BeiGene a global oncology Chemotherapy company that plans to rebrand itself as BeOne Medicines Ltd., has achieved a significant milestone with the U.S. Food and Drug Administration’s (FDA) approval of TEVIMBRA® (tislelizumab-jsgr). This approval pertains to its use in combination with platinum and fluoropyrimidine-based chemotherapy as a first-line treatment for unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adult patients whose tumors express PD-L1 (≥1).
“Today’s FDA approval of TEVIMBRA for the treatment of gastric or gastroesophageal Chemotherapy junction cancers in PD-L1 positive adult patients marks a significant step forward in our mission to deliver transformative therapies to patients with cancer,” stated Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. He added, “This is the second U.S. approval for TEVIMBRA this year, underscoring its potential to address critical needs in oncology. We remain deeply grateful to the patients, clinicians, and researchers whose commitment and courage have made this progress possible—and we look forward to building on this momentum in 2025.”
Clinical Evidence Supporting Approval
The approval is supported by data from BeiGene’s RATIONALE-305 trial (NCT03777657), a pivotal Phase 3 study that evaluated the efficacy and safety of TEVIMBRA combined with chemotherapy as a first-line treatment for advanced unresectable or metastatic G/GEJ cancers. This randomized, double-blind, placebo-controlled, global study demonstrated statistically significant and clinically meaningful improvements in overall survival (OS). Patients treated with TEVIMBRA and chemotherapy achieved a median OS of 15.0 months, compared to 12.9 months for those receiving placebo and chemotherapy (n=997; HR: 0.80 [95% CI: 0.70, 0.92]; P=0.0011). This represents a 20% reduction in the risk of death.
Beyond efficacy, the safety profile of TEVIMBRA was extensively studied. The application’s pooled safety data included findings from 1,972 patients across several trials, including two randomized, open-label, active-controlled studies (RATIONALE-302 and BGB-A317-303) and five single-arm, open-label studies. These trials involved 307 patients with esophageal squamous cell carcinoma (ESCC) and 1,665 patients with advanced or recurrent tumors. The most common Grade 3 or 4 adverse reactions observed with TEVIMBRA in combination with chemotherapy included neutropenia, thrombocytopenia, anemia, fatigue, hypokalemia, hyponatremia, pneumonia, decreased appetite, rash, lymphopenia, increased levels of alanine and aspartate aminotransferase, diarrhea, pneumonitis, and hepatitis.
Combination with Chemotherapy
In addition to its recent FDA approval, TEVIMBRA is already approved in the U.S. as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma who have previously undergone systemic chemotherapy that did not include a PD-(L)1 inhibitor. Furthermore, an additional Biologics License Application (BLA) for TEVIMBRA is currently under FDA review for the first-line treatment of adult patients with locally advanced unresectable or metastatic ESCC.
This approval is a significant step forward in addressing the pressing needs of patients with G/GEJ cancers. HER2-negative gastric and gastroesophageal junction cancers represent a challenging disease area with limited treatment options. The addition of TEVIMBRA to the treatment landscape offers a new standard of care, providing a survival advantage and reinforcing BeiGene’s commitment to delivering innovative cancer therapies.
RATIONALE-305, the study underpinning the FDA’s decision, exemplifies BeiGene’s dedication to robust clinical research. This trial enrolled a diverse global patient population, ensuring the findings are applicable to a wide range of individuals affected by G/GEJ cancers. The study design included rigorous evaluation of both efficacy and safety outcomes, ensuring a comprehensive understanding of TEVIMBRA’s benefits and risks when used alongside chemotherapy. The trial’s positive outcomes underscore the importance of advancing immunotherapy as a cornerstone of modern oncology treatment strategies.
TEVIMBRA’s mechanism of action involves targeting the programmed death receptor-1 (PD-1) pathway, an essential checkpoint in the immune system that can be exploited by cancer cells to evade immune detection. By inhibiting this pathway, TEVIMBRA restores the immune system’s ability to recognize and attack tumor cells. This mechanism, combined with chemotherapy’s cytotoxic effects, creates a synergistic treatment approach that has shown promise in improving patient outcomes.
The safety data collected from nearly 2,000 patients across multiple studies provide a comprehensive understanding of TEVIMBRA’s risk profile. While the treatment offers substantial benefits, it is associated with a range of adverse effects, many of which are common in immunotherapy and chemotherapy regimens. Healthcare providers must carefully monitor patients receiving TEVIMBRA to manage potential side effects effectively, ensuring that the benefits of treatment outweigh the risks.
BeiGene’s decision to rebrand as BeOne Medicines Ltd. reflects a broader commitment to its mission of eradicating cancer globally. The company’s emphasis on collaboration and innovation is evident in its development of TEVIMBRA and other pipeline therapies. By working with international researchers, clinicians, and patient communities, BeiGene aims to accelerate the development of transformative cancer treatments and make them accessible to as many patients as possible.
TEVIMBRA’s dual approvals in the U.S. within a single year highlight the rapid advancements BeiGene has achieved in oncology. These milestones signify not only the effectiveness of TEVIMBRA but also the company’s capability to navigate the complex regulatory environment, bringing innovative therapies to market efficiently. Looking ahead, BeiGene’s ongoing clinical trials and pending regulatory submissions are expected to further solidify its position as a leader in oncology innovation.
The additional approval of TEVIMBRA for G/GEJ cancers reinforces its potential to become a foundational therapy in oncology. This achievement also marks a significant milestone in the broader landscape of cancer immunotherapy, showcasing the transformative impact of PD-1 inhibitors in treating a variety of solid tumors. BeiGene’s work exemplifies the critical role of targeted therapies in addressing unmet medical needs and improving patient survival outcomes.
As the company prepares to transition to its new identity as BeOne Medicines Ltd., its commitment to patients remains unwavering. By focusing on innovative research and global collaboration, BeiGene aims to redefine cancer care and improve the lives of patients worldwide. The approval of TEVIMBRA for G/GEJ cancers is a testament to this mission, offering hope and new possibilities to individuals battling these challenging diseases. With its robust pipeline and dedication to oncology, BeiGene is poised to make even greater strides in the fight against cancer in the years to come.
