Tislelizumab significantly prolonged progression-free survival (PFS) compared to placebo in patients with recurrent or metastatic nasopharyngeal cancer (RM-NPC), according to data from the RATIONALE 309 trial presented at the European Society for Medical Oncology Immuno-Oncology Congress 2021.
“We are pleased that tislelizumab in combination with chemotherapy demonstrated a statistically significant progression-free survival benefit for patients with RM-NPC over chemotherapy,” said Yong (Ben) Ben, MD, chief medical officer, Immuno-Oncology at BeiGene, in a press release. “A filing based on these results is currently under review in China, where NPC as an endemic disease remains a significant unmet medical need. We look forward to continued discussions with the health authority and are working to bring this important immunotherapy to patients in China as soon as we can.”
RATIONALE 309 is a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial designed to evaluate the efficacy and safety of tislelizumab in combination with gemcitabine and cisplatin (arm A) compared to placebo combined with gemcitabine and cisplatin (arm B) as a first-line treatment for patients with RM-NPC. PFS as assessed by an independent review committee (IRC) was the primary endpoint in the intent-to-treat (ITT) population, with secondary endpoints including IRC-assessed overall response rate (ORR), IRC-assessed duration of response (DoR), overall survival (OS), investigator-assessed PFS, time to second objective disease progression (PFS2), and safety.
At a median follow-up of 10 months, RATIONALE 309 achieved the primary endpoint at the interim analysis, with the combination of tislelizumab and chemotherapy demonstrating a statistically significant improvement in PFS. Median PFS in arm A was 9.2 months versus 7.4 months in the placebo arm. Consistent PFS benefits were observed in most subgroups, including disease status, baseline liver metastases, and gender. Further, The ORR and complete response (CR) rate were 69.5% and 16.0% in arm A, compared to 55.3% and 6.8% in arm B.
“In the RATIONALE 309 trial, the addition of tislelizumab to chemotherapy significantly prolonged PFS for previously untreated patients with RM-NPC, an aggressive head and neck cancer prevalent in Asia, with consistent survival benefit across patient subgroups,” said Yunpeng Yang, MD, Professor at Sun Yat-sen University Cancer Center and principal investigator of the study, in the release “Safety results in both arms remained similar to known risks and no new safety signals were identified. The promising results support the potential of tislelizumab in combination with chemotherapy as a new standard of care in China for the first-line treatment of RM-NPC.”
BeiGene presents results from phase 3 trial of tislelizumab in nasopharyngeal cancer at ESMO Immuno-Oncology Congress 2021 [news release]. BeiGene; December 10, 2021. Accessed December 10, 2021. https://www.businesswire.com/news/home/20211210005022/en