HUTCHMED (China) Limited and Innovent Biologics, Inc. jointly announce that the New Drug Application for the combination of fruquintinib and sintilimab for the treatment of patients with advanced endometrial cancer with pMMR1 or non-MSI-H2 tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation has been accepted and granted priority review by the China National Medical Products Administration. The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase II study investigating fruquintinib in combination with sintilimab in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity with treatment on platinum-based doublet chemotherapy. The primary endpoint was independent review committee (IRC) assessed objective response rate (ORR), with secondary endpoints including disease control rate (DCR), duration of response (DoR), progression free survival (PFS), overall survival (OS), as well as pharmacokinetic (PK) assessments.

Data from FRUSICA-1 will be submitted for presentation at an upcoming medical conference. Additional details may be found at clinicaltrials.gov, using identifier NCT03903705. The NMPA granted Breakthrough Therapy designation to the combination of fruquintinib and sintilimab for this potential indication in July 2023.

The NMPA granted this designation to this combination as a new treatment that could target a serious condition for which there are no effective treatment options, and where clinical evidence demonstrates substantial advantages over existing therapies.