The sBLA was based on a P-III study (RATIONALE 301) evaluating tislelizumab vs sorafenib in a ratio (1:1) in 674 patients with unresectable HCC from research centers across Asia, the EU & the US
The trial met its 1EPs of non-inferiority for OS; m-OS (15.9 vs 14.1mos.), favorable safety profile with no new safety signals, incidence rates of grade ≥3 AEs (48.2% vs 65.4%), AEs leading to discontinuation (10.9% vs 18.5%), OS results were consistent across pre-specified subgroups, ORR (14.3% vs 5.4%) with more durable responses, m-DoR (36.1 vs 11.0mos.), m-PFS (2.1 vs 3.4mos.), median treatment duration (4.1 vs 2.7mos.). The results were presented at ESMO 2022
Tislelizumab (IgG4 anti-PD-1 mAb) was approved in China for 9 indications, incl. conditional approval for HCC
Ref: PRNewswire | Image: BeiGene
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