On December 21, Johnson & Johnson announced that it had submitted a new indication marketing application for the EGFR/c-MET bispecific antibody Rybrevant (Amivantamab-vmjw) to the U.S. FDA and the European EMA, seeking regulatory approval.Amivantamab-vmjwCombination of Third-Generation EGFR Inhibitor Lazertinib as First-Line Treatment for Patients with EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC).This application is primarily based on data from the pivotal Phase III MARIPOSA study, which aims to evaluate the efficacy and safety of Amivantamab-vmjw in combination with Lazertinib (A+L) compared to third-generation EGFR TKI monotherapy (Osimertinib) and Lazertinib as first-line treatments for EGFR-positive advanced NSCLC. The trial enrolled a total of 1,074 patients, who were randomly assigned in a 2:2:1 ratio to the A+L group, Osimertinib group, and Lazertinib group.The results showed that the MARIPOSA study met its primary endpoint, with statistically significant and clinically meaningful improvement in progression-free survival (PFS) in the A+L treatment group compared to the osimertinib treatment group. Additionally, compared to the osimertinib treatment group, the A+L treatment group demonstrated a trend toward overall survival (OS) benefit. In terms of safety, the safety profile of the A+L combination was consistent with previously reported data.Previously, Johnson & Johnson had submitted 2 items to the FDAAmivantamab-vmjwSupplemental Biologics License Application (sBLA), IndicationBevacizumab in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with EGFR-mutated locally advanced or metastatic NSCLC (August this year), and in combination with chemotherapy for patients with EGFR-mutated NSCLC whose disease has progressed during or after treatment with osimertinib (November this year).Copyright © 2023 PHARMCUBE. All Rights Reserved.
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