Innovent, Hutchmed announce conditional approval for cancer drug combination therapy

Innovent Biologics and Hutchmed (china) limited have received conditional nmpa approval for the combination therapy of tyvyt (sintilimab injection) and elunate (fruquintinib) for treating advanced endometrial cancer with mismatch repair-proficient tumors.

The conditional NMPA approval addresses a significant need for patients whose tumors resist traditional systemic therapy and are unsuitable for surgery or radiation. The combination therapy approval follows priority review and breakthrough therapy designation by the National Medical Products Administration (NMPA) in China. This milestone marks the eighth approved indication for TYVYT (sintilimab), highlighting its growing importance in cancer treatment advancements.

Key findings and clinical trial data

The conditional NMPA approval is based on promising results from the FRUSICA-1 cohort, a phase 2 trial investigating the therapy’s efficacy. The study demonstrated an overall response rate (ORR) of 35.6% and a disease control rate (DCR) of 88.5%. The median progression-free survival (PFS) and overall survival (OS) reached 9.5 months and 21.3 months, respectively.

The rapid onset of efficacy, seen within 1.6 months, emphasizes the potential of this novel treatment option for improving outcomes in patients with advanced endometrial cancer. Additionally, the safety profile aligns with established data for similar targeted and immunotherapy combinations, making it a viable candidate for wider adoption. Hutchmed has also planned a Phase 3 trial to further validate the findings.

Expert opinions highlight innovation

Experts highlight the innovation behind this combination therapy approval, emphasizing its ability to address unmet medical needs. According to Professor Xiaohua Wu, the principal investigator in the FRUSICA-1 trial, this novel treatment option leverages the synergy of targeted and immunotherapy, creating a new approach to managing advanced endometrial cancer.

Dr. Hui Zhou of Innovent described the approval as a major step in cancer treatment advancements, reinforcing their commitment to enhancing survival rates and quality of life for patients. Similarly, Dr. Michael Shi of Hutchmed stated that the success of fruquintinib in combination therapy underlines its potential to improve patient outcomes further.

Targeted therapies: A growing market

TYVYT (sintilimab) is co-developed by Innovent Biologics and Eli Lilly and Company. Known for its role in cancer treatment advancements, sintilimab has been pivotal in immune checkpoint inhibition therapies. Fruquintinib, developed by Hutchmed, is an oral VEGF receptor inhibitor designed to work seamlessly in targeted and immunotherapy settings, which is crucial for enhancing the efficacy of combination therapy approval initiatives.

The approval highlights the growing trend of using targeted therapies alongside immunotherapies to achieve better outcomes for advanced endometrial cancer patients, a population with limited treatment options.

Addressing endometrial cancer challenges

Globally, advanced endometrial cancer remains a critical challenge. With approximately 417,000 new cases reported annually, including 82,000 in China, the disease poses significant healthcare concerns. While early-stage cases can often be managed with surgery, recurrent and metastatic cases present limited options.

The conditional NMPA approval of this innovative treatment is a step forward, offering a lifeline for patients previously underserved by traditional therapies. By improving progression-free and overall survival, this novel treatment option contributes to ongoing cancer treatment advancements and sets a precedent for future approvals in similar areas of high unmet medical need.