Sintilimab is an immunotherapy drug used in the treatment of various cancers. It works by harnessing the body’s own immune system to identify and combat cancer cells. This medication represents a significant advancement in oncology, offering a different approach compared to traditional cancer therapies.
Mechanism of Action
Sintilimab functions as a monoclonal antibody that specifically targets and binds to the programmed cell death protein 1 (PD-1) receptor. This receptor is found on the surface of T-cells, a type of immune cell. Cancer cells often exploit the PD-1 pathway by expressing ligands like PD-L1, which bind to PD-1 and effectively “turn off” the T-cells, preventing them from recognizing and attacking the tumor.
By blocking the interaction between PD-1 and its ligands (PD-L1 and PD-L2), sintilimab helps to reactivate these T-cells. The drug essentially removes the “brake” that cancer cells place on the immune system, enabling T-cells to identify and destroy malignant cells more effectively. This mechanism positions sintilimab within a class of drugs known as immune checkpoint inhibitors.
Approved Medical Uses
Sintilimab has received regulatory approval for the treatment of several specific cancer types. It is indicated for classical Hodgkin lymphoma in patients who have relapsed or are refractory after receiving at least two lines of systemic chemotherapy.
For non-small cell lung cancer (NSCLC), sintilimab is approved for use in combination with chemotherapy for the first-line treatment of non-squamous NSCLC. It is also approved for hepatocellular carcinoma (liver cancer) when used in combination with bevacizumab biosimilar for patients who have not received prior systemic therapy.
Approved indications also include esophageal squamous cell carcinoma, particularly in combination with chemotherapy as a first-line treatment. It is also used for gastric or gastroesophageal junction adenocarcinoma, often in combination with chemotherapy. Additionally, it has an indication for renal cell carcinoma (kidney cancer) when used in combination with axitinib for advanced cases.
How Sintilimab is Administered
Sintilimab is administered intravenously, directly into a patient’s vein through an infusion. This process takes place in a hospital or specialized clinic setting, under the supervision of healthcare professionals. The typical dosage is 200 mg given every three weeks.
Each infusion session ranges from 30 to 60 minutes. The dosing schedule and treatment duration vary based on the patient’s condition and response. Healthcare providers monitor patients during and after the infusion to ensure safety and manage any immediate reactions.
Common and Serious Side Effects
Patients receiving sintilimab may experience a range of side effects, some of which are common and generally manageable, while others can be more serious. Common side effects include fatigue, skin rash, nausea, and fever. Other common side effects include thyroid dysfunction or elevated liver enzymes.
More serious side effects, known as immune-related adverse events, can occur due to the drug’s effect on the immune system. These involve inflammation of various organs, such as the lungs (pneumonitis), liver (hepatitis), kidneys (nephritis), and endocrine glands like the thyroid or adrenal glands. These immune-related events require prompt medical attention. Patients should report any new or worsening symptoms to their healthcare provider without delay, as early intervention can help manage these reactions effectively.
Global Approvals and Access
Sintilimab, known by the brand name Tyvyt, was co-developed by Innovent Biologics and Eli Lilly and Company. It first received regulatory approval in China. The National Medical Products Administration (NMPA) of China approved sintilimab in 2018 for certain indications.
While sintilimab is widely approved in China, its status in other major markets like the United States and Europe differs. In the United States, sintilimab has been under investigation for various solid tumors, including non-small cell lung cancer. Its availability and access outside of China depend on specific regulatory approvals in each country.