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Harry H. Yoon, MD, discusses updated findings from the phase 3 RATIONALE-306 trial in esophageal squamous cell carcinoma.
Harry H. Yoon, MD, co-chair, Esophageal/Gastric Cancer Disease Group, Mayo Clinic Cancer Center, discusses updated findings from the phase 3 RATIONALE-306 trial (NCT03783442) in esophageal squamous cell carcinoma (ESCC).
The placebo-controlled, double-blind trial randomized patients to evaluate the efficacy and safety of tislelizumab (BGB-A317) plus chemotherapy vs placebo plus chemotherapy in the first-line treatment of patients with advanced unresectable/metastatic ESCC.
Tislelizumab plus chemotherapy achieved a significantly improved overall survival (OS) compared with placebo and chemotherapy, Yoon says. The median OS in the tislelizumab arm was 17 months vs 10 months in the placebo arm with a hazard ratio of 0.66, Yoon explains. Additionally, the OS benefit was observed in all patients in the tislelizumab arm, irrespective of PD-L1 status, Yoon notes. OS benefits were not affected by geographic regions or choice of chemotherapy, Yoon explains.
Additionally, tislelizumab plus chemotherapy significantly improved progression-free survival and response rates, and the combination produced a notable duration of response and a reasonable safety profile, Yoon concludes.