Chi-Med Initiates FRESCO-2, a Global Phase III Trial of Fruquintinib in Metastatic Colorectal Cancer - Seite 2

Chi-Med retains all rights to fruquintinib outside of China and is partnered with Eli Lilly and Company (“Lilly”) in China.

About Fruquintinib in metastatic CRC

Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched by Lilly in late November 2018 under the brand name Elunate. Elunate is for the treatment of patients with metastatic CRC 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 metastatic CRC in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).

In December 2017, Chi-Med initiated a multi-center, open-label, Phase I/Ib clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors (clinicaltrials.gov identifier: NCT03251378). Proof-of-concept cohorts in patients with metastatic CRC and metastatic breast cancer were added in 2019. 

Other Fruquintinib Development

Gastric Cancer in China: In October 2017, Chi-Med initiated the FRUTIGA study, 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 esophagogastric junction (“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 (clinicaltrials.gov identifier NCT03223376).  In June 2020, Chi-Med completed a planned interim data review.  Based on the preset criteria, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue.