Dr Uboha on the FDA Approval of First-Line Tislelizumab Plus Chemotherapy for Metastatic ESCC

"This approval allows our patients to access additional options for treatment...Patients with this disease have a very poor prognosis. [ESCC is] incurable in the metastatic setting, and we definitely need more and better treatment options for patients with this disease." 

Nataliya Uboha, MD, PhD, a medical oncologist at University of Wisconsin Health, as well as an associate professor and researcher in the Department of Medicine at the University of Wisconsin School of Medicine and Public Health, discusses the significance of the FDA approval of tislelizumab-jsgr (Tevimbra) in combination with chemotherapy​ for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC).

On March 4, 2025, the FDA approved tislelizumab in combination with platinum-containing chemotherapy for the first-line treatment of adult patients with unresectable or metastatic ESCC with a tumor PD-L1 expression of at least 1​. This regulatory decision was supported by findings from ​​the phase 3 RATIONALE-306 trial (NCT03783442). At a median follow-up of 16.3 months (interquartile range [IQR], 8.6-21.8), the median overall survival (OS) was 17.2 months (95% CI, 15.8-20.1) among patients who received tislelizumab plus chemotherapy (n = 326). In comparison, at a median follow-up of 9.8 months (IQR, 5.8-19.0), the median OS among patients who received placebo plus chemotherapy (n = 323) was 10.6 months (95% CI, 9.3-12.1; stratified HR, 0.66 [95% CI, 0.54-0.80; 1-sided P < .0001]). In the subgroup of patients with PD-L1 expression of 1 or higher, the median OS was 16.8 months (95% CI, 15.3-20.8) with tislelizumab plus chemotherapy (n = 231) vs 9.6 months (95% CI, 8.9-11.8) with placebo plus chemotherapy (n = 250; HR, 0.66; 95% CI, 0.53-0.82).

The approval of tislelizumab plus chemotherapy gives patients with ​metastatic ESCC access to an additional treatment option, which is important given the typically poor prognosis associated with this aggressive disease, Uboha begins. Metastatic ESCC is currently incurable, highlighting the need for more effective regimens in the treatment arsenal, she adds. Furthermore, many patients with this disease have significant symptom burden and many comorbidities, emphasizing the importance of ensuring that these agents are tolerable, she concludes.