A trial to look at the use of a drug targeting refractory metastatic colorectal cancer (CRC) has met its primary endpoint of overall survival (OS) in patients with the disease.
China’s HUTCHMED Limited announced today (August 8) that the phase 3 FRESCO-2 trial investigating the use of fruquintinib had met all secondary endpoints too.
The FRESCO-2 study was a multi-regional clinical trial conducted in the US, Europe, Japan and Australia that investigated fruquintinib plus best supportive care (BSC) vs placebo plus BSC in patients with metastatic CRC who had progressed on standard chemotherapy. It also looked at relevant biologic agents and who had progressed on, or were intolerant to, TAS-102 and/or regorafenib.
Significant improvement
In addition to OS, a statistically-significant improvement in progression-free survival (PFS), a key secondary endpoint, was observed.
The safety profile of fruquintinib in FRESCO-2 was consistent with previously reported studies.
Marek Kania, chief medical officer of HUTCHMED International, said: “We are very happy to see the positive outcomes of the FRESCO-2 study which offers a potential new treatment for patients with advanced metastatic colorectal cancer, where the unmet need is very high and patients have limited treatment options.
“Results from the global FRESCO-2 study supplement findings from the original FRESCO study that led to the marketing approval and commercialization of fruquintinib in China. We would like to thank the patients, their families, and the healthcare professionals who participated in this study and helped achieve this important milestone.”
Marketing authorization
The company has been in communication with regulatory agencies globally regarding the FRESCO-2 trial design and conduct and will discuss these data with the agencies in the US, Europe and Japan with the intent to submit marketing authorization applications as soon as possible.
The US Food and Drug Administration (FDA) granted Fast Track Designation for the development of fruquintinib for the treatment of patients with metastatic CRC in June 2020.
Cathy Eng Co-Leader, Gastrointestinal Cancer Research Program, at the Vanderbilt-Ingram Cancer Center said: “Completion of the international FRESCO-2 phase III trial in a timely fashion during the era of COVID-19 isolation demonstrates the unmet need for new therapeutic agents in metastatic colorectal cancer.
“By meeting the primary endpoint of OS with a secondary endpoint of PFS, fruquintinib provides a significant potential new option for our refractory colorectal cancer patients. As an oral agent, fruquintinib also provides added convenience for our patients. Based on fruquintinib’s profile, we will likely see further exploration in future clinical trials in different settings. This is extremely encouraging, and I look forward to seeing the final results.”
Kinase selectivity
Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.
Dr Weiguo Su, chief executive officer and chief scientific officer of HUTCHMED, said: “We are pleased to have successfully completed our first multi-regional clinical trial, FRESCO-2, to support the global registration of fruquintinib. It has already benefited patients with advanced CRC in China since its launch in 2018. It is also being evaluated alone and in combination with other agents in various tumor types in ongoing studies around the world.”