By Fineline Cube 
US giant Johnson & Johnson (J&J, NYSE: JNJ) announced that China’s National Medical Products Administration (NMPA) has approved a new indication for Rybrevant (amivantamab) in combination with Lazcluze (Lazertinib) for the treatment of patients with EGFR-mutant progressive or recurrent non-small cell lung cancer (NSCLC). This approval expands the therapeutic options for patients with this aggressive form of lung cancer.
Mechanism and Previous Approvals
Amivantamab is an EGFR-MET bispecific antibody (BsAb) previously approved for use in combination with carboplatin and pemetrexed as a first-line treatment for locally advanced or metastatic NSCLC in adult patients with the EGFR exon 20 insertion mutation. It is also approved for use in combination with carboplatin and pemetrexed for patients with locally advanced or metastatic non-squamous NSCLC who have experienced disease progression during or after EGFR tyrosine kinase inhibitor (TKI) therapy. Lazertinib, a third-generation EGFR TKI, complements amivantamab by enhancing the suppression of disease progression in advanced NSCLC with EGFR mutations, effectively addressing the complexity and heterogeneity of acquired resistance mechanisms.
Clinical Trial Results
The approval of this chemo-free regimen is based on the results of the Phase 3 MARIPOSA trial. Compared to osimertinib, the combination of amivantamab and lazertinib demonstrated a 30% reduction in the risk of disease progression or death, with a median progression-free survival (PFS) of 23.7 months, significantly surpassing the osimertinib group’s 16.6 months. The safety profile of the combination therapy aligns with previous reports, with adverse events predominantly graded 1-2 and occurring mainly within the first four months of treatment. Long-term follow-up has not identified any new safety signals.-Fineline Info & Tech