BeiGene, a global biotechnology company, has shared encouraging outcomes from its Phase 3 RATIONALE 309 trial evaluating tislelizumab in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (RM-NPC). The trial demonstrated a statistically significant improvement in progression-free survival (PFS) compared to chemotherapy alone, with benefits observed across various patient subgroups.
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Trial Design and Results: The RATIONALE 309 trial is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial involving 263 patients. It compared the efficacy and safety of tislelizumab combined with gemcitabine and cisplatin against placebo combined with the same chemotherapy. The primary endpoint was PFS, with secondary endpoints including overall response rate (ORR), duration of response (DoR), and overall survival (OS).
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Key Findings: As of March 26, 2021, with a median follow-up of 10.0 months, the combination of tislelizumab and chemotherapy showed a median PFS of 9.2 months versus 7.4 months for the placebo group. The PFS rate at six, nine, and twelve months was significantly higher in the tislelizumab group. Additionally, the ORR and complete response rate were notably higher in the tislelizumab arm.
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Safety Profile: The safety profile of the tislelizumab and chemotherapy combination was manageable and consistent with the known risks of each treatment agent. The most common treatment-emergent adverse events included anemia, decreased white blood cell count, and nausea.
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Regulatory Status: Following these positive results, a supplemental Biologics License Application (sBLA) for tislelizumab in this indication is under review in China, highlighting the potential of this combination as a new standard of care for RM-NPC patients.
Nasopharyngeal cancer (NPC) is a significant health burden in China, with an estimated 62,555 new cases in 2020. The disease is associated with genetic predisposition, Epstein-Barr virus infection, and dietary factors, presenting a high unmet medical need for effective treatments.
Tislelizumab, an anti-PD-1 monoclonal antibody, is part of BeiGene's immuno-oncology program and has shown promise in treating various cancers. Its development underscores BeiGene's commitment to advancing innovative and affordable medicines for patients worldwide.
