FRESCO-2: a global Phase III study investigating the efficacy and safety of fruquintinib in metastatic colorectal cancer
Arvind Dasari, Alberto Sobrero, James Yao, Takayuki Yoshino, William Schelman, Zhao Yang, Caly Chien, Marek Kania, Josep Tabernero, Cathy Eng, Arvind Dasari, Alberto Sobrero, James Yao, Takayuki Yoshino, William Schelman, Zhao Yang, Caly Chien, Marek Kania, Josep Tabernero, Cathy Eng
Abstract
Fruquintinib, a novel, highly selective, small-molecule tyrosine kinase inhibitor of VEGF receptors (VEGFRs)-1, -2 and -3, is approved in China for the treatment of metastatic colorectal cancer. FRESCO-2, a global, randomized, double-blind, placebo-controlled, Phase III study, is investigating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. Key inclusion criteria include: progression on or intolerance to TAS-102 and/or regorafenib; and prior treatment with approved chemotherapy, anti-VEGF therapy, and, if RAS wild-type, anti-EGFR therapy. Approximately 687 patients will be randomized 2:1 to fruquintinib plus best supportive care or placebo plus best supportive care. Primary and key secondary end points are overall survival and progression-free survival, respectively. FRESCO-2 is enrolling in the USA, Europe, Australia and Japan.
Trial registration: ClinicalTrials.gov NCT04322539.
Keywords: FRESCO-2; HMPL-013; Phase III study; TKI; VEGF; VEGFR; clinical development; fruquintinib; mCRC; refractory metastatic colorectal cancer.
Source: PubMed