Written by Tom Wilemon
A new treatment is on the horizon for patients with metastatic colorectal cancer who have run out of treatment options.
Results of international clinical trials, Posted on June 15th lancetshowed that fruquintinib, a selective targeted therapy, resulted in statistically significant improvements in overall survival and progression-free survival. Median survival for patients who received fruquintinib was 7.4 months versus 4.8 months for patients who received placebo and best supportive care, and progression-free survival was 3.7 months versus 1.8 months. Participants who received fruquintinib had a 34% reduction in death compared to the placebo group. At 6 months, 24% of patients in the fruquintinib group were progression-free, compared with 1% in the placebo group.
The FRESCO-2 clinical trial of fruquintinib was conducted at 124 sites in 14 countries. The study looked at patients with metastatic colorectal cancer who had not responded to other treatments and had received a median of four prior treatments.
Kathy Eng, MD, David H. Johnson Professor of Surgery 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, will co-lead the international trial. led. Investigator. she, lancet.
“The majority of stage IV patients have disease that cannot be surgically resected. Therefore, we must continue to pursue new treatment options to extend patients’ overall survival while preserving their quality of life. These results from the international FRESCO-2 validated the results of the Phase III FRESCO trial, which was conducted only in China. We look forward to FDA approval, as well as approval from the European Medicines Agency and Japan Pharmaceuticals and Medical Devices Agency, to make fruquintinib available to all patients with metastatic colorectal cancer. I am.”
At 9 months, the proportion of patients still alive was 41% in the fruquintinib group and 28% in the placebo group. The median duration of response to fruquintinib was 10.7 months. Some patients were super responders. The longest duration of response reported by a patient was 16.9 months.
The study included 691 patients who were assigned in a 2:1 ratio to either fruquintinib or placebo. The number of patients in the fruquintinib group was 461 and the number in the placebo group was 230.
Fruquintinib is an oral drug that selectively targets and inhibits vascular endothelial growth factor receptors (VEGFR 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) granted Fast Track designation to fruquintinib in June 2020, and on March 31, the pharmaceutical company with U.S. licensing rights formally submitted a new drug application to the FDA.Research published in lancet Final efficacy analysis of fruquintinib from the FRESCO-2 trial.
Currently, the United States lacks effective approved treatments for metastatic colorectal patients who have progressed on standard therapy, demonstrating an unmet need for new treatment options.
An updated analysis as of the 2023 ASCO Annual Meeting demonstrated that fruquintinib was shown to be well tolerated by patients in the FRESCO-2 trial. The most frequent adverse events leading to dose reduction were hand-foot syndrome (3%), hypertension (3.3%). Overall, less than 0.5% of all patients discontinued treatment due to treatment-related toxicities.
Heavily pretreated patients in the clinical trial showed improvement with fruquintinib, regardless of prior therapy. Approximately 50% of colorectal cancer patients develop distant metastases, and the 5-year overall survival rate for these patients is only 15%.