HUTCHMED (China) Limited, a leading biopharmaceutical company, has achieved a significant milestone in cancer treatment. The Center for Drug Evaluation of China's National Medical Products Administration (NMPA) has recently granted Breakthrough Therapy Designation (BTD) to the combination of fruquintinib and sintilimab for the treatment of patients with advanced endometrial cancer (EMC) with pMMR1 tumors. This designation comes after a successful multi-center clinical study that explored the efficacy and safety of this innovative combination therapy.

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Breakthrough Therapy Designation for Advanced Endometrial Cancer

The Breakthrough Therapy Designation by the NMPA represents a major recognition of the potential impact of fruquintinib and sintilimab in treating patients with advanced EMC who have previously failed at least one line of platinum-based therapy. This designation signifies that the combination therapy has shown promising early clinical results and offers a new ray of hope for patients facing this challenging condition.

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Study Details and Enrollment

The clinical study conducted by HUTCHMED was an open-label, multi-center trial aimed at evaluating the efficacy and safety of fruquintinib in combination with sintilimab. The study enrolled 142 previously treated patients with advanced EMC who met specific entry criteria. These criteria included patients who had experienced disease recurrence, disease progression, or grade 3 or higher serious adverse events despite undergoing platinum-based chemotherapy.

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Study Endpoints

The primary endpoint of the study was the objective response rate (ORR) as assessed by an independent review committee (IRC). Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), as well as pharmacokinetic (PK) assessments. These endpoints served as critical indicators of the therapy's effectiveness and safety.

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Promising Future Prospects

With the completion of enrollment in the clinical trial and the encouraging results obtained so far, HUTCHMED is now looking ahead to potential regulatory approval in China. Favorable outcomes from this trial could lead to a submission to the NMPA in the first half of 2024. If approved, fruquintinib and sintilimab combination therapy would offer a much-needed treatment option for patients with previously treated advanced EMC, potentially improving their quality of life and extending survival.