FDA Approves Tislelizumab for Advanced ESCC Based on Positive Study Findings

The US Food and Drug Administration has approved tislelizumab-jsgr (Tevimbra) with platinum-containing chemotherapy for the treatment of advanced esophageal squamous cell carcinoma (ESCC) in patients whose tumors express PD-L1 (≥1).

The approval is based on positive results from the phase III RATIONALE-306 study, which analyzed the combination in 649 patients against placebo with chemotherapy. The study met its primary endpoint of overall survival (OS), and the combination demonstrated a manageable safety profile.

An analysis of OS in 481 PD-L1 positive (≥1) patients showed a median OS of 16.8 months for patients treated with tislelizumab-jsgr plus chemotherapy compared to 9.6 months for patients treated with placebo plus chemotherapy (HR: 0.66, [95% CI: 0.53, 0.82]), resulting in a 34% reduction in the risk of death.

Tislelizumab-jsgr is currently approved for use in the US as a monotherapy treatment for patients with advanced ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor and in combination with chemotherapy for the first-line treatment of patients with gastric and gastroesophageal cancers.