Shots:
- The CHMP has recommended Rybrevant + Lazcluze as a 1L treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations and approval of Type II extension of indication for amivantamab
- Opinion was based on the P-III (MARIPOSA) study assessing Rybrevant + Lazcluze vs osimertinib & Lazcluze in NSCLC patients (n=1,074)
- Trial achieved its 1EP, showing a 30% reduced disease progression or death risk (mPFS: 23.7 vs 16.6mos.) at 22mos. follow-up & mDoR of 25.8 vs 16.8mos. It also included serial brain MRIs to detect CNS events & depicted mPFS of 27.5 vs 18.4mos.; long-term follow-up (31.1mos.) showed a favorable OS trend, with 61% vs 53% alive, mOS not estimable [NE] vs 37.3mos.
Ref: Johnson & Johnson| Image: Johnson & Johnson | Press Release
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