HUTCHMED's Fruquintinib Combo Receives Breakthrough Designation in China for Advanced Endometrial Cancer, Enrollment Complete

20 July 2023 | Thursday | News

HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to the combination of fruquintinib and sintilimab (a PD-1 antibody) for the treatment of patients with advanced endometrial cancer (“EMC”) with pMMR1 tumors that have failed at least one line of platinum-based therapy. A study for potential registration of this combination in patients with previously treated advanced EMC in China has recently completed enrollment.
Image Source | Public Domain

Image Source | Public Domain

It is a multi-center, open-label clinical study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab. Entry criteria include those EMC patients who experienced disease recurrence, disease progression or grade 3 or higher serious adverse events with treatment on platinum-based chemotherapy. The primary endpoint is independent review committee (IRC) assessed objective response rate (“ORR”), with secondary endpoints including disease control rate (“DCR”), progression free survival (“PFS”), overall survival (“OS”), as well as pharmacokinetic (PK) assessments. A total of 142 previously treated, advanced EMC patients were enrolled. Additional details may be found at, using identifier NCT03903705.

Favorable results from this trial could lead to submission to the NMPA in the first half of 2024 for regulatory approval in this treatment setting.

Breakthrough Therapy Designation in China

NMPA grants BTD to new drugs that treat life-threatening diseases or serious conditions for which there are no effective treatment options, and where clinical evidence demonstrates significant advantages over existing therapies. Drug candidates with BTD may be considered for conditional approval and priority review when submitting a New Drug Application (“NDA”). This indicates that the development and review of the therapy for this disease indication may be expedited, to address patients’ unmet needs more quickly.


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