TEVIMBRA Safety Guidelines: Managing Infusion Reactions and Potential Risks

Managing TEVIMBRA Infusion Reactions

For moderate (Grade 2) infusion-related reactions, it is advised to interrupt the infusion of TEVIMBRA. In cases of severe (Grade 3) or life-threatening (Grade 4) reactions, the infusion should be stopped immediately, and TEVIMBRA should be permanently discontinued.

Complications Post Allogeneic HSCT

Patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) before or after treatment with a PD-1/PD-L1 blocking antibody like TEVIMBRA may experience fatal or serious complications. These include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease, and steroid-requiring febrile syndrome. Such complications can occur despite any intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Close monitoring for transplant-related complications is essential, and the benefits and risks of using a PD-1/PD-L1 blocking antibody should be carefully considered.

Potential Embryo-Fetal Toxicity

TEVIMBRA may cause fetal harm if administered to pregnant women due to its mechanism of action. Animal studies suggest that inhibiting the PD-1/PD-L1 pathway can increase the risk of immune-mediated rejection of the fetus, leading to fetal death. Women of reproductive potential should be advised of these risks and use effective contraception during treatment and for four months after the last dose.

Adverse Reactions and Dosage Adjustments

Permanent discontinuation of TEVIMBRA due to adverse reactions occurred in 19% of patients, with hemorrhage, pneumonitis, and pneumonia being the most common reasons. Dosage interruptions were necessary for 23% of patients, primarily due to pneumonia, pneumonitis, and fatigue. Common adverse reactions (≥ 20%) included increased glucose, decreased hemoglobin, decreased lymphocytes, decreased sodium, decreased albumin, increased alkaline phosphatase, anemia, fatigue, increased AST, musculoskeletal pain, decreased weight, increased ALT, and cough.

About BeiGene

BeiGene is a global oncology company focused on developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a diverse pipeline of novel therapeutics, BeiGene is committed to improving access to medicines for patients in need. The company operates with a global team of over 10,000 colleagues across five continents. For more information, visit www.beigene.com and follow BeiGene on LinkedIn, X (formerly Twitter), Facebook, and Instagram.

Forward-Looking Statements

This release includes forward-looking statements regarding BeiGene’s ability to expand TEVIMBRA's availability in the U.S., and its plans and goals. Actual results may differ due to various factors, including regulatory actions, clinical trial outcomes, and the company's ability to secure funding and protect intellectual property. For more detailed risk information, refer to BeiGene’s recent filings with the U.S. Securities and Exchange Commission. BeiGene is under no obligation to update these statements unless required by law.