Fruquintinib improved overall survival compared with placebo in patients with refractory metastatic colorectal cancer.
Patients with refractory metastatic colorectal cancer treated with fruquintinib derived a more significant survival benefit compared with those treated with placebo, recent study findings demonstrated.
Fruquintinib is a highly selective oral inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, according to the study published in The Lancet. VEGF inhibitors aim to block the enzyme necessary to form blood vessels for tumors.
“These data support the use of fruquintinib as a global treatment option for patients with refractory metastatic colorectal cancer,” the researchers wrote in the study results. “Ongoing analysis of the quality-of-life data will further establish the clinical benefit of fruquintinib in this patient population.”
In the phase 3 FRESCO-2 trial, researchers analyzed data from 691 patients with metastatic colorectal adenocarcinoma who were previously treated with all currently approved targeted and cytotoxic (a substance that kills cancer cells) therapies. These patients also progressed on or were intolerant to Lonsurf (trifluridine and tipiracil), Stivarga (regorafenib) or both.
Patients were assigned either fruquintinib (461 patients) or placebo (230 patients). Both treatment groups also received best supportive care.
Researchers focused on a primary outcome of overall survival, defined as the time from when a patient received their treatment assignment to all-cause death.
Regarding previous treatment, patients enrolled in this study underwent a median of four lines of previous systemic therapy for metastatic disease. In addition, 73% of patients received more than three lines of therapy.
The fruquintinib group had a median overall survival of 7.4 months compared with 4.8 months in the placebo group.
Side effects considered severe or worse occurred in 63% of patients assigned fruquintinib and in 50% of those assigned placebo. The most common side effects graded severe or worse in patients treated with fruquintinib included high blood pressure (14%), weakness (8%) and hand-foot syndrome (6%), which is a condition that results in swelling, pain, tingling, numbness or redness of the hands and feet.
Each group had one death associated with the assigned treatment. In particular, the patient assigned fruquintinib died from intestinal perforation (a hole through the intestines) and the patient assigned placebo died from cardiac arrest (when the heart suddenly and unexpectedly stops pumping).
The FRESCO-2 trial is currently ongoing but is not recruiting patients, according to its listing on ClinicalTrials.gov. Its estimated study completed date is March 2024.
Earlier in 2023, the Food and Drug Administration granted a primary review for a new drug application to fruquinitib for patients with previously treated metastatic colorectal cancer.
“We are confident that fruquintinib has the potential to transform the treatment landscape for those living with previously treated metastatic colorectal cancer, as demonstrated by its strong clinical profile,” Dr. Awny Farajallah, head of global medical affairs oncology at Takeda, the drug’s manufacturer, said in a press release. “There are significant needs for patients with this disease in the U.S., and we believe fruquintinib has the potential to address these needs regardless of patients’ biomarker status. We look forward to continuing conversations with the FDA with the goal to make this therapy available to patients as soon as possible.”
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