Hutchmed (china) (00013) and Innovent Bio (01801) jointly announced that Elunate (fruquintinib) and Tyvyt (sintilimab injection) combination therapy has been conditionally approved for marketing in China for the new drug application to treat advanced mismatch repair deficient complete (pMMR) endometrial cancer patients who have failed previous systemic anticancer therapy and are not suitable for radical surgical or radiotherapy procedures. This combination therapy had been priorized for review by the China National Medical Products Administration and considered a breakthrough therapy. This approval signifies the first regulatory registration approval of the fruquintinib and leading immune checkpoint inhibitor combination therapy.

The conditional approval by the National Medical Products Administration was based on data from the FRUSICA-1 study registration stage. FRUSICA-1 is a multicenter, open-label Phase II clinical trial registration cohort for endometrial cancer, evaluating the use of fruquintinib in combination with sintilimab in patients with relapsed, progressive, or intolerable toxicity after platinum-based doublet chemotherapy. Data from the FRUSICA-1 study was presented at the 2024 American Society of Clinical Oncology (ASCO) annual meeting in June 2024, showing an objective response rate (ORR) of 35.6%, disease control rate (DCR) of 88.5%. The combination therapy has shown rapid efficacy with a median time to response of 1.6 months, a median progression-free survival (PFS) of 9.5 months, and a median overall survival (OS) of 21.3 months. Adverse events were consistent with reported immunotherapy combination anti-angiogenic therapy. More details of this study can be found on clinicaltrials.gov, by searching the registration number NCT03903705.

Professor Wu Xiaohua, Director of the Department of Gynecologic Oncology at Fudan University Affiliated Cancer Hospital and lead researcher of the FRUSICA-1 study, stated: "The approval of the combination therapy of fruquintinib with sintilimab for this challenging disease opens a new chapter in its treatment. This innovative combination therapy not only leverages the synergistic effects of targeted and immune therapies but also fills a key gap in the treatment of patients with poor response to traditional therapies. The encouraging efficacy and manageable safety demonstrated in clinical trials of this combination therapy give us hope to provide this treatment option to patients and further improve the survival rate and quality of life of advanced endometrial cancer patients."

Dr. Shi Ming, Chief Medical Officer and Head of Research and Development at Hutchmed (china), stated: "The approval of the fruquintinib and sintilimab combination therapy by the National Medical Products Administration is a significant step forward for advanced endometrial cancer patients who have long awaited more effective treatments. This not only highlights the potential of fruquintinib in combination with other drugs to improve patient outcomes but also reflects our ongoing efforts to extend the clinical benefits of fruquintinib to a broader patient population. We look forward to bringing this innovative therapy to advanced endometrial cancer patients as soon as possible and will continue to explore more possibilities to bring hope to more cancer patients."

Dr. Zhou Hui, Senior Vice President of Innovent Bio, stated: "The approval of the combination therapy of sintilimab and fruquintinib marks an important advancement in the treatment of advanced endometrial cancer. We are committed with Hutchmed (china) to provide new treatment options and improve survival rates and quality of life for these patients with very limited treatment choices. Tyvyt (sintilimab injection) as a cornerstone of immunotherapy continues to explore combinations with other innovative therapies in clinical trials. We are steadfast in consolidating Tyvyt's (sintilimab injection) leadership in the field of immunotherapy and advancing treatment solutions through innovation and collaboration."

In July 2023, the combination therapy of fruquintinib and sintilimab was included in the breakthrough therapy category by the National Medical Products Administration for this potential indication. Being included in the breakthrough therapy category recognizes the therapeutic potential of this treatment for severe diseases with no effective treatment options, as well as significant clinical advantages over existing treatments supported by clinical evidence.