Shots:

• The approval was based on the P-III (RATIONALE 309) study evaluating the efficacy & safety of tislelizumab + gemcitabine & cisplatin vs PBO + gemcitabine & cisplatin in 256 patients with recurrent or metastatic NPC
• The trial met its 1EPs of PFS at the planned interim analysis. In updated efficacy analyses at a median follow-up of 15.5mos., tislelizumab + CT showed PFS benefit, positive trend in OS & improvement in time to disease progression or death after next-line therapy
• The safety profile was manageable & consistent with the safety profiles of each treatment agent & the results were presented at ASCO 2022. The 2EPs include ORR ORR, DoR, OS, PFS, time to second objective disease progression, and safety

Ref: Businesswire Image: BeiGene