EGFR EXON 20 INSERTION MUTATIONS ARE THE 3RD MOST PREVALENT PRIMARY EGFR MUTATION, YET THEY ARE OFTEN UNDETECTED4

CURRENT TKI THERAPIES ARE NOT EFFECTIVE AT TREATING PATIENTS WITH EXON 20 INSERTION MUTATIONS, MAKING THEM MORE DIFFICULT TO TREAT THAN CLASSICAL EGFR MUTATIONS3,6-9

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THE MOST THREATENING EGFR MUTATION
MAY BE THE ONE YOU DON’T SEE

Exon 20 insertion mutations in EGFR+ mNSCLC are more elusive and life-threatening than common EGFR mutations.1-10
These mutations differ from classical mutations, such as L858R and exon 19 deletions, in how they are detected and treated...
...leaving patients at risk of rapid disease progression on current targeted therapies.1-10

EGFR EXON 20 INSERTION MUTATIONS ARE THE 3RD MOST PREVALENT PRIMARY EGFR MUTATION, YET THEY ARE OFTEN UNDETECTED4

Current biomarker testing practices can make it difficult to identify these patients4,5,7,11

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PCR-based tests, which are mutation-specific, have technical limitations and can only detect a limited number of exon 20 insertion mutations4,7,11

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Exon 20 insertion mutations cannot be treated effectively with current targeted therapies. Therefore, they are not given prominence on the NGS report1,3,5-9

Through the use of testing techniques that detect a broader range of mutations—either liquid or tissue NGS—and careful examination of biomarker test results, you can better understand the full picture of treatment options for your patients with EGFR-positive mNSCLC.4,11,12

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) strongly advise broader molecular profiling in eligible patients with mNSCLC, with the goal of identifying rare driver mutations.13*†

BUT ACCURATE DETECTION IS ONLY THE FIRST STEP IN FIGHTING THIS MUTATION

CURRENT TKI THERAPIES ARE NOT EFFECTIVE AT TREATING PATIENTS WITH EXON 20 INSERTION MUTATIONS, MAKING THEM MORE DIFFICULT TO TREAT THAN CLASSICAL EGFR MUTATIONS3,6-9

Exon 20 insertion mutations are intrinsically resistant to EGFR TKIs, unlike common sensitizing mutations (eg, L858R and exon 19 deletions) or EGFR exon 20 T790M mutations.3,6-9

Response to TKIs in treatment-naive patients:

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EGFR exon 20 insertion mutations14,15

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EGFR exon 20 insertion mutations10

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Classical EGFR exon 19 deletion or L858R mutation16

‡Results from a real-world analysis of treatment patterns (95% confidence interval [CI], 2.8-19.4).10

§The median overall survival was 38.6 months (95% CI, 34.5 to 41.8) in the osimertinib group and 31.8 months (95% CI, 26.6 to 36.0) in the comparator group (hazard ratio for death, 0.80; 95.05% CI, 0.64 to 1.00; P=0.046).16

The NCCN Guidelines® recommend treating patients without a sensitizing EGFR mutation, like patients with most exon 20 insertion mutations, with a systemic therapy, like platinum-based chemotherapy.13¶

Progression-free survival in treatment-naive patients with exon 20 insertion mutations:

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Platinum-based chemotherapy17-19

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TKIs3||

||TKIs included in this analysis were erlotinib, gefitinib, and afatinib.3

DON’T LET THIS MUTATION GET BY YOU. TEST FOR, FIND, AND APPROPRIATELY MANAGE EXON 20 INSERTION MUTATIONS.

YOUR PATIENTS’ LIVES DEPEND ON IT

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EGFR, epidermal growth factor receptor; mNSCLC, metastatic non–small cell lung cancer; NCCN, National Comprehensive Cancer Network; NGS, next-generation sequencing; ORR, overall response rate; PCR, polymerase chain reaction; TKI, tyrosine kinase inhibitor.

*It is recommended at this time that, when feasible, molecular testing be performed via a broad, panel-based approach, most typically performed by NGS.13

†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.

