FDA Approves Rybrevant-Chemo Combination for EGFR-Positive Lung Cancer

The Food and Drug Administration approved Rybrevant plus carboplatin and pemetrexed for locally advanced or metastatic non-small cell lung cancer (NSCLC) that has EGFR exon 20 insertion mutations.

The Food and Drug Administration (FDA) approved Rybrevant (amivantamab-vmjw) plus carboplatin and pemetrexed for the frontline treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has EGFR exon 20 insertion mutations that are detected by an FDA-approved test, according to the agency.

The FDA also approved Rybrevant for adults with the disease who experienced disease progression on or after a platinum-based chemotherapy.

The approvals were based on findings from the PAPILLION clinical trial, which included 308 patients with EGFR exon 20 insertion mutations. Patients were randomly assigned to one of two treatment groups: half received Rybrevant with carboplatin and pemetrexed, while the other half received only carboplatin and pemetrexed.

Findings showed that the Rybrevant-containing regimen outperformed carboplatin/pemetrexed when it came to progression-free survival (PFS; time patients live after treatment before their disease worsened. The median PFS was 11.4 months for patients who had Rybrevant, compared with 6.7 months for patients who received carboplatin/pemetrexed.

Overall survival data — which measures the length of time patients live before death of any cause — were immature at the time of the approval, meaning that researchers did not have enough data to calculate an average. However, according to the FDA, no trend toward a detriment was observed.

The most common side effects observed with Rybrevant that occurred in 20% or more of patients included rash, nail issues, stomatitis, infusion-related reaction, fatigue, edema, constipation, decreased apetite, nausea, COVID-19, diarrhea and vomiting.

March 4, 2024