On June 4, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that the Independent Data Monitoring Committee (IDMC) of the FRUTIGA study of fruquintinib has completed a planned interim data review (Press release, Hutchison China MediTech, JUN 4, 2020, https://www.chi-med.com/chi-med-announces-the-continuation-of-phase-iii-frutiga-study/ [SID1234560818]). Based on the preset criteria, the IDMC recommended that the trial continue.
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FRUTIGA is a Phase III trial in China of fruquintinib in combination with paclitaxel (Taxol) in the treatment of patients with advanced gastric adenocarcinoma or gastroesophageal junction ("GEJ") adenocarcinoma who have progressed after first-line standard chemotherapy.
About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial factor receptor ("VEGFR") 1/2/3. 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 be highly suitable for combinations with other anti-cancer therapies.
About FRUTIGA in Gastric Cancer
FRUTIGA is a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or GEJ adenocarcinoma. The trial is designed to enroll patients who did not respond to first-line standard chemotherapy. Subjects will receive either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. Patients will be randomized at a 1:1 ratio and stratified according to factors such as stomach vs. GEJ tumor type and performance status. The primary efficacy endpoint is overall survival. Secondary efficacy endpoints include progression-free survival (as defined by RECIST 1.1), objective response rate, disease control rate, duration of response, and quality-of-life score (EORTC QLQ-C30, version 3.0). Biomarkers related to the antitumor activity of fruquintinib will also be explored.
Additional details about this study can be found at clinicaltrials.gov, using identifier NCT03223376.
FRUTIGA was initiated following the results of an open label, multi-center Phase Ib dose finding/expansion study of fruquintinib in combination with paclitaxel (Taxol) as a second-line treatment in patients with advanced gastric cancer (clinicaltrials.gov identifier NCT02415023).
Other Fruquintinib Development
Fruquintinib was approved for marketing in China by the NMPA in September 2018 and commercially launched by Eli Lilly and Company ("Lilly") in late November 2018 under the brand name Elunate. Elunate is for the treatment of patients with metastatic colorectal cancer that have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with colorectal cancer ("CRC") in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).
Chi-Med retains all rights to fruquintinib outside of China and is partnered with Lilly in China.
Global development of fruquintinib in CRC: We are initiating a Phase III registration study, known as the FRESCO-2 study, in the U.S., Europe and Japan in CRC. FRESCO-2 is expected to start enrolling patients in mid-2020. Based on our agreement with the U.S. Food and Drug Administration (FDA), the FRESCO and FRESCO-2 studies, if positive, could support our New Drug Application (NDA).
Immunotherapy combinations: We have entered into three collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with programmed death-1 (PD-1) monoclonal antibodies, including with tislelizumab (BGB-A317), Tyvyt (sintilimab, IBI308) and geptanolimab (GB226, genolimzumab).