Fruquintinib Meets Primary Endpoint of Overall Survival for Metastatic Colorectal Cancer


Fruquintinib reduced the risk of death in patients with advanced metastatic colorectal cancer by 34% and led to longer overall survival than among those given placebo.

In the FRESCO-2 multi-regional clinical trial (MRCT) study, the investigators evaluated the efficacy of fruquintinib with the 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 significant improvement of 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 patients and healthcare providers alike since they address a huge unmet need in refractory metastatic colorectal cancer. Fruquintinib provides a possible new treatment option with a meaningful survival benefit and 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

Globally, CRC is the third most common cancer and starts in the colon or rectum. In 2020, there was an estimated 915,000 deaths globally. Come 2022, it was estimated that 151,000 people in the United States were diagnosed with the disease, with data showing that approximately more than a third of these patients died.1

CRC is the second most common cancer in Europe. An approximate 507,000 new cases were diagnosed in 2020, with about 47% of cases resulting in death. It is also the most common cancer in Japan, and 147,000 new cases were diagnosed in 2020.1

The phase 3 FRESCO-2 study—conducted in the United States, Europe, Japan, and Australia—is an MRCT that evaluated the efficacy of fruquintinib with BSC in advanced metastatic CRC patients. Researchers identified 691 patients for the study—461 of whom took fruquintinib while 230 took the placebo—and had a median follow-up of 11 months.1

Fruquintinib, taken alongside the BSC, met the primary endpoint of OS for patients with metastatic CRC. These patients progressed on standard chemotherapy, relevant biologic agents, and/or were intolerant to TAS-102 and/or regorafenib.1

In the fruquintinib group, median OS was 7.4 months. Among the placebo group, the median OS was 4.8 months. Among fruquintinib patients, the disease control rate was also more than 3 times higher than the placebo group as well (55.5% and 16.1%, respectively).1

Patients showed statistically significant improvement on the secondary endpoint of PFS as well. 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 that was designed to improve kinase selectivity. VEGFR inhibitors are important to prevent tumor growth from angiogenesis, which occurs when new blood vessels form. This formation process can proliferate the growth of new cancer tissue, helping it to spread to other parts of the body.2 Fruquintinib can help to minimize off-target toxicities, improve tolerability, and provide consistent target coverage.1

In the FRESCO-2 study, fruquintinib showed a consistent safety profile with prior study data. Among patients, 62.7% had grade 3 or higher adverse events (AEs), which was 12.3% more than the placebo group. The most common AEs were hypertension, asthenia, and hand-foot syndrome.1

“These results offer opportunities for further development of fruquintinib in other settings and combinations,” wrote Dasari in the press release.1


  1. HUTCHMED Highlights Phase III FRESCO-2 MRCT Data Summary of Fruquintinib in Refractory Metastatic Colorectal Cancer from the Upcoming ESMO 2022 Presentation. Globe Newswire. September 7, 2022. Accessed on September 8, 2022.
  2. NishidaN, Yano H, Nishida TKamura T,Kojiro M. Angiogenesis in Cancer. National Library of Medicine website. September 2, 2006. Accessed on September 8, 2022.
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