BeiGene, Ltd, an international oncology company, which has preliminarily decided to rebrand itself as BeOne Medicines Ltd, announced that its developed drug, Tevimbra (tislelizumab-jsgr) was approved by the U.S Food and Drug Administration (FDA).
The FDA approval of this drug, Tevimbra, occurred as the first-line treatment in combination with fluoropyrimidine-based and platinum chemotherapy for human epidermal growth factor receptor 2 (HER2)-negative, programmed death-ligand 1 (PD-L1) ≥1 of adults with unresectable or metastatic gastric(G)/gastroesophageal junction (GEJ) adenocarcinoma.
Chief medical officer for Solid Tumors, Mark Lanasa, MD, Ph.D., BeiGene, began his presentation by stating that this approval is a big step towards BeiGene’s vision that transforming the lives of cancer patients through innovative and transformative therapies. This was done after the completion of the RATIONALE-305 trial a multi-center, phase 3, double-blind, randomized, placebo-controlled trial.
The trial reached the primary end, demonstrating, clinical improvement and statistically significant in overall survival (OS). Patients were administered Tevimbra along with the choice of chemotherapy determined by the investigator, with a median OS of 15.0 months, whereas the patient given a placebo plus chemotherapy had a median OS of 12.9 months (n=997; hazard ratio (HR): 0.80 [95% confidence interval (CI): 0.70,0.92]; P = 0.0011). This resulted in death risk reduction of 20%.
The safety data for Tevimbra was assessed based on 1,972 patients who participated in various clinical trials. These included two randomized, open-label, active-control studies (RATIONALE-302 and BGB-A317-303) and five open-label, single-arm studies (BGB-A317-102, BGB-A317-203, BGB-A317-204, BGB-A317-208, and BGB-A317_Study_001). Of these participants, 307 had esophageal squamous cell carcinoma (ESCC), while 1,665 had advanced or recurrent disease. Commonly reported Grade 3 or 4 adverse drug reactions (ADRs) associated with Tevimbra use, particularly in combination with chemotherapy includes neutropenia, hypokalemia, fatigue,anemia, thrombocytopenia, hyponatremia, pneumonia, anorexia, rash, lymphopenia, elevated ALT and AST, hepatitis, pneumonitis and diarrhea.
Tevimbra has already been approved in the United States as a monotherapy for adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who previously underwent systemic chemotherapy. Additionally, it is use as a first-line treatment for locally advanced, unresectable, or metastatic ESCC is being evaluated under a separate biologics license application (BLA) submitted by BeiGene.
Tevimbra is a humanized recombinant IgG4 anti-PD-1 monoclonal antibody with excellent selectivity for its target with a high affinity to PD-1. They reduce binding to Fc-gamma receptors thus improving the immune system’s ability to recognize and destroy tumors. This design is critical to its ability to serve as one of the core treatments offered by BeiGene in its solid tumor treatments.
Tevimbra clinical program has 66 trials in 34 countries with patient enrolment up to 14,000 as of date. Tevimbra has been approved in over 42 countries and over 1.3 million patients have taken Tevimbra. Its success reflects BeiGene’s potential efforts to develop fundamental treatment for multiple tumor types across the country.
This name change plan of BeiGene to BeOne Medicines Ltd bears testimony to its commitment to international cooperation and accessibility towards its treatment for cancer. It works in internal and external aspects of development for new therapeutics which are novel in the field of pharmacology.
BeiGene’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products.
This press release contains forward-looking statements under the Private Securities Litigation Reform Act of 1995, BeiGene’s efforts to present cancer therapies, Tevimbra’s potential in the field of oncology, future approvals, and plans. Actual results may differ significantly from those anticipated because of clinical outcomes, regulatory actions, and drug efficacy and safety can be affected by such factors.
With the FDA approval of Tevimbra for the treatment of G/GEJ cancer, the company gains an innovative solution that can revolutionize the therapy of cancer patients. BeiGene has a strong clinical development, and the company has been advancing the development of a new cancer treatment more effectively and efficiently in meeting unmet global patient needs. The nature of the company’s operations, rebranding activities, and strategic plans today prepare it for the development of the company in the future years.
Reference: Ryan C. Tislelizumab Plus Chemotherapy Receives FDA Approval for First-Line Treatment of Advanced Gastric Cancer. OncLive. Published December 27, 2024. Accessed  Tislelizumab Plus Chemotherapy Receives FDA Approval for First-Line Treatment of Advanced Gastric Cancer
