Press Release
Press Release
The addition of tislelizumab to chemotherapy significantly extended OS for patients with previously untreated advanced esophageal squamous cell carcinoma, according to a press release from the agent’s manufacturer.
The combination conferred the survival benefit among patients with unresectable, locally advanced, recurrent or metastatic disease regardless of PD-L1 expression, an interim analysis of the randomized phase 3 RATIONALE 306 study showed. It also had a safety profile consistent with that observed in previous trials.
“We are encouraged by the survival benefit seen in the tislelizumab and chemotherapy group in RATIONALE 306. We have designed an expansive clinical development program, with a global scope, to investigate tislelizumab as a potential treatment for solid tumors, and it is rewarding to deliver the seventh positive phase 3 pivotal trial to demonstrate benefit with tislelizumab treatment,” Mark Lanasa, MD, chief medical officer for solid tumors at BeiGene, said in a company-issued press release.
Tislelizumab (BGB-A317, BeiGene), a humanized immunoglobulin G4 anti-PD-1 monoclonal antibody, is designed to minimize binding to Fc gamma receptors on macrophages, which may result in anti-PD-1 resistance. The treatment has shown efficacy in several tumor types in phase 2 and 3 trials.
The RATIONALE 306 trial evaluated tislelizumab with chemotherapy vs. chemotherapy alone among 649 patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma. OS served as the primary endpoint, with PFS, objective response rate, duration of response, health-related quality of life measures and safety as secondary endpoints.
Novartis, which holds the rights to develop, manufacture and commercialize the agent in North America, Europe and Japan, plans to submit the data to regulatory officials and collaborate with BeiGene to present them at a future medical meeting.
“People living with esophageal cancer experience painful everyday challenges and typically have a poor prognosis, with a 5-year survival rate of around 5% for metastatic cases, underscoring the urgency for more immunotherapy options,” Jeff Legos, executive vice president and global head of oncology and hematology development for Novartis, said in a Novartis press release. “We plan to discuss these data with health authorities, and we will continue to expand our tislelizumab clinical development program in pursuit of novel, synergistic combinations with the ultimate goal of extending survival for more patients.”
Global phase 3 trial of BeiGene’s PD-1 inhibitor, tislelizumab, in combination with chemotherapy meets primary endpoint in first-line advanced esophageal squamous cell carcinoma (press release). ir.beigene.com/news/global-phase-3-trial-of-beigene-s-pd-1-inhibitor-tislelizumab-in-combination-with-chemotherapy-meets-primary/c094ebdc-5bfb-4f42-a6f9-5b214ade9b16/. Published April 27, 2022. Accessed April 27, 2022.
Novartis tislelizumab plus chemotherapy significantly improved overall survival as first-line treatment for advanced esophageal cancer in Phase III study (press release). www.novartis.com/news/media-releases/novartis-tislelizumab-plus-chemotherapy-significantly-improved-overall-survival-first-line-treatment-advanced-esophageal-cancer-phase-iii-study. Published April 27, 2022. Accessed April 27, 2022.
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