Fruquintinib reduced the risk of death in patients with advanced metastatic colorectal cancer by 34% and resulted in a longer overall survival than those who received placebo.
In the FRESCO-2 multiregional clinical trial (MRCT) study, the researchers evaluated the efficacy of fruquintinib with best supportive care (BSC) for patients with advanced refractory metastatic colorectal cancer (CRC). The results showed that fruquintinib met the primary endpoint of overall survival (OS) compared to placebo.1
Researchers also observed a significant improvement in progression-free survival (PFS) — the key secondary endpoint — compared to placebo. The results will be presented in an abstract at the European Society for Medical Oncology Congress 2022 on September 12, 2022.1
“These results are exciting and encouraging for both patients and healthcare providers as they address a huge unmet need in refractory metastatic colorectal cancer. Fruquintinib offers a potential new treatment option with a meaningful survival benefit and a manageable toxicity profile,” said Arvind Dasari, associate professor, department of Gastrointestinal Medical Oncology, the University of Texas MD Anderson Cancer Center, in a press release.1
Worldwide, CRC is the third most common cancer and starts in the colon or rectum. In 2020, there were an estimated 915,000 deaths worldwide. In 2022, it was estimated that 151,000 people in the United States were diagnosed with the disease, and data shows that about more than a third of these patients died.1
CRC is the second most common cancer in Europe. In 2020, approximately 507,000 new cases were diagnosed, with approximately 47% of cases resulting in death. It is also the most common cancer in Japan, with 147,000 new cases diagnosed in 2020.1
The Phase 3 FRESCO-2 trial, conducted in the United States, Europe, Japan and Australia, is an MRCT evaluating the efficacy of fruquintinib with BSC in patients with advanced metastatic CRC. Researchers identified 691 patients for the study — 461 of whom took fruquintinib and 230 the placebo — and had a median follow-up of 11 months.1
Fruquintinib, taken in addition to the BSC, met the primary endpoint of OS for patients with metastatic CRC. These patients progressed on standard chemotherapy, relevant biologics and/or were intolerant to TAS-102 and/or regorafenib.1
In the fruquintinib group, the median OS was 7.4 months. In the placebo group, the median OS was 4.8 months. In fruquintinib patients, the disease control rate was also more than 3-fold higher than in the placebo group (55.5% and 16.1%, respectively).1
Patients also showed a statistically significant improvement on the secondary endpoint of PFS. The median PFS was 3.7 months for fruquintinib, more than double the PFS of the placebo group (1.8 months).1
Fruquintinib is a selective, potent oral vascular endothelial growth factor receptor (VEGFR)-1, -2 and -3 inhibitor designed to enhance kinase selectivity. VEGFR inhibitors are important to prevent tumor growth through angiogenesis, which occurs when new blood vessels are formed. This formation process can proliferate the growth of new cancerous tissue, allowing it to spread to other parts of the body.2 Fruquintinib can help minimize off-target toxicity, improve tolerability, and provide consistent target coverage.1
In the FRESCO-2 study, fruquintinib demonstrated a consistent safety profile with previous study data. Of the patients, 62.7% had Grade 3 or higher adverse reactions, which was 12.3% more than the placebo group. The most common adverse reactions were hypertension, asthenia and hand-foot syndrome.1
“These results provide opportunities for further development of fruquintinib in other settings and combinations,” Dasari wrote in the press release..1
- HUTCHMED Highlights FRESCO-2 MRCT Data from Phase III Summary of Fruquintinib in Refractory Metastatic Colorectal Cancer from the Upcoming ESMO 2022 Presentation. Globe Newswire. September 7, 2022. Accessed September 8, 2022.
- NishidaN, Yano H, Nishida T, Kamura T, Kojiro M. Angiogenesis in cancer. Website of the National Library of Medicine. September 2, 2006. Accessed September 8, 2022. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1993983/