Sugemalimab Approved to Treat Adult Patients with Non-Small Cell Lung Cancer
London, UK – October 30, 2024 – UK News and Communications reports that Sugemalimab, a PD-1 monoclonal antibody, has been approved by the National Institute for Health and Care Excellence (NICE) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received prior platinum-based chemotherapy.
The approval is based on results from the Phase III GEMSTONE-301 trial, which showed that Sugemalimab improved progression-free survival (PFS) and overall survival (OS) compared to docetaxel in patients with previously treated NSCLC.
In the trial, patients were randomized to receive Sugemalimab or docetaxel. The median PFS was 7.8 months in the Sugemalimab arm and 5.6 months in the docetaxel arm (HR=0.73; p=0.0005). The median OS was 15.8 months in the Sugemalimab arm and 13.0 months in the docetaxel arm (HR=0.82; p=0.0069).
Sugemalimab was well tolerated in the trial. The most common adverse events were fatigue, diarrhea, rash, and nausea.
Mechanism of Action
Sugemalimab is a humanized monoclonal antibody that blocks the PD-1 immune checkpoint protein. PD-1 is expressed on the surface of T cells and other immune cells, and it inhibits T cell activation and proliferation. By blocking PD-1, Sugemalimab allows T cells to more effectively recognize and kill cancer cells.
Significance of the Approval
The approval of Sugemalimab is a significant advance in the treatment of NSCLC. It is the first PD-1 inhibitor to be approved for the treatment of previously treated NSCLC, and it has shown to improve PFS and OS compared to docetaxel.
Sugemalimab is expected to become a standard of care for patients with previously treated NSCLC. It is likely to be used in combination with other therapies, such as chemotherapy or targeted therapy.
About Non-Small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. It accounts for about 85% of all lung cancers. NSCLC is typically diagnosed in people who are over the age of 50 and have a history of smoking.
The symptoms of NSCLC can include:
- A persistent cough
- Shortness of breath
- Chest pain
- Coughing up blood
- Weight loss
- Fatigue
About Sugemalimab
Sugemalimab is a humanized monoclonal antibody that blocks the PD-1 immune checkpoint protein. It is approved for the treatment of adult patients with locally advanced or metastatic NSCLC who have received prior platinum-based chemotherapy.
Sugemalimab is administered as an intravenous infusion every three weeks. The recommended dose is 200 mg.
Sugemalimab approved to treat adult patients with non-small cell lung cancer
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