Summary
BeiGene, Ltd. (ONC) announced significant clinical data at the American Association for Cancer Research (AACR) Annual Meeting 2021, highlighting the potential of its anti-PD-1 antibody, tislelizumab. The company presented data from a Phase 1b trial evaluating tislelizumab in combination with sitravatinib (jointly developed with Mirati Therapeutics) in patients with advanced melanoma resistant to PD-1/L1 inhibitors and in patients with advanced platinum-resistant ovarian cancer. These presentations offer insights into potential new treatment avenues for difficult-to-treat patient populations. Furthermore, BeiGene shared interim analysis results from the Phase 3 RATIONALE 303 trial, comparing tislelizumab to docetaxel for second- or third-line non-small cell lung cancer (NSCLC). These positive results have already led to the acceptance of a supplemental biologics application in China, currently under regulatory review. This progress in NSCLC, a major oncology indication, is a key development for the company's commercial efforts.
Key Highlights
- 1Presentation of clinical data for tislelizumab in combination with sitravatinib at AACR 2021.
- 2Data focused on difficult-to-treat patient populations: PD-1/L1 refractory melanoma and platinum-resistant ovarian cancer.
- 3Interim analysis results from the Phase 3 RATIONALE 303 trial for tislelizumab in NSCLC were presented.
- 4Tislelizumab demonstrated potential against docetaxel in second- or third-line NSCLC therapy.
- 5A supplemental biologics application for tislelizumab based on RATIONALE 303 results has been accepted in China.
- 6The NSCLC application is currently under regulatory review in China.