Amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed has been green-lighted by the FDA for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.1
Researchers evaluated the treatment’s efficacy in MARIPOSA-2 (NCT04988295), a randomized, open-label, multicenter trial in patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations and disease progression on or after receiving osimertinib. Six hundred and fifty-seven patients were randomly assigned to receive either amivantamab-vmjw with carboplatin and pemetrexed (amivantamab + CP), carboplatin and pemetrexed (CP), or amivantamab-vmjw as part of another combination regimen.
Median progression-free survival (PFS) was 6.3 months (95% CI, 5.6-8.4) in the amivantamab + CP arm and 4.2 months (95% CI, 4.0-4.4) in the CP arm (HR, 0.48; 95% CI, 0.36-0.64; P<.0001). The confirmed overall response rate was 53% (95% CI, 44-62) in the amivantamab + CP arm and 29% (95% CI, 23-35) in the CP arm (P<.0001). At the prespecified second interim analysis of overall survival (OS), with 85% of the deaths needed for the final analysis, there was no statistically significant difference in OS. The stratified OS hazard ratio was 0.73 (95% CI, .54-.99).
The most commonly reported adverse reactions were rash, infusion-related reactions, fatigue, nail toxicity, nausea, constipation, edema, stomatitis, decreased appetite, musculoskeletal pain, vomiting, and COVID-19 infection.
References
- FDA approves amivantamab-vmjw with carboplatin and pemetrexed for non–small cell lung cancer with EGFR exon 19 deletions or L858R mutations. FDA. September 19, 2024. Accessed October 10, 2024. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-carboplatin-and-pemetrexed-non-small-cell-lung-cancer-egfr-exon-19