New Reference: Tislelizumab with Chemotherapy for Nasopharyngeal Carcinoma

The RATIONALE-309 trial demonstrated that tislelizumab plus chemotherapy provided sustained progression-free survival and numerical overall survival improvements compared to placebo plus chemotherapy in recurrent or metastatic nasopharyngeal carcinoma. While progression-free survival improvement was modest, the overall survival benefit was significant. Safety profile was consistent with known immune-related risks.

Study

Double-blind, placebo-controlled phase 3 randomized clinical trial [RATIONALE-309]

Recurrent or metastatic nasopharyngeal carcinoma, treatment-naive

Tislelizumab+chemotherapy (CISplatin – gemcitabine) (n=131) vs placebo+chemotherapy (n=132)

Efficacy

mPFS: 9.6 mos vs 7.4 mos (HR 0.53 [0.39-0.71])

mOS: 45.3 mos vs 31.8 mos (HR 0.73 [0.51-1.05])

Safety

Grade >=3 AEs: 85.0% vs 85.4%

Serious AEs: 35.3% vs 35.4%

Treatment discontinuations: 16.5% vs 10.8%

Immune-mediated AEs (any grade): 53.4% vs 37.7%

JAMA Oncol. Published online February 26, 2026

Yang Y, Yen CJ, Pan J First-Line Tislelizumab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Cancer: Three-Year Follow-Up of the Phase 3 RATIONALE-309 Randomized Clinical Trial

http://doi.org/10.1001/jamaoncol.2026.0020

Reviewed by Ulas D. Bayraktar, MD on Mar 12, 2026

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