On March 1, the US Food and Drug Administration approved amivantamab-vmjw with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. The FDA also granted traditional approval to amivantamab-vmjw for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. The agency previously granted accelerated approval for this indication in May 2021.
The approvals were based on data from PAPILLON, a randomized, open-label multicenter trial of 308 patients with EGFR exon 20 insertion mutations. Patients were randomized 1:1 to receive amivantamab-vmjw with carboplatin and pemetrexed or carboplatin and pemetrexed.
The primary efficacy outcome was progression-free survival (PFS) with overall survival (OS) as a key secondary outcome measure. Amivantamab-vmjw plus carboplatin and pemetrexed demonstrated a statistically significant improvement in PFS compared with carboplatin and pemetrexed with a hazard ratio of 0.40 (95% CI: 0.30, 0.53; p-value<0.0001). The median PFS was 11.4 months (95% CI: 9.8, 13.7) and 6.7 months (95% CI: 5.6, 7.3) in the respective arms. Overall survival results were immature at the time of analysis.
