HUTCHMED and Innovent Biologics have announced that the China National Medical Products Administration (NMPA) has conditionally approved the combination therapy of fruquintinib and sintilimab for treating advanced endometrial cancer. This approval covers patients with proficient mismatch repair (pMMR) tumors who have not responded to prior systemic therapies and are not eligible for curative surgery or radiation.
The approval follows a priority review process and breakthrough therapy designation granted by the NMPA, marking the first regulatory clearance for using fruquintinib alongside an immune checkpoint inhibitor.
Clinical Trial Data Supporting Approval
The NMPA's decision was based on findings from the FRUSICA-1 trial, a Phase II study that evaluated the combination in patients with recurrent or progressive endometrial cancer who had previously undergone platinum-based chemotherapy.
Results presented at the 2024 American Society of Clinical Oncology (ASCO) meeting showed an objective response rate (ORR) of 35.6% and a disease control rate (DCR) of 88.5%. The median time to response (TTR) was 1.6 months, while median progression-free survival (PFS) and overall survival (OS) were 9.5 months and 21.3 months, respectively.
The adverse events observed were consistent with those typically seen in treatments combining immunotherapy and anti-angiogenic agents.
A Phase III confirmatory trial for this combination is planned under the identifier NCT06584032.
Endometrial Cancer Overview
Endometrial cancer begins in the lining of the uterus and poses a significant health challenge worldwide. In 2020, around 417,000 new cases were reported globally, resulting in approximately 97,000 deaths. In China, the same year saw an estimated 82,000 new cases and 17,000 deaths. While early-stage cases can often be treated with surgery, advanced or metastatic endometrial cancer has limited treatment options and poor prognosis.
About Fruquintinib
Fruquintinib is an oral medication designed to selectively inhibit vascular endothelial growth factor receptors (VEGFR-1, -2, and -3). These receptors play a key role in the growth of blood vessels that feed tumors. Fruquintinib’s targeted design reduces off-target effects, allowing for sustained inhibition and compatibility with combination therapies.
Fruquintinib is approved in China for treating metastatic colorectal cancer in patients who have previously undergone fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy. It is jointly developed and marketed in China by HUTCHMED and Eli Lilly. Since its inclusion in the National Reimbursement Drug List (NRDL) in 2020, over 100,000 colorectal cancer patients have been treated with fruquintinib.
Outside China, Takeda holds exclusive rights to develop and market fruquintinib. The drug is approved in several regions, including the United States, the European Union, Switzerland, Canada, Japan, the United Kingdom, Argentina, Australia, and Singapore, with further regulatory applications underway.
About Sintilimab
Sintilimab is a PD-1 monoclonal antibody developed by Innovent and Eli Lilly. It works by blocking the PD-1 pathway, reactivating T-cells to target and destroy cancer cells. Sintilimab is approved in China for multiple indications, including various types of lung cancer, Hodgkin’s lymphoma, liver cancer, and esophageal cancer. It is included in the NRDL for these uses.
The latest conditional approval covers the use of sintilimab in combination with fruquintinib for advanced endometrial cancer patients with pMMR tumors who have not responded to prior therapies. This marks the therapy's eighth approved indication in China.
Additionally, two clinical trials for sintilimab have successfully met their primary endpoints, evaluating its efficacy as a second-line treatment for esophageal squamous cell carcinoma and squamous non-small cell lung cancer.
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