BeiGene announced that the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA ® (tislelizumab) as a treatment for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have previously received unresectable or metastatic esophageal squamous cell carcinoma (ESCC). Monotherapy after systemic chemotherapy containing a PD-(L)1 inhibitor. TEVIMBRA will be launched in the U.S. market in the second half of 2024.

Dr. Mark Lanasa, chief medical officer of solid tumors at BeiGene, said: "The FDA today approved TEVIMBRA for patients with ESCC who have previously received chemotherapy. At the same time, the FDA is reviewing the biologics license application (BLA) for first-line ESCC patients. This is our commitment to An important step in bringing this therapy to more patients around the world. As the first drug candidate produced by BeiGene’s immuno-oncology program and the second drug approved in the U.S., TEVIMBRA will be the first drug candidate produced by BeiGene’s solid tumor development program. Key pillar. The project covers more than 17 registered clinical trials in more than 30 countries/regions around the world."

The approval builds on the RATIONALE 302 trial, which met its primary endpoint in the intention-to-treat (ITT) population. TEVIMBRA 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 TEVIMBRA arm and 6.3 months (95% CI: 5.3, 10.4) in the chemotherapy arm. 7.0) (p=0.0001; hazard ratio [HR]=0.70 [95% CI: 0.57, 0.85]). 

TEVIMBRA has a better safety profile than chemotherapy. i The most common (≥20%) adverse reactions with TEVIMBRA include laboratory abnormalities such as increased glucose, decreased hemoglobin, decreased lymphocytes, decreased sodium, decreased albumin, increased alkaline phosphatase, anemia, fatigue, and alanine aminotransferase Elevated alanine aminotransferase, musculoskeletal pain, weight loss, elevated alanine aminotransferase, and cough. i

"Patients are diagnosed with advanced or metastatic ESCC, the most common histological subtype of esophageal cancer," said Dr. Syma Iqbal, associate professor of clinical medicine and chief physician of medical oncology and cancer at the Keck School of Medicine of USC's Norris Comprehensive Cancer Center. Progression often occurs after initial treatment, requiring new options. The RATIONALE 302 trial showed that patients with previously treated ESCC achieved a clinically meaningful survival benefit when receiving TEVIMBRA, highlighting its potential as an important treatment option for these patients."

Tisleliziz was approved by the European Commission for the treatment of advanced or metastatic ESCC in 2023, and received a positive evaluation from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use in February 2024, as a non-small cell drug for three indications. Cell lung cancer treatment drugs.

The FDA is also reviewing a biologics license application for tisleliz as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC and for patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. (BLA). The target action times are July and December 2024 respectively.