BAYZF - Hutchmed fruquintinib improves survival meets main goal of colorectal cancer study

Hutchmed (China) ( NASDAQ: HCM ) said its medicine fruquintinib met the main goal of overall survival (OS) in patients with advanced, refractory metastatic colorectal cancer (CRC) in a phase 3 trial.

The study called FRESCO-2 evaluated fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic CRC who had progressed on standard chemotherapy and relevant biologic agents and who had progressed on, or were intolerant to, TAS-102 and/or regorafenib, sold as Stivarga by Bayer ( OTCPK:BAYRY ) ( OTCPK:BAYZF ).

The Chinese drugmaker added that besides OS, a statistically-significant improvement was seen in progression-free survival (PFS - length of time during/after therapy that a patient lives with the disease without it getting worse), a key secondary goal of the study.

Overall safety was consistent with fruquintinib's known profile, the company said in an Aug. 7 press release.

Hutchmed noted that it will discuss the data with regulatory agencies in the U.S., Europe and Japan with the intent to file for approval of the drug as soon as possible.

"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," said Marek Kania, executive vice president, managing director and chief medical officer of Hutchmed International.

Fruquintinib is approved and marketed as Elunate in China, where it has partnered with Eli Lilly ( NYSE: LLY ). Hutchmed noted that it retains all commercial rights to fruquintinib outside of China.

HCM +2.67% premarket to $14.25

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