Rybrevant Plus Chemo Approved by FDA in Lung Cancer Subset

The Food and Drug Administration (FDA) has approved Rybrevant (amivantamab-vmjw) plus chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or L858R mutations.

Specifically, the approved treatment combination included Rybrevant plus carboplatin and pemetrexed chemotherapy. Eligible patients include those with locally advanced or metastatic NSCLC and EGFR exon 19 deletions or L858R mutations who have experienced disease progression (worsening or spreading) on or after receiving an EGFR tyrosine kinase inhibitor (TKI), according to the FDA’s alert.

The approval was based on the phase 3 MARIPOSA-2 trial, which evaluated the effectiveness of the Rybrevant-chemotherapy combination, in which researchers randomly assigned patients to three treatment groups. According to the alert, treatment groups included Rybrevant plus carboplatin and pemetrexed; carboplatin plus pemetrexed; or Rybrevant added to another combination regimen.

Findings from the MARIPOSA-2 trial were recently presented at the 2024 ESMO Congress.

Of note, the major outcomes measured in the trial included progression-free survival (PFS; time patients live without experiencing disease worsening or spreading) after the treatment with Rybrevant plus carboplatin and pemetrexed.

The secondary goals of the study were to determine the overall response rate (ORR; percentage of patients whose tumors shrunk or disappeared after treatment) and overall survival (OS; time patients live, regardless of their disease status).

Based on the results of the trial, the median PFS was 6.3 months in patients from the Rybrevant combination group versus 4.2 months in the carboplatin-pemetrexed group. The confirmed ORR was 53% and 29% in the Rybrevant combination and carboplatin-pemetrexed groups.

During a second interim analysis of OS, researchers reported that the OS was not statistically significant, with 85% of the deaths needed for the final analysis.

Regarding safety, the most common side effects that occurred in at least 20% or more patients included rash, infusion-related reactions, nail toxicity, nausea, fatigue, constipation, edema (swelling caused by fluid in tissues), stomatitis (inflammation of the mouth and lips), decrease in appetite, musculoskeletal pain (pain to the muscles or joints), vomiting and COVID-19 infection.

Recommended doses of Rybrevant plus carboplatin and pemetrexed is based on body weight at baseline, according to the alert.

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