Oral Fruquintinib Provides ‘Potential New Option’ With ‘Added Convenience’ for Patients With Relapsed/Refractory Colorectal Cancer

Fruquintinib plus best supportive care improved overall survival (time from treatment until death of any cause) in patients with advanced, refractory metastatic colorectal cancer, according to findings from the phase 3 FRESCO-2 clinical trial.

“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 Dr. Marek Kania, executive vice president, managing director and chief medical officer of HUTCHMED International, the manufacturer of the VEGFR inhibitor, in a press release.

The main goal of the trial — which was conducted in cancer centers around the world — was to see if the novel agent fruquintinib plus best supportive care could improve overall survival outcomes in patients with colorectal cancer who had progressed on standard chemotherapy and relevant biologic agents, and progressed or were intolerant to TAS-102 and/or Stivarga (regorafenib).

Researchers also wanted to determine if fruquintinib could improve progression-free survival, which is the time from treatment until the disease progresses or gets worse. The goal was met as well.

“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 refractory colorectal cancer patients,” said Dr. Cathy Eng, co-primary investigator on FRESCO-2 and David H. Johnson Endowed Chair in Surgical and Medical Oncology and Co-Leader, Gastrointestinal Cancer Research Program, at the Vanderbilt-Ingram Cancer Center, in the release.

Fruquintinib was approved in China in 2018, and was granted a fast track designation by the Food and Drug Administration in June 2020, which will speed up the agency’s review and potential approval of the drug.

Based on the promising findings of FRESCO-2, Eng predicts that future trials will investigate fruquintinib in other settings as well.

“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,” Eng concluded. “This is extremely encouraging, and I look forward to seeing the final results.”

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