Sugemalimab is an immunotherapy drug that harnesses the body’s own immune system to combat cancer. It functions as a monoclonal antibody, a laboratory-produced protein designed to target specific substances in the body. This drug enhances the immune response against malignant cells to treat certain types of cancer.
Understanding Sugemalimab’s Action
Sugemalimab operates by interacting with the programmed cell death-ligand 1 (PD-L1) protein, often found on the surface of tumor cells. Cancer cells use PD-L1 to bind with the programmed cell death protein 1 (PD-1) on immune cells, specifically T cells, which “switches off” the T cells’ ability to recognize and destroy them. By blocking this interaction, sugemalimab reactivates the T cells.
This blockade removes the inhibitory signals that prevent T cells from attacking cancer cells. When sugemalimab binds to PD-L1, it stops the cancer from deactivating immune cells, thereby increasing the immune system’s capacity to kill tumor cells.
Cancers Treated by Sugemalimab
Sugemalimab has demonstrated effectiveness in treating several types of cancer. It is approved in China for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) without specific EGFR mutations or ALK/ROS1/RET genomic tumor aberrations. In these cases, it is administered in combination with platinum-based chemotherapy.
The drug is also approved in China for the first-line treatment of gastric or gastroesophageal junction (G/GEJ) adenocarcinoma in combination with chemotherapy, making it the first anti-PD-L1 monoclonal antibody approved for this indication globally. Additionally, sugemalimab has received approval in China for relapsed or refractory extranodal natural killer/T-cell lymphoma (ENKTL) and esophageal squamous cell carcinoma (ESCC). Clinical studies are ongoing to explore its potential in other solid tumors, including liver cancer and Hodgkin lymphoma.
Receiving Treatment and Managing Effects
Sugemalimab is administered intravenously, given as a drip into a vein. The infusion takes about 60 minutes and is given every three weeks, though the treatment schedule can vary based on individual patient needs. This administration occurs in a hospital or clinic setting under the supervision of a medical professional.
Patients undergoing treatment with sugemalimab may experience various side effects. Common ones include fatigue, decreased appetite, and gastrointestinal issues such as nausea, vomiting, or diarrhea. Skin reactions like rash, itching, or dryness are also observed. These common side effects are often managed with supportive care, such as antiemetic medications for nausea or dietary adjustments for diarrhea.
Less common but more serious side effects can involve changes in blood parameters, such as a decrease in red blood cell count or alterations in liver enzyme levels. Some patients may experience imbalances in blood levels of substances like calcium, potassium, or sodium. Immune-related adverse events, where the immune system attacks healthy tissues, can occur and may affect organs like the lungs (pneumonitis), liver (hepatitis), or kidneys (nephritis). Any unusual or severe symptoms should be reported to a healthcare provider promptly for appropriate management.
Sugemalimab’s Current Status
Sugemalimab, known by the brand name Cejemly, has received regulatory approvals, particularly in China. It was initially approved in December 2021 in China for the first-line treatment of metastatic non-small cell lung cancer. Since then, its indications in China have expanded.
Beyond China, sugemalimab has also gained approval in Europe by the European Commission for the first-line treatment of metastatic non-small cell lung cancer, marking its first international approval. The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has accepted a marketing authorization application for sugemalimab for metastatic NSCLC, which is currently under review. Clinical trials are ongoing in various regions, including the US and Australia, exploring its potential in other cancer types.