BeiGene, a prominent global biotechnology company, has recently shared positive regulatory updates regarding its innovative cancer therapy, Tevimbra (tislelizumab), in Europe and the United States. This exciting development follows BeiGene's recent regaining of global rights for Tevimbra.
European Commission Approves Tevimbra for ESCC
The European Commission (E.C.) has approved Tevimbra as a monotherapy for treating adult patients with unresectable, locally advanced, or metastatic esophagal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy. This significant decision by the E.C. aligns with the positive recommendation from the Committee for Medicinal Products for Human Use. It is based on the compelling results from BeiGene's RATIONALE 302 study.
The RATIONALE 302 study, a global Phase 3 trial (NCT03430843), involved 513 patients across 11 countries in Europe, Asia, and North America. It aimed to evaluate the efficacy and safety of Tevimbra compared to the investigator's choice of chemotherapy as a second-line treatment for ESCC. Importantly, RATIONALE 302 demonstrated a statistically significant and clinically meaningful survival benefit with Tevimbra, with a median overall survival of 8.6 months compared to 6.3 months with chemotherapy.
The safety profile of Tevimbra in this study remained consistent with previous trials, affirming its favourable risk-benefit profile.
U.S. FDA Accepts Biologics License Application for Tevimbra as a first - line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC.
Simultaneously, the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC. This critical milestone in the regulatory process has set a target action date in the second half of 2024 under the Prescription Drug User Fee Act.
The FDA's acceptance of the BLA is supported by findings from RATIONALE 306 (NCT03783442), a global Phase 3 trial investigating the efficacy and safety of tislelizumab in combination with chemotherapy as a first-line treatment for advanced or metastatic ESCC. Additionally, the FDA has granted tislelizumab Orphan Drug Designation (ODD) to treat previously untreated advanced or metastatic ESCC.
Tevimbra represents a promising step forward in the fight against ESCC and potentially other cancer types.