Originally published by our sister publication Clinical Oncology News

By Clinical Oncology News Staff

The FDA has approved amivantamab-vmjw (Rybrevant, Janssen Biotech) with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.

Efficacy was evaluated in MARIPOSA-2 (ClinicalTrials.gov. Identifier: NCT04988295), a multicenter, randomized, open-label trial in 657 patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations and disease progression on or after receiving osimertinib. Patients were randomized (1:2:2) to receive amivantamab-vmjw with carboplatin and pemetrexed (amivantamab + CP), carboplatin and pemetrexed (CP), or amivantamab-vmjw as part of another combination regimen.


The major efficacy outcome measure was progression-free survival (PFS) as assessed by blinded independent central review (BICR) for the comparison between amivantamab + CP and CP. Overall response rate (ORR) per BICR and overall survival (OS) were key secondary outcome measures. Median PFS was 6.3 months (95% CI, 5.6-8.4 months) in the amivantamab + CP arm and 4.2 months (95% CI, 4.0-4.4 months) in the CP arm (hazard ratio, 0.48; 95% CI, 0.36-0.64; (P<0.0001). The confirmed ORR was 53% (95% CI, 44%-62%) in the amivantamab + CP arm and 29% (95% CI, 23%-35%) in the CP arm (P<0.0001).

At the pre-specified second interim analysis of OS, with 85% of the deaths needed for the final analysis, there was no statistically significant difference in OS between treatment arms. The stratified OS hazard ratio was 0.73 (95% CI, 0.54-0.99).

The most common adverse reactions (≥20%) were rash, infusion-related reactions, fatigue, nail toxicity, nausea, constipation, edema, stomatitis, decreased appetite, musculoskeletal pain, vomiting and COVID-19 infection.

The full prescribing information for Rybrevant will be posted at a later date here. 

Based on a press release from the FDA.