Hutchison China MediTech (Chi‑Med) has started its Phase III FRUTIGA clinical trial of fruquintinib and paclitaxel (Taxol) combination in patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Fruquintinib is an oral, highly selective and potent formulation being developed to inhibit vascular endothelial growth factor receptors (VEGFR) 1, 2 and 3 throughout the day.
The randomised, double-blind, placebo-controlled, multi-centre Phase III trial is designed to assess the safety and efficacy of the combination therapy in more than 500 patients who have progressed following first-line standard chemotherapy, including platinum and fluorouracil.
During the trial, the combination will be compared with paclitaxel monotherapy as second-line treatment of advanced gastric or GEJ adenocarcinoma.
Chi-Med CEO Christian Hogg said: "Fruquintinib was designed to be a highly selective inhibitor of VEGFR 1, 2 and 3, which has shown the potential ability to combine with chemotherapy, a novel approach in the treatment of advanced gastric cancer.
"With fruquintinib’s new drug application (NDA) in third-line colorectal cancer (CRC) under review and its Phase III trial in third-line non-small cell lung cancer nearing full enrolment, we are excited to now also enter the final phase of development in second-line gastric cancer, a very large indication in which there is significant patient need for new treatment options in China."
The primary efficacy endpoint of the Phase III FRUTIGA trial is overall survival (OS), while the secondary efficacy endpoints include progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), duration of response and quality-of-life score.
FRUTIGA will further investigate biomarkers associated with the anti-tumour activity of fruquintinib.