The importance of obtaining complete biomarker test results prior to initiating first-line therapy in mNSCLC

About 1 in 2

About 1 in 2 patients with mNSCLC have biomarkers with approved, emerging, or evolving therapeutics.2,4

RET fusions are 1 of 8 driver alterations with FDA-approved therapies2,4*

1 of 8 alterations

*Current as of May 2022.
Emerging Therapeutics=currently being studied in clinical trials; Evolving Therapeutics=either proof-of-concept studies or in a very early clinical stage.
ALK=anaplastic lymphoma kinase; BRAF=B-Raf proto-oncogene; EGFR=endothelial growth factor receptor; ERBB2=receptor tyrosine kinase ErbB2 (human EGF receptor 2 or HER2); KRAS=Kirsten rat sarcoma; MET=MET proto-oncogene; mNSCLC=metastatic non–small cell lung cancer; NTRK=neurotrophic tyrosine receptor kinase; RET+=rearranged during transfection positive; ROS1=ROS proto-oncogene 1.

Talk to your pathologist or lab partners to determine how to best test comprehensively for all biomarkers in mNSCLC, including RET

Comprehensive biomarker testing can assess most actionable biomarkers with one test—so you can identify which biomarker may be responsible for driving disease5

The National Comprehensive Cancer Network® (NCCN®) NSCLC Panel recommends that eligible patients with metastatic NSCLC receive routine biomarker testing for2:

  • EGFR mutations
  • ALK fusions
  • ROS1 fusions
  • BRAF mutations
  • KRAS G12C mutations
  • METex14 skipping mutations
  • RET rearrangements
  • NTRK1/2/3 gene fusions
  • PD-L1 expression levels

Insufficient tissue (or QNS) is not a conclusive result and may lead to an uninformed treatment decision2

NGS-based tissue genotyping and plasma ctDNA testing are considered accurate, reliable, and complementary approaches to test for actionable biomarkers, including RET alterations.6

  • Testing of plasma ctDNA may overcome some of the limitations of tumor tissue genotyping due to faster turnaround time and a less invasive procedure6
  • Plasma ctDNA testing is recommended by both IASLC and NCCN under certain circumstances2,6

IASLC Guidelines6

Plasma ctDNA can now be considered a valid tool for genotyping of newly diagnosed patients with advanced NSCLC and should be performed using a clinically validated NGS platform

NCCN Clinical Practice Guidelines in Oncology

NCCN Guidelines® recommend plasma ctDNA testing as an option when there is limited tissue availability or the patient is unfit for invasive tissue sampling

Checkmark shield

The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories.
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
ctDNA=circulating tumor DNA; IASLC=International Association for the Study of Lung Cancer; NCCN=National Comprehensive Cancer Network® (NCCN®); NGS=next generation sequencing; PD-L1=programmed death-ligand 1; QNS=quality not sufficient.

Use biomarker test results to help guide treatment decisions in mNSCLC4,7,8

Reviewing biomarker test results before initiating treatment could help determine an appropriate treatment plan8

targeted therapy

Targeted therapies may lead to better outcomes in patients with actionable biomarkers8-11

  • Although many mNSCLC patients have derived benefit from immunotherapy (IO), some biomarker-driven cancers may respond poorly to IO treatment12-15
    • mNSCLC patients with biomarkers are often excluded from IO clinical trials13,16
    • In a retrospective study of 551 advanced NSCLC patients, IO response rates in select biomarker-driven NSCLC were12:
      • ALK (n=23): 0%
      • RET (n=16): 6%
      • EGFR (n=125): 12%
      • KRAS (n=271): 26%
      • BRAF (n=43): 24%
      • ROS1 (n=7): 17%
      • MET (n=36): 16%
NCCN Guidelines

Guidelines state that, for eligible patients with metastatic NSCLC who have actionable genetic variants, targeted therapy2:

  • is recommended as a first-line treatment option
  • has been shown to decrease tumor burden, decrease symptoms, and dramatically improve quality of life
  • for the oncogenic driver should take precedence over treatment with an immune checkpoint inhibitor, even when PD-L1 expression is elevated in patients with an oncogenic driver
RET fusion DNA

Select patients for treatment based on the presence of a RET gene fusion. Consider a selectively designed RET inhibitor1

Information on FDA-approved tests for RET gene fusions is available at http://www.fda.gov/CompanionDiagnostics