HUTCHMED (China) Limited (HCM) announced Monday that the pivotal global Phase 3 FRESCO-2 trial evaluating the investigational use of fruquintinib met its primary endpoint of overall survival in patients with advanced, refractory metastatic colorectal cancer or CRC.
The full results will be submitted for presentation to an upcoming medical meeting, and the company’s plans for regulatory submissions are underway in the U.S., Europe and Japan.
In Hong Kong, HUTCHMED shares were gaining around 6.3 percent to trade at HK$22.80.
CRC, the third most common cancer worldwide, starts in either the colon or rectum.
The FRESCO-2 study was a multi-regional clinical trial conducted in the U.S., Europe, Japan and Australia that investigated fruquintinib plus best supportive care or BSC vs placebo plus BSC. The involved patients with metastatic CRC had progressed on standard chemotherapy and relevant biologic agents and had progressed on, or were intolerant to, TAS-102 and/or regorafenib.
In addition to OS, a statistically-significant improvement in progression-free survival, a key secondary endpoint, was observed. The safety profile of fruquintinib in FRESCO-2 was consistent with previously reported studies.
HUTCHMED said it has been in communication with regulatory agencies globally regarding the FRESCO-2 trial design and conduct. The company will discuss these data with the agencies in the U.S., Europe and Japan with the intent to submit marketing authorization applications as soon as possible.
The U.S. FDA granted Fast Track Designation for the development of fruquintinib for the treatment of patients with metastatic CRC in June 2020.
HUTCHMED retains all commercial rights to fruquintinib outside of China. In China, where fruquintinib is marketed under the brand name ELUNATE, HUTCHMED is partnered with Eli Lilly and Co. (LLY). Fruquintinib is not approved for use outside of China.
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