Authors
Harry H Yoon, Ken Kato, Eric Raymond, Richard Hubner, Yongqian Shu, Yueyin Pan, Sook Ryun Park, Takashi Kojima, Chen-Yuan Lin, Lucjan Wyrwicz, David Tougeron, Ryu Ishihara, Kaijun Wang, Yanyan Peng, Jianming Xu
Published in
Nature communications. Volume 17. Issue 1. Sep 03, 2026. Epub Sep 03, 2026.
Abstract
RATIONALE-306 previously demonstrated improved overall survival (OS) in participants treated with tislelizumab plus chemotherapy versus those receiving placebo plus chemotherapy as first-line treatment for advanced/metastatic esophageal squamous cell carcinoma, with a minimum follow-up of approximately 15 months. Exploratory long-term efficacy, safety, and quality of life (QoL) analyses after 36.0 months' minimum follow-up are reported here. Patients (649) were randomized 1:1 to tislelizumab 200 mg or placebo with investigator-chosen chemotherapy. Tislelizumab plus chemotherapy improves OS versus placebo plus chemotherapy in all patients (17.2 versus 10.6 months; hazard ratio, 0.70; 95% confidence interval, 0.59-0.80). At 3 years, 15.0% of patients treated with tislelizumab plus chemotherapy had not progressed versus 2.9% of those receiving placebo plus chemotherapy. No new safety signals have been identified. Median time to deterioration of physical functioning-a key QoL domain-has not been reached with tislelizumab plus chemotherapy versus 18.8 months with placebo plus chemotherapy. With longer follow-up, tislelizumab plus chemotherapy demonstrates long-lasting efficacy, tolerable safety, and favorable patient-reported outcomes, making it a suitable option for this patient population. ClinicalTrials.gov: NCT03783442 .
PMID:
42834033
Bibliographic data and abstract were imported from PubMed on 06 Oct 2026.
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