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
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