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BeOne Medicine’s Perioperative Tevimbra (Tislelizumab) Receives the EC’s Approval for Resectable NSCLC

Shots:

  • The EC has approved neoadj. Tevimbra + Pt-based CT followed by adj. Tevimbra monotx. for adults with resectable NSCLC at high risk of recurrence
  • Approval was based on P-III (RATIONALE-315) trial assessing perioperative Tevimbra with CT before surgery vs PBO + CT in NSCLC pts (n=453), which met its dual 1EPs of EFS & major pathologic response at interim analyses, also published in The Lancet Respiratory Medicine & presented at ESMO’24
  • Final analysis (mFU of 38.5mos.) showed Tevimbra + CT improved OS, EFS, MPR & pCR, with sustained EFS benefit (HR 0.58), consistent across IRC & investigator assessments; OS & EFS benefits were consistent across subgroups, irrespective of PD-L1, disease stage, or histology; data to be presented at WCLC’25

Ref: Beone Medicine | Image: Beone Medicine | Press Release

Related News:- Royalty Pharma Signs Agreement to Acquire Interest in Amgen’s Imdelltra Royalties from BeOne Medicines for ~$950M

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