HONG KONG - HUTCHMED (China) Limited (NASDAQ/AIM:HCM; HKEX:13) and Innovent Biologics, Inc. (HKEX:1801) announced the conditional approval by China's National Medical (TASE:PMCN) Products Administration (NMPA) for ELUNATE® (fruquintinib) in combination with TYVYT® (sintilimab injection), marking the first regulatory nod for this drug pairing as a treatment for advanced endometrial cancer. The approval, announced today, is specifically for patients with Mismatch Repair proficient (pMMR) tumors who have not responded to previous systemic therapy and are ineligible for curative surgery or radiation.
The decision by the NMPA was supported by data from the FRUSICA-1 study, which demonstrated notable efficacy and manageable safety of the combination therapy. The study, involving patients who had disease recurrence or progression after platinum-based chemotherapy, showed an objective response rate of 35.6% and a disease control rate of 88.5%. The median progression-free survival and overall survival were reported as 9.5 months and 21.3 months, respectively.
Prof. Xiaohua Wu, the Principal Investigator of the FRUSICA-1 study, emphasized the treatment's potential to change the approach to managing advanced endometrial cancer, noting its synergistic effects and its role in addressing the lack of effective treatments for this patient population.
Dr. Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED, highlighted the significance of this approval for patients with advanced endometrial cancer, pointing out the company's commitment to extending the clinical benefit of fruquintinib to a broader patient base. Innovent's Senior Vice President, Dr. Hui Zhou, also underscored the importance of the combination therapy in improving survival rates and quality of life for patients with limited treatment options.
Endometrial cancer represents a serious global health issue, with approximately 417,000 diagnoses and around 97,000 deaths in 2020. The combination therapy's approval offers a new option for patients in China, where an estimated 82,000 new cases were reported that year.
Fruquintinib, a selective inhibitor of vascular endothelial growth factor receptors, has been approved for other indications, including metastatic colorectal cancer, and is marketed under different brand names globally. Sintilimab, a PD-1 monoclonal antibody, has been approved in China for multiple indications and is being evaluated in ongoing clinical trials.
A Phase III confirmatory study of the fruquintinib and sintilimab combination has been planned to further validate the findings. This news is based on a press release statement.
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