Hutchison China MediTech (AIM, NASDAQ:HCM) has initiated a U.S. Phase 1 bridging clinical trial of fruquintinib, a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors 1, 2 and 3, that has met its primary endpoint in several Phase 2 and 3 clinical trials in China for the treatment of colorectal, lung and gastric cancers.
Chi-Med’s clinical study in the U.S. is a multi-center, open-label study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors. The first drug dose was administered earlier this month.
In China, where fruquintinib is jointly developed with Eli Lilly, the China Food and Drug Administration in June 2017 accepted a NDA for fruquintinib for the treatment of patients with advanced colorectal cancer (CRC). Fruquintinib also has received priority review status.
The NDA is supported by data from the successful FRESCO study, a Phase 3 pivotal registration trial of fruquintinib in 416 patients with CRC in China, which was highlighted in an oral presentation at the American Society of Clinical Oncology annual meeting on June 5, 2017.
In lung cancer, fruquintinib is being studied in a Phase 3 pivotal trial in approximately 520 third-line non-small cell lung cancer (NSCLC) patients, known as the FALUCA study. Fruquintinib is concurrently being studied in a Phase 2 study in combination with Iressa in a first-line setting for patients with advanced or metastatic NSCLC.
In October 2017, Chi-Med initiated the FRUTIGA Phase 3 clinical trial with fruquintinib, in combination with Taxol, in more than 500 patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.