Comprehensive biomarker testing is essential for identifying patients with EGFR exon 20 insertion mutation+ mNSCLC

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EGFR exon 20 insertion mutations are the third most prevalent primary EGFR mutation in mNSCLC, accounting for up to 9% of all EGFR mutations1,2

Compared with classical mutations, EGFR exon 20 insertion mutations reduce the size of the drug-binding pocket and affinity for most TKIs indicated for classical EGFR mutations.3*

*A763_Y764FQEA does not cause steric hindrance in the drug-binding pocket and has been shown to be sensitive to currently approved TKIs.4

Expert guidelines recommend broad, panel-based molecular testing5

  • The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC strongly advise broader molecular profiling for eligible patients with advanced or metastatic NSCLC, with the goal of identifying rare driver mutations5†‡
  • Broad molecular profiling is a key component for the improvement of care for patients with NSCLC5

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.5

It is recommended at this time that, when feasible, molecular testing be performed via a broad, panel-based approach, most typically performed by next-generation sequencing (NGS).5

Use an FDA-approved NGS test to accurately identify patients with EGFR exon 20 insertion mutations who may benefit from treatment with RYBREVANT®.6

Mechanism of Disease

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Learn what makes EGFR exon 20 insertion mutations different.1-3*

*A763_Y764FQEA does not cause steric hindrance in the drug-binding pocket and has been shown to be sensitive to currently approved TKIs.4

EGFR, epidermal growth factor receptor; FDA, Food and Drug Administration; mNSCLC, metastatic non-small cell lung cancer; NCCN, National Comprehensive Cancer Network®; NGS, next-generation sequencing; TKI, tyrosine kinase inhibitor.

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References

1. Riess JW, Gandara DR, Frampton GM, et al. Diverse EGFR exon 20 insertions and co-occurring molecular alterations identified by comprehensive genomic profiling of NSCLC. J Thorac Oncol. 2018;13(10):1560-1568. doi:10.1016/j.jtho.2018.06.019

2. Arcila ME, Nafa K, Chaft JE, et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics. Mol Cancer Ther. 2013;12(2):220-229. doi:10.1158/1535-7163.MCT-12.0620

3. Robichaux JP, Elamin YY, Tan Z, et al. Mechanisms and clinical activity of an EGFR and HER2 exon 20-selective kinase inhibitor in non-small cell lung cancer. Nat Med. 2018;24(5):638-646. doi:10.1038/s41591-018-0007-9

4. Yasuda H, Park E, Yun CH, et al. Structural, biochemical, and clinical characterization of epidermal growth factor receptor (EGFR) exon 20 insertion mutations in lung cancer [published correction appears in Sci Transl Med. 2014 Feb 26;6(225):225er1]. Sci Transl Med. 2013;5(216):216ra177. doi:10.1126/scitranslmed.3007205

5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed March 16, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. 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.

6. RYBREVANT® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.