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New Treatment Increases Metastatic Colorectal Cancer Survival in Trial

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A new therapy is on the horizon for patients with metastatic colorectal cancer who have run out of treatment options.


Results from an international clinical trial, published June 15 in The Lancet, show that the selective targeted therapy, Fruquintinib, resulted in a statistically significant improvement in overall survival and progression-free survival.  Patients who received fruquintinib had a median survival rate of 7.4 months compared to 4.8 months for patients who received placebo plus best supportive care and progression-free survival of 3.7 months vs. 1.8 months. Participants who received fruquintinib had a 34% reduction in death compared to the placebo group. At six months, 24% of patients on fruquintinib were progression free versus 1% on placebo.

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The FRESCO-2 clinical trial for fruquintinib was conducted at 124 sites across 14 countries. The study recruited patients with metastatic colorectal cancer who had not responded to other treatments and who had received a median of four prior lines of therapy.


Cathy Eng, MD, the David H. Johnson Professor of Surgical and Medical Oncology, professor of Medicine at Vanderbilt University Medical Center and co-leader of the Gastrointestinal Cancer Research Program at Vanderbilt-Ingram Cancer Center, led the international trial as co-principal investigator. She is also the lead senior author of the study published in The Lancet.


“The majority of stage IV patients will have surgically unresectable disease.  Hence, we must continue to pursue new treatment options to extend the overall survival of our patients with quality of life. These findings from international FRESCO-2 validated the findings of the phase III FRESCO trial which was conducted only in China.  Here we have a promising agent with overwhelming single agent activity.  I look forward to the FDA approval as well as approvals from the European Medicines Agency and the Pharmaceuticals and Medical Devices Agency in Japan, so we can offer fruquintinib to all metastatic colorectal cancer patients,” said Eng.


The proportion of patients who were still alive at nine months was 41% in the fruquintinib group and 28% in the placebo group. The median duration of response for fruquintinib was 10.7 months. Some patients were super responders. The maximum duration of response by a patient was ongoing at 16.9 months.


The trial involved 691 patients, who were assigned by a 2:1 ratio to either receive fruquintinib or placebo. The fruquintinib arm numbered 461, while the placebo group numbered 230.


Fruquintinib is an oral medication that selectively targets and inhibits vascular endothelial growth factor receptors (VEGFRs 1,2, and 3), which regulate the development of new blood vessels associated with tumor growth and cancer metastasis. The U.S. Food and Drug Administration (FDA) in June 2020 granted fruquintinib fast track designation, and on March 31, the pharmaceutical company with the U.S. licensing rights formally submitted the new drug application to the FDA. The study published in The Lancet is the final efficacy analysis of fruquintinib from the FRESCO-2 trial.


Currently, there is a paucity of approved effective treatments in the U.S. for metastatic colorectal patients who have progressed on standard treatments, demonstrating the unmet need for new treatment options.


The updated analysis as of the Annual ASCO Meeting 2023 demonstrated that the FRESCO-2 trial showed that fruquintinib was well tolerated by patients. The most frequent adverse events leading to dose reduction were hand-foot syndrome (3%), hypertension (3.3%). Overall, fewer than 0.5% of all patients discontinued therapy due to a treatment related toxicity.


Improvements with fruquintinib were seen regardless of treatment with prior therapies in the heavily pretreated patients who participated in the clinical trial. Approximately 50% of patients with colorectal cancer will develop distant metastases, and the five-year overall survival rate for these patients is only 15%.


Reference: Dasari A, Lonardi S, Garcia-Carbonero R, et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study. The Lancet. 2023;0(0). doi: 10.1016/S0140-6736(23)00772-9



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