Summary
The FDA has approved amivantamab for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.
Article
On March 1, 2024, the US Food and Drug Administration (FDA) approved amivantamab plus carboplatin and pemetrexed in the first-line setting for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 mutations, as detected by an FDA-approved test.
Additionally, amivantamab as a monotherapy was approved for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutation after progression on or after platinum-based chemotherapy; the FDA had previously granted this indication an accelerated approval.
This regulatory decision was based on updated results from the phase 3 PAPILLON trial.
In this multicenter, open-label trial, 308 patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 mutations were randomized on a 1-to-1 basis to receive either amivantamab with carboplatin and pemetrexed or carboplatin and pemetrexed. The major efficacy outcome measure was progression-free survival (PFS), as assessed by blinded independent central review. A key secondary outcome measure was overall survival (OS).
At analysis, the median PFS was 11.4 months in the amivantamab arm and 6.7 months in the carboplatin arm (hazard ratio [HR], 0.40; 95% confidence interval [CI]; 0.30 to 0.53; P < 0.0001). OS results were immature, however 44% of pre-specified deaths for the final analysis were reported, indicating no trend towards a detriment.
