Efficacy of fruquintinib confirmed in refractory metastatic colorectal cancer

In patients with refractory metastatic colorectal cancer, fruquintinib treatment has resulted in a significant improvement in overall survival compared with placebo.

Researchers reported this finding on June 15, 2023 in The Lancet and simultaneously at the American Society of Clinical Oncology (ASCO) annual meeting.

“Patients with refractory metastatic colorectal cancer have very limited treatment possibilities and poor outcomes,” said principal investigator Arvind Dasari, M.D., associate professor of Gastrointestinal Medical Oncology at the University of Texas M.D. Anderson in Houston. “These results are very encouraging and confirm that fruquintinib may be a novel treatment opportunity for patients who previously had no other options….This study supports the meaningful survival improvement and manageable safety profile of fruquintinib,” Dasari added.” I am excited that this treatment could extend the lives of advanced colorectal cancer patients and preserve their quality of life.”

The investigators in the phase III FRESCO-2 trial enrolled 691 subjects with advanced refractory metastatic colorectal cancer. Eligible subjects had documented metastatic colorectal cancer and had been previously treated either with chemotherapy, anti-VEGF therapy or immune checkpoint inhibitors.

Eligible patients were randomly assigned to receive fruquintinib (n=461, 5 mg capsule) or matched placebo (n=230) orally once daily on days 1–21 in 28-day cycles, plus best supportive care.

The primary endpoint was overall survival, defined as the time from randomisation to death from any cause.

Median overall survival was 7.4 months in the fruquintinib group versus 4.8 months in the placebo group, a statistically significant difference (p<0·0001).

Grade 3 or 4 treatment-related adverse events occurred in 62.7% of patients in the fruquintinib group and 50.4% in the placebo group. The most frequent events among fruquintinib subjects were hypertension (13.6%), asthenia (7.7%) and hand-foot syndrome (6.4%).

The authors concluded, “Fruquintinib treatment resulted in a significant and clinically meaningful benefit in overall survival compared with placebo in patients with refractory metastatic colorectal cancer. These data support the use of fruquintinib as a global treatment option for patients with refractory metastatic colorectal cancer. Ongoing analysis of the quality of life data will further establish the clinical benefit of fruquintinib in this patient population.”

On May 26, 2023 the U.S. Food and Drug Administration granted priority review status to a new drug application for fruquintinib in the treatment of patients with previously treated metastatic colorectal cancer. If approved, fruquintinib would be the first VEGFR-1, -2, and -3 inhibitor to be available in the United States for the treatment of patients with previously treated metastatic colorectal cancer.