FDA Approves Amivantamab Plus Carboplatin, Pemetrexed for Certain Patients With NSCLC

The US Food and Drug Administration has approved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) plus carboplatin and pemetrexed for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations. The approval is for patients whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.

The efficacy was evaluated in the randomized, open-label, multicenter MARIPOSA-2 trial. The trial included 657 patients who had locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations. All patients had disease progression on or after receiving osimertinib. The study investigators randomized patients 1:2:2 to receive amivantamab-vmjw with carboplatin and pemetrexed, carboplatin and pemetrexed, or amivantamab-vmjw as part of another combination regimen.

The primary efficacy outcome measure in MARIPOSA was progression-free survival (PFS) as assessed by a blinded independent central review for the comparison between amivantamab plus carboplatin and pemetrexed versus carboplatin and pemetrexed. The median PFS was 6.3 months in patients receiving amivantamab plus carboplatin and pemetrexed, significantly longer than the median PFS in those receiving carboplatin and pemetrexed (hazard ratio [HR] 0.48; P<.0001).

The confirmed overall response rate was 55% in patients receiving amivantamab plus carboplatin and pemetrexed, compared with 29% in those receiving carboplatin and pemetrexed (P<.0001). No statistically significant difference was observed in overall survival (OS) between the two groups at the prespecified second interim analysis of OS. The stratified OS HR was 0.73.

The most common adverse reactions, occurring in at least 20% of patients, were rash, infusion-related reactions, fatigue, nail toxicity, nausea, constipation, edema, stomatitis, decreased appetite, musculoskeletal pain, vomiting, and COVID-19 infection.

The recommended amivantamab-vmjw dose is based on baseline body weight. Full prescribing information will be posted on Drugs@FDA.

Source: FDA