Beigenes has released results from their Phase III RATIONALE 309 clinical trial of its Tislelizumab and chemotherapy combination treatment for nasopharyngeal cancer patients (NPC).
The Tislelizumab treatment involves an anti-PD-1 monoclonal antibody which may potentially lower binding to Fc gamma receptors on macrophages. The trial’s clinical protocol involved a randomized, double-blind, placebo-controlled trial to compare the safety and efficacy of the antibody in combination with chemotherapy, and without it in recurrent or metastatic NPC patients.
In total 263 participants were enrolled, all in Asia. The primary endpoint of progression-free survival was met in the interim data analysis. The new treatment in conjunction with chemotherapy resulted in a statistically significant improvement in progression free survival when compared to the placebo arm.
During the trial, no new safety signals were detected when the treatment was combined with chemotherapy. Yong Ben, the Beigene Immuno-Oncology chief medical officer, expressed his excitement for the clinically meaningful results and stated in an interview with Clinical trials arena: “This is our fifth positive Phase III readout for tislelizumab, which we are developing broadly as a potentially differentiated anti-PD-1 antibody.”
The treatment has market authorization from the China National Medical Products Administration, and is also being researched for use in classical Hodgkin’s lymphoma and locally advanced or metastatic urothelial carcinoma.
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