HUTCHMED unveils positive outcomes from its Phase III FRESCO-2 study
Category: #health  By Saipriya Iyer  Date: 2022-08-08
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HUTCHMED unveils positive outcomes from its Phase III FRESCO-2 study

HUTCHMED Limited, a prominent commercial-stage, biopharmaceutical firm based out of China, has reportedly announced that its pivotal global Phase III FRESCO-2 clinical trial of fruquintinib to evaluate its investigational use has met the primary overall survival (OS) endpoint in patients suffering from advanced, refractory metastatic CRC (colorectal cancer).

According to reports, the FRESCO-2 clinical study was a global clinical trial conducted across multiple regions in Europe, the U.S., Australia, and Japan to assess the efficacy of fruquintinib and BSC (Best Supportive Care) against placebo and BSC in subjects with metastatic CRC that had moved on to standard chemotherapy plus relevant biologic agents, and had further progressed on, or had become intolerant to regorafenib and/or TAS-102.

Apart from the OS, the key secondary endpoint of statistically-significant improvement within PFS (progression-free survival) was observed during the study. Fruquintinib’s safety profile in the FRESCO-2 study was consistent with the ones in previously reported studies. Complete results of the trial would be showcased in a presentation during an upcoming medical conference.

Prof. Cathy Eng, MD, FASCO, FACP, and David H. Johnson, FRESCO-2’s Steering Committee member and co-PI stated that the completion of the global phase III clinical trial in a timely manner during the pandemic-era isolations showcases the unaddressed need for novel therapeutic agents for metastatic CRC.

Fruquintinib, by meeting the study’s primary endpoint of OS while also snagging the secondary endpoint of PFS, offers a significant and potentially new option for HUTCHMED’s refractory CRC patients.

The drug candidate, as an orally consumed agent, also offers the added convenience of administration for the company’s patients. Based on its profile, the company expects fruquintinib to witness further exploration in clinical trials across different settings in the future.

HUTCHMED owns all the commercial rights to fruquintinib outside of its home-base of China. Meanwhile, in China, where fruquintinib is identified by the brand name of ELUNATE®, the company has partnered with American pharm giant, Eli Lilly and Company, holding the responsibility for that development as well as execution of all medical detailing on-the-ground, including promotion as well as regional and local marketing.

It is to be noted that fruquintinib is currently not approved to be used outside of China as it is still pending approvals from global health agencies.

Source credit: https://www.benzinga.com/pressreleases/22/08/g28390368/hutchmed-announces-that-fruquintinib-global-phase-iii-fresco-2-study-has-met-its-primary-endpoint-



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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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