• Bring organizations together to bridge gaps in biomarker testing.
• Share clinical experiences related to biomarker testing.
• Review best practices regarding tissue acquisition, choice of assay, reimbursement, and turn around time.
• Align on strategies to optimize patients’ and physicians’ awareness of biomarker testing to increase uptake.
• Develop strategies that NLCRT and member organizations can embrace to optimize use of lung cancer biomarkers in practice.
Didactic Q & A
Philip Lammers, MD
Medical Director of Clinical Oncology
Research
Baptist Cancer Center
Case Presentation:Baptist Cancer Center
COMBINED SESSION 1
Specific Question(s) to the Faculty
Q1
Have others implemented a large scale NGS testing process and what feedback can you give for the implementation process?
Case Presentation Discussion
Post-Session Poll Questions
Wrap-Up
A Few Reminders
Next Kentucky ECHO Session: 7/12/2021 @ 5:00 PM ETNext Georgia ECHO Session: 7/21/2021 @ 12:00 PM ET Next Mississippi ECHO Session: 7/27/2021 @ 7:00 AM CT
Topic for all sessions: Pathways to Biomarker Testing
Materials and resources will be made available within one week.
All resources will be available at echo.cancer.org
Case Presentations
Spokes: Interested in scheduling your Case Presentation? Let us know.
Faculty: All future case presentations will be shared with you at 24-hours in advance.
Additional Feedback on Today’s Session? Tell us in the Post Session Feedback Forum
(URL in chat box)
Questions: Contact your regional leads, Jessica Davis, Beth Dickson-Gavney, Julie
Waters or Kelly Durden
Thank you to Amgen for their generoussupport!
SEE YOU IN JULY!