BeiGene’s PD-1 inhibitor, Tislelizumab, represents an advancement in cancer treatment. This targeted therapy, developed by BeiGene, leverages the body’s own immune system to combat malignant cells. Its purpose in oncology is to offer a new approach for various cancer types.
Understanding PD-1 and Immunotherapy
The immune system uses checkpoints to prevent attacking healthy cells. One such checkpoint involves the protein Programmed Death-1 (PD-1) on immune cells like T-cells. When PD-1 binds to its partner proteins, PD-L1 or PD-L2, on other cells, it sends an “off” signal, preventing the T-cell from launching an immune response.
Cancer cells exploit this mechanism by overexpressing PD-L1, binding to PD-1 on T-cells, and effectively “turning off” the immune attack. Tislelizumab, a humanized monoclonal antibody, specifically binds to the PD-1 receptor, blocking its interaction with PD-L1 and PD-L2. By blocking this interaction, Tislelizumab removes the “off” switch, allowing T-cells to remain active and recognize cancer cells more effectively. This enables the immune system to mount an anti-tumor response and potentially reduce tumor growth. Tislelizumab was also engineered to minimize binding to Fcγ receptors on macrophages, which can sometimes compromise the anti-tumor activity of PD-1 antibodies.
Approved Cancer Treatments
BeiGene’s PD-1 inhibitor, Tislelizumab (marketed as Tevimbra), has received regulatory approvals for treating several specific cancer types in various regions. In the United States, the Food and Drug Administration (FDA) has approved Tislelizumab for esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction adenocarcinoma. For ESCC, it is approved as a single agent for unresectable or metastatic cases after prior systemic chemotherapy that did not include a PD-1/PD-L1 inhibitor, and in combination with platinum-based chemotherapy as a first-line treatment for adults with unresectable or metastatic ESCC whose tumors express PD-L1.
For gastric or gastroesophageal junction adenocarcinoma, Tislelizumab is approved in combination with platinum and fluoropyrimidine-based chemotherapy as a first-line treatment for unresectable or metastatic HER2-negative cases with PD-L1 expression. In Europe, the European Commission (EC) has approved Tislelizumab for use in non-small cell lung cancer (NSCLC) across three indications. This includes use in combination with carboplatin and either paclitaxel or nab-paclitaxel as a first-line treatment for squamous NSCLC, and in combination with pemetrexed and platinum-containing chemotherapy as a first-line therapy for non-squamous NSCLC.
Tislelizumab is also approved as a monotherapy for locally advanced or metastatic relapsed NSCLC in Europe. In China, the National Medical Products Administration (NMPA) has granted approvals for Tislelizumab in eight indications, including multiple approvals in NSCLC.
Potential Side Effects
Like all cancer treatments, Tislelizumab can cause side effects, ranging from common and manageable to more serious, immune-related adverse events. Patients commonly experience general side effects such as fatigue, anemia, musculoskeletal pain, decreased weight, nausea, vomiting, diarrhea, constipation, decreased appetite, cough, and fever.
More serious side effects, known as immune-mediated adverse reactions, can occur because Tislelizumab activates the immune system. These reactions can affect various organ systems, including the lungs (pneumonitis), colon (colitis), liver (hepatitis), and endocrine glands (endocrinopathies like hypothyroidism). Skin reactions, such as rash and itching, can also occur, sometimes with blistering or peeling. Patients should promptly report any new or worsening symptoms to their healthcare providers, as immune-mediated side effects can sometimes be severe or life-threatening and may manifest weeks to months after starting treatment or even after discontinuation.
Availability and Regulatory Status
BeiGene’s Tislelizumab is currently available in several major markets following regulatory approvals. In China, the National Medical Products Administration (NMPA) has approved Tislelizumab for eight different indications. In the United States, the U.S. Food and Drug Administration (FDA) has granted approval for Tislelizumab (marketed as Tevimbra) for specific indications.
The European Medicines Agency (EMA) has also accepted marketing authorization applications for Tislelizumab, with the European Commission (EC) having approved it for three NSCLC indications. BeiGene is actively pursuing additional regulatory reviews and approvals for Tislelizumab globally, including an ongoing collaboration with Novartis to accelerate its development and marketing in North America, Europe, and Japan.