FDA approves BeiGene’s TEVIMBRA for esophageal cancer treatment

In a notable advancement in the oncology sector, BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a globally recognized oncology company, has received approval from the U.S. Food and Drug Administration (FDA) for TEVIMBRA (tislelizumab-jsgr). This approval marks a significant milestone for TEVIMBRA as a monotherapy in the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have previously undergone systemic chemotherapy excluding a PD-(L)1 inhibitor. TEVIMBRA is expected to be available in the U.S. market in the second half of 2024, presenting a new hope for patients battling this challenging condition.

Dr. Mark Lanasa, M.D., Ph.D., the Chief Medical Officer for Solid Tumors at BeiGene, highlighted the FDA’s approval as a pivotal step in their ongoing efforts to extend the reach of their therapies to patients worldwide. TEVIMBRA stands out as BeiGene’s first drug candidate from its immuno-oncology program and its second medicine to receive approval in the U.S. With over 17 registration-enabling clinical trials across more than 30 countries, BeiGene’s solid tumor development program is robust and expansive, indicating a strong commitment to advancing cancer treatment globally.

The FDA’s approval was largely influenced by the results of the RATIONALE 302 trial, which met its primary endpoint by demonstrating a statistically significant and clinically meaningful survival benefit of TEVIMBRA over chemotherapy. Patients treated with TEVIMBRA experienced a median overall survival (OS) of 8.6 months compared to 6.3 months for those on chemotherapy, showcasing the drug’s potential to significantly improve patient outcomes.

Dr. Syma Iqbal, M.D., from the Norris Comprehensive Cancer Center, emphasized the urgent need for new treatment options for patients with advanced or metastasized ESCC, the most common subtype of esophageal cancer. The RATIONALE 302 trial’s findings reveal TEVIMBRA’s capability to offer a clinically meaningful survival benefit, positioning it as a valuable addition to the treatment arsenal for this patient group.

Besides the recent FDA approval, TEVIMBRA received the green light from the European Commission for the treatment of advanced or metastatic ESCC after prior chemotherapy in 2023. Moreover, the European Medicines Agency (EMA) has expressed a positive opinion on TEVIMBRA for non-small cell lung cancer across three indications in February 2024. These approvals underscore TEVIMBRA’s potential to make a significant impact on cancer treatment worldwide.

With over 900,000 patients globally having been prescribed TEVIMBRA, BeiGene’s extensive clinical trial program underscores the drug’s potential to deliver significant improvements in survival and quality of life across various tumor types, both as monotherapy and in combination with other regimens. The company’s vision of extending the benefits of TEVIMBRA to a broader patient population is well on its way to becoming a reality, signifying a promising future in the fight against cancer.

The FDA’s approval of TEVIMBRA represents a leap forward in the treatment of esophageal squamous cell carcinoma. By offering a new therapeutic option for patients who have limited choices post-chemotherapy, BeiGene is reinforcing its position as a leader in the development of innovative cancer treatments. The clinical success of TEVIMBRA also highlights the importance of continued research and development in immuno-oncology, potentially paving the way for breakthroughs in the treatment of other types of cancer.