FDA Approves Amivantamab for Patients With EGFR Exon 20 Insertion-Mutated Non-Small Cell Lung Cancer

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.

The most common adverse reactions occurring in ≥20% of patients included rash, nail toxicity, stomatitis, infusion-related reaction, fatigue, edema, constipation, decreased appetite, nausea, COVID-19, diarrhea, and vomiting. 

Source:

FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications. Published online: March 1, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-egfr-exon-20-insertion-mutated-non-small-cell-lung-cancer-indications