Phase III FRUTIGA study of HMPL 013 + Taxol meets one primary endpoint in gastric cancer
HUTCHMED announced initial results from FRUTIGA, a Phase III study of HMPL 013 + Taxol (fruquintinib + paclitaxel) in 703 Chinese patients with advanced gastric or gastroesophageal junction adenocarcinoma
The trial was positive, having met one of the primary endpoints of statistically significant improvement in progression-free survival, which is clinically meaningful. The other primary endpoint of overall survival 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, disease control rate, and improved duration of response. 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. These results as well as further analyses will be shared with the China National Medical Products Administration.
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