FDA Approves Amivantamab-Chemo Combo for Advanced NSCLC

The FDA approved amivantamab-vmjw (Rybrevant) plus carboplatin and pemetrexed for adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) that harbors EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR TKI.

The regulatory decision was supported by data from the phase 3 MARIPOSA-2 trial (NCT04988295), which showed that the median progression-free survival (PFS) was 6.3 months (95% CI, 5.6-8.4) in the amivantamab arm compared with 4.2 months (95% CI, 4.0-4.4) in the chemotherapy arm (HR, 0.48; 95% CI, 0.36-0.64; P < .0001). Amivantamab plus chemotherapy elicited a confirmed overall response rate of 53% (95% CI, 44%-62%) vs 29% (95% CI, 23%-35%) for chemotherapy alone (P < .0001).

Data from a prespecified second interim analysis showed there was no statistically significant difference in overall survival (stratified HR, 0.73; 95% CI, 0.54-0.99).

The most common adverse effects reported in at least 20% of patients with the amivantamab regimen were rash, infusion-related reactions, fatigue, nail toxicity, nausea, constipation, edema, stomatitis, decreased appetite, musculoskeletal pain, vomiting, and COVID-19 infection.

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 September 19, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-carboplatin-and-pemetrexed-non-small-cell-lung-cancer-egfr-exon-19