Shots:
- The EC has approved Tevimbra (tislelizumab) + gemcitabine & cisplatin for 1L treatment of adults with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy
- Approval was based on P-III (RATIONALE-309) trial assessing Tevimbra + gemcitabine & cisplatin vs PBO + gemcitabine & cisplatin in 263 treatment-naïve NPC pts
- Trial met its 1EP with prolonged PFS in the ITT population, showing a 48% reduction in risk of progression or death & mPFS of 9.2 vs 7.4mos.; additional 12mos. follow-up showed consistent results with improved OS (mOS: 45.3 vs 31.8mos.)
Ref: Businesswire | Image: BeOne Medicines| Press Release
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