On September 14, the NMPA website showed that MSD's PD-1 inhibitorPembrolizumab New Indication Approved for Marketing(Application No.: JXSS2300083), speculated to be used for treatmentPatients with MSI-H/dMMR advanced endometrial cancer，These patients experienced disease progression after systemic treatment in any setting and are not candidates for curative surgery or radiotherapy.
Screenshot source: NMPA official websiteThis approval is based on a Phase II clinical trial conducted in China.(Registration Number:CTR20200103）, the study'sThe purpose is to evaluate pembrolizumab monotherapy for various advanced stages after prior standard treatment failure.(Non-resectable and/or metastatic)MSI-H/dMMR Solid Tumors in Mainland China SubjectsEfficacy and Safety. ResearchThe primary endpoint is ORR, and secondary endpoints include PFS, OS, and duration of response.（DOR）And its relationship with MSI-H, the safety and tolerability of pembrolizumab, exploratory endpoints are comparisons of ORR, DOR, and PFS based on irRECIST and RECIST 1.1, patient-reported outcomes（PRO）。MSD's clinical data released in 2022 showed,In 90 patients,ORR was 48%(95% CI, 37 to 60), Median DOR Not Reached（NR），MedianPFS was 13.1 months, Median OS Not Reached。76% of patients experienced≥ 1 Treatment-related adverse event(Grade 3-4, 12%)No fatal treatment-related events occurred; 28% of patients experienced immune-mediated adverse events or infusion reactions.(Grade 3-4, 7%; no fatal events).Screenshot source: Insight database
Study data show that for previously treated patients with MSI-H/dMMR endometrial carcinoma, pembrolizumab demonstrates strong and durable antitumor activity and encouraging survival outcomes, with manageable toxicity.Endometrial cancer is the most common gynecological cancer, with approximately 417,000 new cases reported globally each year. It is projected that the incidence will increase by nearly 40% between 2020 and 2040, with about 15%-20% of endometrial cancer patients already in advanced stages at the time of diagnosis.It is worth noting that,Innovent's sintilimab endometrial cancer indication has also been submitted for marketing approval, combined with fruquintinib capsules for advanced pMMR or non-MSI-H endometrial cancer.（CXSS2400038）Insight database predicts approval in 2024 Q4。Bolizumab exceeded $25 billion in sales in 2023. Its recent approval in China for the endometrial cancer indication is expected to drive continued sales growth.Cover Source:Company LogoDisclaimer:This article is for information sharing only and does not represent the position or viewpoint of Insight. It also does not recommend or introduce any treatment plans. If you have any needs, please consult and contact正规医疗机构.PR Article Coordination: WeChat insightxbSubmissionWeChat: insightxb; Email: insight@dxy.cn
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