See the NCCN Guidelines for detailed recommendations for platinum-based chemotherapy regimens.13

References: 1. Physician Insert: Oncomine™ Dx Target Test. Thermo Fisher Scientific Inc. https://www.accessdata.fda.gov/cdrh_docs/pdf16/p160045d.pdf. 2. Chiang AC, Fernandes AW, Pavilack M, et al. EGFR mutation testing and treatment decisions in patients progressing on first- or second-generation epidermal growth factor receptor tyrosine kinase inhibitors. BMC Cancer. 2020;20(1):356. doi:10.1186/s12885-020-06826-0 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. 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 5. FoundationOne®CDx. Technical specifications. Foundation Medicine. Accessed September 25, 2020. https://assets.ctfassets.net/w98cd481qyp0/YqqKHaqQmFeqc5ueQk48w/0a34fcdaa3a71dbe460cdcb01cebe8ad/F1CDx_Technical_Specifications_072020.pdf. 6. 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 7. Oxnard GR, Lo PC, Nishino M, et al. Natural history and molecular characteristics of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol. 2013;8(2):179-184. doi:10.1097/JTO.0b013e3182779d18 8. Naidoo J, Sima C, Rodriguez K, et al. Epidermal growth factor receptor exon 20 insertions in advanced lung adenocarcinomas: clinical outcomes and response to erlotinib. Cancer. 2015;121(18):3212–3220. doi:10.1002/cncr.29493 9. Chen D, Song Z, Cheng G. Clinical efficacy of first-generation EGFR-TKIs in patients with advanced non-small-cell lung cancer harboring EGFR exon 20 mutations. Onco Targets Ther. 2016;9:4181-4186 10. Dersarkissian M, Bhak R, Lin H, et al. P2.01-103 Real-world treatment patterns and survival in non-small cell lung cancer patients with EGFR Exon 20 insertion mutations. J Thorac Oncol. 2019;14(10)(suppl S681). doi:10.1016/j.jtho.2019.08.1446 11. Pennell NA, Arcila ME, Gandara DR, West H. Biomarker testing for patients with advanced non-small cell lung cancer: Real-world issues and tough choices. Am Soc Clin Oncol Educ Book. 2019;39(39):531-542. 12. Del Re M, Crucitta S, Gianfilippo G, et al. Understanding the mechanisms of resistance in EGFR-positive NSCLC: from tissue to liquid biopsy to guide treatment strategy. Int J Mol Sci. 2019;20(16):3951. doi:10.3390/ijms20163951 13. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.8.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed November 17, 2020. 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. 14. Kate S, Chougule A, Joshi A, et al. Outcome of uncommon EGFR mutation positive newly diagnosed advanced non-small cell lung cancer patients: a single center retrospective analysis. Lung Cancer (Auckl). 2019;10:1-10. doi:10.2147/LCTT.S181406 15. Yang JC, Sequist LV, Geater SL, et al. Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6. Lancet Oncol. 2015;16(7):830-838. doi:10.1016/S1470-2045(15)00026-1 16. Ramalingam SS, Vansteenkiste J, Planchard D, et al. Overall survival with osimertinib in untreated, EGFR-mutated advanced NSCLC. N Engl J Med. 2020;382(1):41-50. doi:10.1056/NEJMoa1913662 17. Wang Y, Yang G, Li J, et al. Real-world treatment outcome of advanced Chinese NSCLC EGFR exon 20 insertion patients. J Clin Oncol. 2019;37(15)(suppl 9043). doi:10.1200/JCO.2019.37.15_suppl.9043 18. Zhao C, Li X, Su C, et al. P1.01-111 EGFR exon20 insertion patients treated with first-line chemotherapy in non-small cell lung cancer. J Thorac Oncol. 2018;13(10)(suppl S507). doi:10.1016/j.jtho.2018.08.668 19. Cardona AF, Rojas L, Zatarain-Barrón ZL, et al. EGFR exon 20 insertion in lung adenocarcinomas among Hispanics (geno1.2-CLICaP). Lung Cancer. 2018;125:265-272. doi:10.1016/j.lungcan.2018.10.007



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Last Updated December 2020 cp-181863v1