Tislelizumab extended OS compared with chemotherapy for patients with previously treated advanced esophageal squamous cell carcinoma, according to topline data released by the agent’s manufacturer.
Tislelizumab (BGB-A317, BeiGene) is humanized immunoglobulin G4 anti-PD-1 monoclonal antibody designed to minimize binding to Fc gamma receptors on macrophages.
The randomized phase 3 RATIONALE 302 trial included 512 patients from North America, Europe or Asia with advanced unresectable or metastatic esophageal squamous cell carcinoma who received prior systemic treatment.
Researchers assigned patients to tislelizumab or the investigator’s choice of paclitaxel, docetaxel or irinotecan. The trial met its primary endpoint, with results showing a statistically significant improvement in OS with tislelizumab in the intention-to-treat population. Tislelizumab exhibited a safety profile consistent with prior reports. Researchers observed no new safety signals.
“Esophageal cancer represents a significant unmet medical need with rapid progression and high mortality,” Lin Shen, MD, vice president of clinical oncology at Beijing Cancer Hospital and lead investigator for the RATIONALE 302 trial, said in a BeiGene-issued press release. “Recent years have seen a paradigm shift in advanced [esophageal squamous cell carcinoma] treatment from chemotherapy and radiation to immunotherapy. The positive topline results from the RATIONALE 302 trial demonstrated that tislelizumab may offer a new treatment option for those living with this devastating disease and bring hope to patients and their families.”
Complete results of the trial will be submitted for presentation at a medical conference and shared with health authorities.
“This is our fourth positive phase 3 readout for tislelizumab and the first from our large phase 3 program in gastrointestinal cancers,” Yong (Ben) Ben, MD, chief medical officer for immuno-oncology with BeiGene, said in the release. “With our ongoing evaluation of tislelizumab across multiple tumor types, we are working to provide clinical evidence and bring this potentially differentiated anti-PD-1 antibody to far more patients around the world.”
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