Emily Menendez

DocwireNews

The US Food and Drug Administration has approved tislelizumab-jsgr (Tevimbra) with platinum-containing chemotherapy <a href="https://hkexir.beigene.com/news/tevimbra-approved-in-u-s-for-first-line-treatment-of-advanced-esophageal-squamous-cell-carcinoma-in-combination/8379a7c3-35ce-45af-82d3-164c64ecf37c/" target="_blank" rel="noopener">for the treatment of advanced esophageal squamous cell carcinoma</a> (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.

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The FDA has approved tislelizumab-jsgr with platinum-containing chemotherapy for the treatment of advanced esophageal squamous cell carcinoma.

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