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BMS’ Opdivo Receives the EC’s Approval as a Perioperative Treatment of Resectable NSCLC

Shots:

  • The EC has approved Opdivo + CT as neoadj. therapy followed by surgery & adj. Opdivo alone to treat adults with resectable NSCLC at high risk of recurrence & PD-L1 expression ≥1% in all 30 EEA states
  • Approval was based on P-III (CheckMate-77T) study assessing neoadj. Opdivo + CT vs neoadj. PBO & CT followed by surgery & adj. Opdivo alone vs PBO in 461 pts with resectable stage IIA to IIIB NSCLC
  • Trial met its 1EP of EFS, with a 42% reduced risk of recurrence, progression, or death after 25.4mos. mFU & 65% vs 44% pts achieving EFS after 24mos., while 2EPs showed improved pCR & MPR; OS remains under assessment. Updated data was shared at ESMO 2024, with EFS, pCR & MPR data published in The NEJM 

Ref: BMS | Image: BMS| Press Release

Related News:- BMS Reports Topline P-III (ARISE) Trial Data of Cobenfy as an Adjunctive Therapy for Schizophrenia

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