J&J scores first-line approval for Rybrevant combo in lung cancer

01 Mar 2024
firstwordpharma.com
Clinical ResultPhase 3Drug ApprovalAccelerated Approval
The FDA said Friday that it approved Johnson & Johnson's Rybrevant (amivantamab-vmjw) for use in combination with chemotherapy as a front-line treatment for non-small-cell lung cancer (NSCLC). Specifically, the new indication, based on data from the Phase III PAPILLON trial, is to treat locally advanced or metastatic disease in NSCLC patients with EGFR exon 20 insertion mutations.
The bispecific antibody, which has activity against both EGFR- and MET-driven disease, also received traditional approval as a single agent for patients who have received prior platinum chemotherapy. The FDA had granted an accelerated approval for this indication back in 2021.
The filing last year contained data from the PAPILLON study, in which Rybrevant plus carboplatin and pemetrexed showed a significant 60% benefit on progression-free survival (PFS), compared to carboplatin and pemetrexed alone in previously untreated patients with EGFR Exon 20 insertion mutation-positive NSCLC. Median PFS was 11.4 months with the combination therapy, compared to 6.7 months for chemotherapy alone.
"While [overall survival] results were immature at the current analysis, with 44% of pre-specified deaths for the final analysis reported, no trend towards a detriment was observed," the FDA noted. The indication is also under review by EU regulators.
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