HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Endometrial Cancer with Priority Review Status

Regulatory and Clinical Developments - The New Drug Application (NDA) for the combination of fruquintinib and sintilimab for advanced endometrial cancer has been accepted and granted priority review by the China National Medical Products Administration (NMPA) [1] - This is the first regulatory filing for fruquintinib in combination with an immune checkpoint inhibitor [3] - The NMPA granted Breakthrough Therapy designation to the combination in July 2023, recognizing its potential to address a serious condition with no effective treatment options [3] - The NDA is supported by data from the FRUSICA-1 study, a Phase II trial investigating the combination in endometrial cancer patients who failed prior systemic therapy [2] Endometrial Cancer Overview - Endometrial cancer is a common gynecological malignancy, with an estimated 417,000 global cases and 97,000 deaths in 2020 [4] - In China, approximately 82,000 people were diagnosed with endometrial cancer, resulting in 17,000 deaths in 2020 [4] - Recurrent and metastatic endometrial cancer remains an area of high unmet need with limited treatment options [4] Fruquintinib Profile - Fruquintinib is a selective oral inhibitor of VEGFR-1, -2, and -3, designed to inhibit tumor angiogenesis with enhanced selectivity and manageable safety [5] - It is approved in China for metastatic colorectal cancer and included in the National Reimbursement Drug List (NRDL) since January 2020 [6][7] - In the US, fruquintinib (marketed as FRUZAQLA™) received approval in November 2023 for metastatic colorectal cancer, supported by Phase III trials FRESCO and FRESCO-2 [8] Sintilimab Profile - Sintilimab, marketed as TYVYT® in China, is a PD-1 monoclonal antibody co-developed by Innovent and Eli Lilly [9] - It is approved in China for seven indications, including non-small cell lung cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma [9] - The combination of sintilimab and fruquintinib for advanced endometrial cancer has been granted priority review by the NMPA [10] Company Overview - HUTCHMED is a biopharmaceutical company focused on developing targeted therapies and immunotherapies for cancer and immunological diseases, with approximately 5,000 employees globally [11] - Innovent is a leading biopharmaceutical company with a mission to provide affordable biologics, having launched 10 products and with multiple assets in clinical development [12] Clinical Trial Data - The FRUSICA-1 study evaluated fruquintinib in combination with sintilimab in endometrial cancer patients, with primary and secondary endpoints including ORR, DCR, DoR, PFS, and OS [2] - Data from FRUSICA-1 will be presented at an upcoming medical conference [2]