HUTCHMED (China) Limited has announced initial results from FRUTIGA, a phase III study of fruquintinib combined with paclitaxel in 703 Chinese patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The trial was positive, having met one of the primary endpoints of statistically significant improvement in progression-free survival (PFS), which is clinically meaningful. The other primary endpoint of overall survival (OS) was not statistically significant per the pre-specified statistical plan, although there was an improvement in median OS.
Fruquintinib also demonstrated a statistically significant improvement in secondary endpoints including objective response rate (ORR), disease control rate (DCR), and improved duration of response (DoR). The safety profile of fruquintinib in FRUTIGA was consistent with previously reported studies.
Full detailed results are subject to ongoing analysis and are expected to be disclosed at an upcoming scientific meeting. The results as well as further analyses will be shared with the China National Medical Products Administration (NMPA).
NDA filing
“The combination of fruquintinib and paclitaxel demonstrated significant clinical benefits for these patients in controlling this disease. Our team will continue to analyze the data and discuss these findings with the NMPA for possible NDA filing,” said Weiguo Su, chief executive officer and chief scientific officer of HUTCHMED.
Rui-Hua Xu, president of the Sun Yat-Sen University Cancer Center, who served as the FRUTIGA lead principal investigator and steering committee chairman, said: “By meeting the primary endpoint of PFS, fruquintinib demonstrated consistent efficacy and safety in gastric cancer indication in addition to its approved colorectal cancer indication. I am extremely excited that fruquintinib may provide a potential new oral treatment option for second line gastric cancer patients based on the FRUTIGA trial.”
HUTCHMED retains all commercial rights to fruquintinib outside of China. In China, where fruquintinib is marketed under the brand name ELUNATE, HUTCHMED is partnered with Eli Lilly and Company. HUTCHMED is responsible for development and execution of all on-the-ground medical detailing, promotion and local and regional marketing. Fruquintinib is not approved for use outside of China.
Gastric cancer is the fourth leading cause of cancer death worldwide. More than one million new cases of gastric cancer and approximately 769,000 deaths were estimated in 2020 worldwide, with the highest incidence rates in several Eastern Asian countries. In 2020, there were 478,500 new gastric cancer cases and 331,600 deaths estimated in China. Due to late-onset symptoms, gastric cancer is often diagnosed at an advanced stage with poor prognosis and limited treatment options.
About HUTCHMED’s Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage.
The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.