Johnson & Johnson Reports the EC’s Approval of Rybrevant (Amivantamab) Plus Lazcluze (Lazertinib) as a 1L Treatment of EGFRm NSCLC 

Shots:     

• The EC has approved Rybrevant + Lazcluze as a 1L treatment of advanced NSCLC harboring EGFR exon 19 deletions (ex19del) or exon 21 L858R substitution mutations. The EC’s decision of lazertinib for the corresponding combination regimen is pending (was granted CHMP’s recommendation last month) 

• Approval was based on P-III (MARIPOSA) trial assessing Rybrevant + Lazcluze vs osimertinib or Lazcluze alone as a 1L treatment of locally advanced or metastatic NSCLC patients (n=1,074) with EGFR ex19del or L858R substitution mutations 

• Study achieved its 1EP of PFS, showing reduced risk of disease progression or death by 30% vs osimertinib, with mPFS of 23.7 vs 16.6mos. (at 22mos. median follow-up) & mDoR of 25.8 vs 16.8mos. (9mos. improvement) 

Ref:  Johnson & Johnson | Image:  Johnson & Johnson| Press Release

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