Photomicrograph of adenocarcinoma of endometrium in a biopsy from a patient with abnormal bleeding. Credit: David A Litman / Shutterstock.com.

Hutchmed has secured breakthrough therapy designation from the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) for a combination of fruquintinib and sintilimab (a PD-1 antibody) to treat advanced endometrial cancer (EMC).

This therapy is intended for patients with advanced EMC who have pMMR tumours [which have intact DNA mismatch repair] and who have failed at least one line of platinum-based therapy.

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Fruquintinib is a selective and potent oral inhibitor of vascular endothelial growth factor receptor, while sintilimab is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Eli Lilly and Innovent Biologics. Sintilimab is sold as TYVYT (sintilimab injection) in China.

A clinical trial for potential registration of the combination therapy in Chinese patients with previously treated advanced EMC has now concluded enrolment.

Hutchmed has enrolled 142 patients in the open-label and multicentre trial, which will assess the efficacy and safety of the combination of fruquintinib and sintilimab.

The trial’s primary endpoint is an independent review committee-assessed objective response rate.

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Its secondary points are overall survival, progression-free survival, disease control rate and pharmacokinetic assessments.

Positive trial results could result in an NMPA submission for regulatory approval in the treatment setting in the first half of 2024.

Hutchmed is also involved in the development of fruquintinib in China to treat multiple solid tumours, along with anti-PD-1 monoclonal antibodies.

The company markets fruquintinib within the country in partnership with Eli Lilly. Takeda Pharmaceutical holds a licence to market the drug outside China.