Three-year follow-up results from the Phase 3 RATIONALE-309 trial show that adding tislelizumab to chemotherapy significantly improves survival in patients with recurrent or metastatic nasopharyngeal carcinoma.
Patients receiving the combination of tislelizumab with chemotherapy lived longer and had better disease control compared to chemotherapy alone. Median progression-free survival was 9.6 months versus 7.4 months, while median overall survival reached 45.3 months compared to 31.8 months.
The study included 326 patients who had not received prior treatment. They were given tislelizumab or placebo every three weeks along with chemotherapy drugs gemcitabine and cisplatin. Patients in the placebo group were allowed to switch to tislelizumab if their cancer worsened.
Further analysis showed that patients with higher B-cell–related gene activity experienced even greater survival benefits, suggesting a potential biomarker for predicting response.
In terms of safety, most patients in both groups experienced side effects, with similar rates of serious events. Immune-related side effects were more common in the tislelizumab group but were mostly mild.
Overall, the combination of tislelizumab and chemotherapy provides a clear and lasting survival benefit, supporting its use as an effective treatment option for advanced nasopharyngeal cancer.