Addressing Lung Cancer Biomarker Testing Through Project ...

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!