Fruquintinib fails to meet primary endpoint in latest Chi-Med trial
By Josh White
Date: Friday 16 Nov 2018
(Sharecast News) - Hutchison China MediTech announced that the FALUCA trial did not meet the primary endpoint to demonstrate a statistically significant increase in overall survival compared to placebo on Friday.
The AIM-traded firm, which trades as Chi-Med, said FALUCA was its Phase III trial of fruquintinib in advanced non-small cell lung cancer patients in China who have failed two lines of systemic chemotherapy.
It said fruquintinib demonstrated, in FALUCA, a "statistically significant improvement" in all secondary endpoints including progression-free survival, objective response rate, disease control rate, and duration of response, as compared to the placebo.
The safety profile of the trial was in line with that observed in prior clinical studies, Chi-Med reported.
"While the study demonstrates a significant reduction in disease progression in this challenging lung cancer patient population, we are disappointed that this benefit did not translate into an increase in overall survival," said Chi-Med chairman Simon To.
"We remain confident that the high selectivity and lower off-target toxicities of fruquintinib are major points of differentiation.
"The recent first approval of fruquintinib monotherapy for advanced colorectal cancer, the imminent launch in China, and the commencement of several combination collaborations with immunotherapies both in China and in the US, reinforces our belief in fruquintinib."
Fruquintinib was first approved by the National Medical Products Administration of China in September for the treatment of advanced colorectal cancer, becoming the first China-discovered and developed pharmaceutical for a mainstream oncology indication to be unconditionally approved in the country.
Chi-Med has established a manufacturing facility in Suzhou to produce fruquintinib.
The market launch of fruquintinib in colorectal cancer in China, in collaboration with Eli Lilly, was now said to be "imminent".
Fruquintinib is also in multiple ongoing clinical trials in the US and China, including in combination with checkpoint inhibitors, chemotherapy, and other targeted therapy agents.
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