Tyvyt and Elunate combo approved for endometrial cancer in China

This approval follows the priority review status and breakthrough therapy designation by the National Medical Products Administration (NMPA) of China and marks the eighth approved indication for Tyvyt (sintilimab injection).

The conditional approval by the NMPA was supported by registration stage data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase IIstudy investigating sintilimab in combination with fruquintinib in endometrial cancer patients who have experienced disease recurrence, disease progression or intolerable toxicity with treatment on platinum-based doublet chemotherapy. Results from FRUSICA-1 were presented at the American Society of Clinical Oncology annual meeting in June 2024^] The study results showed that IRC-assessed ORR and DCR was 35.6% and 88.5% respectively; the combination treatment showed rapid on-set efficacy, with a median time to tumor response (mTTR) of only 1.6 months. The median PFS and OS reached 9.5 months and 21.3 months, respectively. Adverse events are consistent with those reported for similar immunotherapy and antiangiogenic agents combination treatments. Additional details can be found at clinicaltrials.gov, using identifier NCT03903705. A Phase III confirmatory study of the sintilimab and fruquintinib combination in this setting has been planned (NCT06584032).

"This approval of sintilimab plus fruquintinib could represent a paradigm shift in managing this challenging disease. This innovative combination not only leverages the synergistic effects of targeted therapy and immunotherapy, but also addresses a critical gap in treatments available for patients with limited responses to traditional therapies," said Prof. Xiaohua Wu, Director of the Department of Gynecologic Oncology at Fudan University Affiliated Cancer Hospital and Principal Investigator of the FRUSICA-1 study. "With the promising efficacy and manageable safety profile observed in clinical trials, we are eager to have this treatment option available to patients. It brings us closer to our goal of improving survival and enhancing quality of life for patients living with advanced endometrial cancer."