On March 15, 2024, BeiGene announced that the U.S. Food and Drug Administration (FDA) has approved tislelizumab (Chinese trade name: BAIZEAN®; English trade name: TEVIMBRA®) as mono-therapy to treat adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy (without PD-1/L1 inhibitors). Tislelizumab is expected to be available in the United States in the second half of 2024.

The approval was based on results from the RATIONALE 302 trial, which met its primary endpoint in the intention-to-treat (ITT) population. Tislelizumab demonstrated a statistically significant and clinically meaningful survival benefit compared with chemotherapy. In the ITT population, median overall survival (OS) was 8.6 months (95% CI: 7.5, 10.4) in the tislelizumab group compared with 6.3 months (95% CI: 5.3, 7.0) in the chemotherapy group (p=0.0001; hazard ratio [HR]=0.70 [95% CI: 0.57, 0.85]). The safety profile of tislelizumab is superior to that of chemotherapy. The most common (≥20%) adverse reactions of tislelizumab (including abnormal laboratory test results) are increased glucose, decreased hemoglobin, decreased lymphocytes, decreased sodium, decreased albumin, and increased alkaline phosphatase , anemia, fatigue, elevated aspartate aminotransferase, musculoskeletal pain, weight loss, elevated alanine aminotransferase, and cough.

Tislelizumab has been approved by the European Commission in 2023 to treat patients with advanced or metastatic ESCC who have previously received chemotherapy. In February 2024, tislelizumab received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending its approval for the treatment of three non-small cell lung cancer indications.

The FDA is also currently evaluating tislelizumab as the first-line treatment of patients with unresectable, recurrent, locally advanced or metastatic ESCC, and for the treatment of locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/ GEJ) adenocarcinoma patient's new drug marketing authorization application (BLA) for review. The FDA is expected to make decisions on these two BLAs in July and December 2024 respectively.

BeiGene has conducted more than 17 potential registration clinical trials of tislelizumab, of which 11 phase III randomized trials and 4 phase II trials have achieved positive results. These trial results show that tislelizumab, as a monotherapy or in combination with other drugs, can provide safe, clinically meaningful survival benefits and quality of life for hundreds of thousands of patients across multiple cancer types. And in many cases, benefit can be seen regardless of patient's PD-(L)1 expression status. To date, more than 900,000 patients worldwide have received tislelizumab treatment.

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