HUTCHMED Publishes Phase III FRUTIGA Results in Nature Medicine, Presents Updated Data at ASCO 2024

June 03, 2024 -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) has announced the publication of results from its Phase III FRUTIGA trial in Nature Medicine. This trial evaluated the efficacy of fruquintinib combined with paclitaxel for treating second-line advanced gastric cancer in China. The results, including key subgroup data and quality of life (QoL) outcomes, were also highlighted at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting.

Fruquintinib is an oral inhibitor targeting VEGFRs 1, 2, and 3, crucial for cancer growth due to their role in angiogenesis. Gastric cancer, the fifth most prevalent malignant cancer globally, presents a significant clinical challenge. FRUTIGA's findings suggest fruquintinib as a promising treatment option for these patients.

The FRUTIGA trial was a double-blind, randomized Phase III study involving 703 patients with advanced gastric or gastroesophageal junction adenocarcinoma across 35 sites in China. It compared fruquintinib plus paclitaxel against paclitaxel alone. The study met its primary endpoint by demonstrating a statistically significant improvement in progression-free survival (PFS). Patients receiving the combination therapy had a median PFS of 5.6 months, compared to 2.7 months for those on paclitaxel alone (stratified hazard ratio [HR] = 0.569; p < 0.0001). The combination also showed a median overall survival (OS) of 9.6 months versus 8.4 months for paclitaxel monotherapy, though this was not statistically significant. Additionally, the combination therapy improved other endpoints like objective response rate (ORR), disease control rate (DCR), and duration of response (DoR), and was well-tolerated with a safety profile consistent with previous studies.

Further subgroup analysis presented at ASCO revealed consistent PFS and OS benefits across most subgroups, particularly in intestinal-type and lymph node metastasis subgroups. Patients with lymph node metastasis showed superior benefits in PFS, OS, ORR, DCR, and DoR when treated with fruquintinib. This effect is likely due to fruquintinib’s strong inhibition of VEGFR-3, which is associated with lymph node metastasis and tumor invasion. Additionally, patient-reported QoL analysis indicated no negative impact compared to standard care, supporting the combination's viability as a treatment option.

Key results from FRUTIGA were earlier shared at the ASCO Plenary Series Session in February 2024. Fruquintinib is already approved in China and the U.S. for metastatic colorectal cancer (CRC) treatment. The China National Medical Products Administration (NMPA) is reviewing a New Drug Application (NDA) for using fruquintinib with paclitaxel for second-line advanced gastric or gastroesophageal junction adenocarcinoma.

Gastric cancer begins in the stomach and is the fifth most common cancer worldwide. It caused an estimated 770,000 deaths globally in 2020. In China, around 478,000 new cases and 374,000 deaths were reported in the same year.

Fruquintinib, an oral inhibitor targeting VEGFR-1, -2, and -3, is developed for its high selectivity to limit off-target effects, ensuring significant drug exposure and sustained inhibition of its targets, making it suitable for combination therapies. Fruquintinib is marketed as ELUNATE® in China by HUTCHMED and Eli Lilly and Company and is included in the China National Reimbursement Drug List (NRDL). Since its launch, over 80,000 colorectal cancer patients have been treated with it.

In the U.S., Takeda holds exclusive rights to develop and commercialize fruquintinib, which is marketed as FRUZAQLA®. The U.S. approval was based on data from the FRESCO and multi-regional FRESCO-2 trials, which showed consistent benefits in 734 patients. The safety profile of fruquintinib was consistent across these trials.

HUTCHMED is a biopharmaceutical company dedicated to developing and commercializing targeted therapies and immunotherapies for cancer and immunological diseases, with a workforce of around 5,000, including 1,800 in oncology/immunology. The company focuses on advancing cancer treatments from discovery to global patient access, with several medicines already available in China and the U.S.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!