Global Phase III FRESCO-2 Study Has Met Its Primary Endpoint in Evaluation of Fruquintinib for Metastatic Colorectal Cancer

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The pivotal global phase III FRESCO-2 trial evaluating the investigational use of fruquintinib met its primary endpoint of overall survival in patients with advanced, refractory metastatic colorectal cancer. The U.S. Food and Drug Administration (FDA) granted Fast Track designation for the development of fruquintinib in this setting in June 2020.

The FRESCO-2 study ( identifier NCT04322539) was a multiregional clinical trial conducted in the United States, Europe, Japan, and Australia that investigated fruquintinib plus best supportive care vs placebo plus best supportive care in patients with metastatic colorectal cancer whose disease had progressed on standard chemotherapy and relevant biologic agents and who had disease progression on or were intolerant to TAS-102 and/or regorafenib. In addition to overall survival, a statistically significant improvement in progression-free survival, a key secondary endpoint, was observed.

The safety profile of fruquintinib in FRESCO-2 was consistent with previously reported studies. Full results will be submitted for presentation at an upcoming medical meeting.

Praise for FRESCO-2

“We are very happy to see the positive outcomes of the FRESCO-2 study, which offers a potential new treatment for patients with advanced metastatic colorectal cancer, where the unmet need is very high and patients have limited treatment options,” said Marek Kania, MD, MBA, Executive Vice President, Managing Director and Chief Medical Officer of Hutchmed International, the manufacturer of fruquintinib. “Results from the global FRESCO-2 study supplement findings from the original FRESCO study that led to the marketing approval and commercialization of fruquintinib in China.”

Cathy Eng, MD, FACP, FASCO, the David H. Johnson Endowed Chair in Surgical and Medical Oncology and Co-Leader, Gastrointestinal Cancer Research Program, at the Vanderbilt-Ingram Cancer Center, who served as the FRESCO-2 co–principal investigator and Steering Committee member said: “Completion of the international FRESCO-2 phase III trial in a timely fashion during the era of COVID-19 isolation demonstrates the unmet need for new therapeutic agents in metastatic colorectal cancer. By meeting the primary endpoint of overall survival with a secondary endpoint of progression-free survival, fruquintinib provides a significant potential new option for our patients with refractory colorectal cancer. As an oral agent, fruquintinib also provides added convenience for our patients. Based on fruquintinib’s profile, we will likely see further exploration in future clinical trials in different settings. This is extremely encouraging, and I look forward to seeing the final results.”

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2, and VEGFR-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 also be highly suitable for combinations with other anticancer therapies.

Fruquitinib has been approved for marketing in China in metastatic colorectal cancer and is being investigated in gastric cancer, as well as in immunotherapy combinations for breast, endometrial, colorectal, non–small cell lung, and other solid tumors.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.