Tumor Analyses Reveal Squamous Transformation and Off-Target Alterations As Early Resistance Mechanisms to First-line Osimertinib in EGFR -Mutant Lung Cancer
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Abstract
Purpose: Patterns of resistance to first-line osimertinib are not well-established and have primarily been evaluated using plasma assays, which cannot detect histologic transformation and have differential sensitivity for copy number changes and chromosomal rearrangements. Experimental Design: To characterize mechanisms of resistance to osimertinib, patients with metastatic EGFR-mutant lung cancers who received osimertinib at Memorial Sloan Kettering Cancer Center and had next-generation sequencing performed on tumor tissue before osimertinib initiation and after progression were identified. Results: Among 62 patients who met eligibility criteria, histologic transformation, primarily squamous transformation, was identified in 15% of first-line osimertinib cases and 14% of later-line cases. Nineteen percent (5/27) of patients treated with first-line osimertinib had off-target genetic resistance (2 MET amplification, 1 KRAS mutation, 1 RET fusion, and 1 BRAF fusion) whereas 4% (1/27) had an acquired EGFR mutation (EGFR G724S). Patients with squamous transformation exhibited considerable genomic complexity; acquired PIK3CA mutation, chromosome 3q amplification, and FGF amplification were all seen. Patients with transformation had shorter time on osimertinib and shorter survival compared with patients with on-target resistance. Initial EGFR sensitizing mutation, time on osimertinib treatment, and line of therapy also influenced resistance mechanism that emerged. The compound mutation EGFR S768 + V769L and the mutation MET H1094Y were identified and validated as resistance mechanisms with potential treatment options. Conclusions: Histologic transformation and other off-target molecular alterations are frequent early emerging resistance mechanisms to osimertinib and are associated with poor clinical outcomes. See related commentary by Piotrowska and Hata, p. 2441
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In two NSCLC patients without an identified genomic resistance mechanism, histologic transformation from adenocarcinoma to squamous-cell carcinoma was observed, suggesting nongenetic mechanisms of resistance to KRASG12C inhibition may occur.
“In two patients with NSCLC for whom we were not able to identify a genomic resistance mechanism, we observed histologic transformation from adenocarcinoma to squamous-cell carcinoma, which suggests that nongenetic mechanisms of resistance to KRASG12C inhibition may occur, similar to those observed with other targeted therapies in lung cancer.24-26”
From Acquired Resistance to KRAS <sup>G12C</sup> Inhibition in Cancer (2021) · cites this paper as [26]
Histologic transformation of lung adenocarcinoma to small cell carcinoma accounts for 5-15% of EGFR-mutant lung cancer patients with acquired resistance to EGFR TKIs.
“the histologic transformation of lung adenocarcinoma subtype to small cell carcinoma subtype, which accounts for 5–15% of EGFR-mutant lung cancer patients with acquired resistance to EGFR TKIs [12,17].”
From Emerging Insights into Targeted Therapy-Tolerant Persister Cells in Cancer (2021) · cites this paper as [17]
Dual MET/KRAS (G12C) inhibition resulted in tumor shrinkage in AMG510-resistant xenograft mice.
“Dual MET/KRAS (G12C) inhibition resulted in tumor shrinkage in AMG510-resistant xenograft mice [94, 113].”
From Targeting KRAS mutant cancers: from druggable therapy to drug resistance (2022) · cites this paper as [113]
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- Authors
- Schoenfeld, A. J., Chan, J. M., Kubota, D., Sato, H., Rizvi, H., Daneshbod, Y., Chang, J. C., Paik, P. K., Offin, M., Arcila, M. E., Davare, M. A., Shinde, U., Pe'er, D., Rekhtman, N., Kris, M. G., Somwar, R., Riely, G. J., Ladanyi, M., & Yu, H. A.
- Affiliations
- Memorial Sloan Kettering Cancer Center (US)
- Oregon Health & Science University (US)
- 7Program for Computational and System Biology, Sloan Kettering Institute, Memorial Sloan Kettering, New York, New York.
- ORCID
- Venue
- Clinical Cancer Research
- Published
- 2020-06-01
- Volume
- 26
- Issue
- 11
- Pages
- 2654-2663
- ISSN
- 1078-0432 (ISSN-L)
- 1557-3265
- PMC
- PMC7448565
- OpenAlex
- W2999801017
- Cited by
- 411
- References
- 49
- Citations by year
- 2026: 55 · 2025: 59 · 2024: 69 · 2023: 73 · 2022: 57 · 2021: 70 · 2020: 28
- FWCI
- 32.13
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by
- Locations
- Clinical Cancer Research (publishedVersion, cc-by)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- HHS | NIH | National Cancer Institute (T32 CA009207, P30 CA008748)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
- Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
- Keywords
- osimertinib, EGFR-mutant lung cancer, acquired drug resistance, squamous cell carcinoma transformation, histologic transformation, MET amplification, KRAS mutation, RET fusion, BRAF fusion, PIK3CA mutation, metastatic lung cancer, first-line targeted therapy
- MeSH terms
- Acrylamides, Aniline Compounds, Carcinoma, Squamous Cell, Humans, Indoles, Lung Neoplasms, Mutation, Pyrimidines, Drug Resistance, Neoplasm, Protein Kinase Inhibitors, ErbB Receptors
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