On October 30, Pfizer announced that the third indication for its PD-L1 monoclonal antibody, Sugemalimab, received conditional approval from the National Medical Products Administration (NMPA) for monotherapy to treat adult patients with relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL).As the world's firstPD-L1 monoclonal antibody for the treatment of R/R ENKTL,SugelLidunabWill change the clinical landscape in the R/R ENKTL field where there is currently no standard treatment.Dilemma.Since 20Since the end of 2021,SugoldLidunanHave been approved in China for two indications in the field of non-small cell lung cancer.This approval is based on the results of the GEMSTONE-201 study, which aimed to evaluateSugelLidunanEfficacy and safety as a single-agent treatment for adult patients with R/R ENKTL.Lymphoma is a common malignant tumor in China, with about 101,500 new cases and 47,000 deaths annually. Extranodal NK/T-cell lymphoma (ENKTL) is a subtype of mature T-cell and NK-cell lymphomas, and its incidence rate is significantly higher in Asian populations compared to Europe and North America. In China, the incidence of ENKTL accounts for approximately 6% of all lymphoma subtypes and 28% of mature T-cell and NK-cell lymphomas.With the mainstream adoption of asparaginase-based chemotherapy regimens as the first-line treatment for ENKTL, clinical outcomes for patients have improved to a certain extent. However, approximately 50% of patients will progress to the refractory or relapsed stage within 5 years. The median survival for R/R ENKTL patients is only about 6 months, with a 1-year survival rate typically less than 20%. Currently, there is no standard treatment regimen available for such patients.SugemLidunabGEMSTONE-201 Principal Investigator, Professor Huang Huiqiang from the Sun Yat-sen University Cancer Center, stated: "The GEMSTONE-201 study is, to date, the largest sample-sized registrational clinical trial for PD-L1 monoclonal antibody treatment in R/R ENKTL, and its primary endpoint results demonstrate...SugelLidunan"This will change the treatment landscape for patients with R/R ENKTL at this stage, providing them with a standard treatment option. We also look forward to this drug being quickly applied in clinical practice to help more patients gain access to a new treatment choice."Copyright © 2023 PHARMCUBE. All Rights Reserved.
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