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Spotlight on Amivantamab (JNJ-61186372) for EGFR Exon 20 Insertions Positive Non-Small Cell Lung Cancer.

ABSTRACT: Non-small cell lung cancer (NSCLC) patients demonstrating sensitizing oncogenic driver mutations have derived clinical benefit from targeted therapy. EGFR mutations constitutively activate the signaling pathway, leading to prosurvival and antiapoptotic signals. Classic sensitizing EGFR mutations, such as exon 19 deletions and exon 21 L858R point mutations, respond well to tyrosine kinase inhibitors (TKIs). On the other hand, EGFR exon 20 in-frame insertions are observed in 4-12% of EGFR-mutated NSCLC and are resistant to targeted therapy with TKIs. In May 2021, the Federal Drug Administration (FDA) provided accelerated approval to amivantamab (Rybrevant) in adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations after treatment with platinum-based chemotherapy. Here, we discuss properties of amivantamab, clinical trial results, and management of patients with EGFR exon 20 insertion mutated NSCLC.

SUBMITTER: Brazel D

PROVIDER: S-EPMC8648093 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Spotlight on Amivantamab (JNJ-61186372) for EGFR Exon 20 Insertions Positive Non-Small Cell Lung Cancer.

Brazel Danielle D Nagasaka Misako M

Lung Cancer (Auckland, N.Z.) 20211202

Non-small cell lung cancer (NSCLC) patients demonstrating sensitizing oncogenic driver mutations have derived clinical benefit from targeted therapy. EGFR mutations constitutively activate the signaling pathway, leading to prosurvival and antiapoptotic signals. Classic sensitizing EGFR mutations, such as exon 19 deletions and exon 21 L858R point mutations, respond well to tyrosine kinase inhibitors (TKIs). On the other hand, EGFR exon 20 in-frame insertions are observed in 4-12% of EGFR-mutated ...[more]

PMID: 34880698

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Project description:BackgroundIn non-small cell lung cancer (NSCLC), the epidermal growth factor receptor (EGFR) mutation is a representative oncogenic driver mutation. Only about 12% of EGFR mutation patients have the exon 20 insertion mutation, which is the third most frequent mutation among EGFR mutation NSCLC. Amivantamab, an EGFR and MET proto-oncogene, receptor tyrosine kinase (MET) bispecific antibody, was approved for NSCLC patients with the EGFR exon 20 insertion (E20I) mutation. In this study, we described the real-world, single-center efficacy and safety data of amivantamab in E20I mutation patients.MethodsThis study included metastatic NSCLC patients with EGFR E20I mutations. From January 2018 to June 2022, patients with EGFR E20I mutations who were treated with amivantamab were analyzed at Samsung Medical Center as part of the clinical trial or the early access program (EAP). We collected the patients' characteristics [age, sex, smoking history, location of mutation, sites of metastasis, programmed death-ligand 1 (PD-L1) expression status, etc.] and analyzed progression-free survival (PFS) and overall survival (OS) stratified by PD-L1 expression status, co-mutation such as tumor protein p53 (TP53), and metastasis sites.ResultsA total of 42 patients were analyzed, of which 16 patients were enrolled in the phase 1 study, and 26 patients received amivantamab through EAP. There were 14 (33%) patients with partial remission, 18 (43%) patients with stable disease, and 10 (24%) patients with disease progression. The objective response rate (ORR) was 33%, and the disease control rate (DCR) was 76%. PFS was analyzed by dividing the near and far loop for 31 patients whose mutation location was known. The two groups had no statistically significant difference in PFS [median (range): 11.8 (2.3-21.3) vs. 11.3 (3.4-19.2) months, P=0.69]. For 29 patients with TP53 mutation data, there was no significant difference in PFS between the two groups [median (range): 5.9 (0-18.0) vs. 12.6 (6.9-18.3) months, P=0.11]. When analyzing PFS in 37 patients with PD-L1 expression data, PD-L1 (+) patients showed a poor prognosis [median (range): 11.3 (5.0-17.6) vs. 19.5 (5.3-33.7) months, P=0.04; hazard ratio (HR), 0.44; 95% confidence interval (CI): 0.20-0.98].ConclusionsThe efficacy of amivantamab was confirmed for the real-world population for EGFR E20I-mutated NSCLC. PD-L1 status could be a poor predictive factor, which should be further validated.

Dataset Information

Spotlight on Amivantamab (JNJ-61186372) for EGFR Exon 20 Insertions Positive Non-Small Cell Lung Cancer.

Publications

Spotlight on Amivantamab (JNJ-61186372) for EGFR Exon 20 Insertions Positive Non-Small Cell Lung Cancer.

Similar Datasets

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