Updated results from phase III RATIONALE-309 trial of PD-1 Inhibitor tislelizumab
Updated results from phase III RATIONALE-309 trial of PD-1 Inhibitor tislelizumab in first-line RM-NPC(nasopharyngeal cancer) in virtual ASCO plenary series.
BeiGene announced the presentation of updated data analyses from the Phase III RATIONALE-309 trial of tislelizumab, a humanized anti-PD-1 monoclonal antibody, in combination with chemotherapy versus chemotherapy plus placebo as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (RM-NPC), at the virtual American Society of Clinical Oncology (ASCO) Plenary Series on April 19, 2022.
Updated efficacy analyses showed that, at a median follow-up of 15.5 months, tislelizumab in combination with chemotherapy continued to demonstrate a clinically significant progression-free survival (PFS) benefit over chemotherapy alone for patients with RM-NPC. The safety profile of the tislelizumab and chemotherapy combination was generally manageable and consistent with known risks of each treatment agent.
An updated analysis of the primary endpoint (PFS) and two secondary endpoints (PFS2, OS) was performed based on the latest database cutoff as of September. 30, 2021. At a median follow-up of 15.5 months, patients administered a 200 mg dose of tislelizumab in combination with chemotherapy achieved a median PFS of 9.6 months (stratified hazard ratio (HR)=0.50 [CI: 0.37, 0.68]) compared to 7.4 months for patients dosed with placebo control and chemotherapy, as assessed by an independent review committee (IRC).
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