BeiGene Reports the NMPA’s Acceptance of sBLA for Tislelizumab for 1L Treatment of Hepatocellular Carcinoma
- 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
Related News:- BeiGene Entered into a Clinical Supply Agreement with Phanes Therapeutics to Evaluate PT199 + Tislelizumab for Multiple Advanced Solid Tumors
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at [email protected].