Tislelizumab extends OS in advanced NSCLC
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Tislelizumab prolonged OS compared with docetaxel for patients with advanced non-small cell lung cancer, according to topline data released by the agent’s manufacturer.
Tislelizumab (BGB-A317, BeiGene) is a humanized immunoglobulin G4 anti-PD-1 monoclonal antibody.
The randomized phase 3 RATIONALE 303 trial included 805 patients with locally advanced or metastatic NSCLC who progressed on platinum-based chemotherapy.
Researchers assigned patients from 10 countries 2:1 to tislelizumab or docetaxel as second- or third-line treatment.
Primary endpoints included OS in the intention-to-treat population and OS among patients with high PD-L1 expression. Key secondary endpoints included objective response rate, duration of response, PFS and safety.
Results of a planned interim analysis showed improved OS with tislelizumab in the intention-to-treat population.
The safety profile of tislelizumab appeared consistent with known risks of the agent. Researchers observed no new safety signals.
Complete results of the trial will be presented at a medical conference.
“The RATIONALE 303 trial is the third phase 3 trial of tislelizumab in NSCLC that has achieved a positive outcome at interim analysis and, more importantly, marks the first global pivotal trial with a positive outcome in the tislelizumab clinical program,” Yong (Ben) Ben, MD, BeiGene’s chief medical officer for immuno-oncology, said in a company-issued press release.
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