Hutchmed has reported positive data from the Phase III FRUTIGA study of fruquintinib to treat advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma.
The double-blind, randomised Phase III study was designed for assessing fruquintinib along with paclitaxel, compared with paclitaxel alone, as a second-line treatment of gastric cancer.
In the trial, 703 Chinese patients who did not respond to first-line standard chemotherapy were enrolled.
Findings from the study showed that fruquintinib met one of the two primary endpoints of statistically significant and clinically meaningful improvement in progression-free survival (PFS).
Overall survival, the other primary endpoint, was not statistically significant as per the pre-specified statistical plan.
The company stated that fruquintinib also showed a statistically significant improvement in secondary endpoints, which includes disease control rate (DCR), as well as objective response rate (ORR).
It has also improved the response duration.
Fruquintinib’s safety profile in the study was consistent with the previously reported trials.
Hutchmed CEO and chief scientific officer Dr Weiguo Su said: “The combination of fruquintinib and paclitaxel demonstrated significant clinical benefits for these patients in controlling this disease.
“Our team will continue to analyse the data and discuss these findings with the NMPA for possible NDA filing.”
The company stated that the complete detailed results from the Phase III study are subject to ongoing analysis.
It will share the Phase III study data, along with further analyses, with the China National Medical Products Administration (NMPA).
Hutchmed has collaborated with Eli Lilly and Company to market fruquintinib in China while the company will retain all its commercial rights outside China.
The company will also develop and execute all on-the-ground medical detailing, promotion, and local and regional marketing.