Janssen Submits sBLA to FDA for Amivantamab-vmjw in Osimertinib-Resistant EGFR-Mutant NSCLC

On November 20, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, announced that it had submitted a supplemental Biologics License Application (sBLA) to the FDA for amivantamab-vmjw (Rybrevant), an EGFR/c-Met bispecific antibody, for use in combination with chemotherapy to treat patients with EGFR-mutated non-small cell lung cancer (NSCLC) whose disease has progressed during or after treatment with osimertinib.

This sBLA is primarily based on the positive data from the Phase III MARIPOSA-2 study. The study is a randomized, open-label Phase III clinical trial designed to evaluateAmivantamab-vmjw + Lazertinib + Carboplatin + Pemetrexed (LACP)Plan andCarboplatin + Pemetrexed (CP)Efficacy and safety of the regimen in EGFR common mutation (Exon19 del/Exon21 L858R) locally advanced or metastatic NSCLC patients with resistance to Osimertinib. Meanwhile, the study also set aACP Regimen Group, namely Amivantamab-vmjw + Carboplatin + Pemetrexed Group, to evaluate the treatment effect of adding lazertinib in the regimen. The primary endpoint of the study is progression-free survival (PFS).

The results showed that the study met its primary endpoint, meaning that compared with the CP regimen group, the PFS of patients in both the LACP regimen group and the ACP regimen group was prolonged with statistical and clinical significance. In terms of safety, it was consistent with previous studies, and no new safety signals were observed.

PFS Assessed by BICR (Source: 2023 ESMO Congress)

Amivantamab-vmjw was first approved by the FDA in May 2021 for the treatment of patients with advanced or metastatic NSCLC carrying EGFR exon 20 insertion mutations after platinum-based chemotherapy progression. This drug is also the world's first approved EGFR/c-MET bispecific antibody.

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