BRIEF REPORT: Real-world efficacy and safety of amivantamab for EGFR-mutant non-small cell lung cancer (NSCLC).

BACKGROUND: Amivantamab-vmjw (amivantamab) is a bispecific EGFR/MET antibody approved for patients with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 20 insertion mutations, after prior therapy. However, the benefits and safety of amivantamab in other EGFR-mutation lung cancer, with or without osimertinib, and with concurrent radiation therapy, are less known.

METHODS: We queried the MD Anderson Lung Cancer GEMINI, Fred Hutchinson Cancer Research Center, University of California Davis Comprehensive Cancer Center and Stanford Cancer Center's database for patients with EGFR-mutant NSCLC treated with amivantamab, not on a clinical trial. The data analyzed included initial response, duration of treatment, and concomitant radiation safety in overall population and prespecified subgroups.

RESULTS: Sixty-one patients received amivantamab. Median age was 65 (31 - 81); 72.1% were female and 77% were patients with never smoking history. Median number of prior lines of therapies were four. Based on tumor's EGFR mutation, 39 patients were in the classical mutation cohort; 15 patients in the Exon20 cohort; and 7 patients in the atypical cohort. Thirty-seven patients (58.7%) received amivantamab concomitantly with osimertinib and 25 patients (39.1%) received concomitant radiation. Fifty-four patients were evaluable for response in the overall population; 19 patients (45.2%) had clinical response and disease control rate (DCR) was 64.3%. In the classical mutation cohort of the 33 evaluable patients, twelve (36.4%) had clinical response and DCR was 48.5%. In the atypical mutation cohort, six of the seven patients (85.7%) had clinical response and DCR was 100%. Of the 13 patient evaluable patients in the Exon 20 cohort, five patients (35.7%) had clinical response and DCR was 64.3%. Adverse events reported with amivantamab use were similar as previously described in product labeling. No additional toxicities were noted when amivantamab was given with radiation and/or osimertinib.

CONCLUSION: Our real-world multi-center analysis demonstrated that amivantamab is a potentially effective treatment option for patients with EGFR mutations outside of Exon 20 insertion mutations. The combination of osimertinib with amivantamab is safe and feasible. Radiation therapy also appears safe when administered sequentially or concurrently with amivantamab.