HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) has announced that the combination of Elunate (fruquintinib) and Tyvyt (sintilimab) has been granted Breakthrough Therapy Designation (BTD) in China for the treatment of patients with mismatch repair normal (pMMR) advanced endometrial cancer. These patients have previously failed at least one line of platinum-containing treatment. A study supporting the potential New Drug Application (NDA) filing has recently completed patient enrollment.
Multi-Center Clinical Study Details
The multi-center, open-label clinical study is designed to evaluate the efficacy and safety of the fruquintinib-sintilimab combination. The study includes entry criteria for endometrial cancer (EMC) patients who have experienced disease recurrence, progression, or grade 3 or higher serious adverse events with treatment on platinum-based chemotherapy.
Elunate (Fruquintinib) Profile
Elunate is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor (VEGFR) 1, 2, and 3. It was approved for marketing by the National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in November of the same year for the treatment of metastatic colorectal cancer (mCRC) in patients who have been previously treated with fluoropyrimidine, oxaliplatin, and irinotecan. The drug was included in the National Reimbursement Drug List (NRDL) in January 2020. In March 2023, Takeda Pharma signed a USD 1.13 billion licensing deal for global development, manufacturing, and commercialization rights, excluding mainland China, Hong Kong, and Macau. Eli Lilly holds exclusive commercialization rights to the drug in China. A rolling submission of NDA to the U.S. Food and Drug Administration (FDA) was accepted and granted priority review in May 2023, with a Prescription Drug User Fee Act (PDUFA) date set for November 30, 2023. Submission to the European Medicines Agency (EMA) was validated in June 2023, with a submission to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) expected to be completed in 2023.
Tyvyt (Sintilimab) Profile
Sintilimab, an innovative PD-1 inhibitor developed by Innovent Biologics (HKG: 1801), has been approved for seven indications in China and included in the National Reimbursement Drug List (NRDL) for six indications. The drug is the subject of over 20 clinical studies, with a dozen being regulatory trials.-Fineline Info & Tech
