Viewpoint enliven trial

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Promising clinical benefit of pexidartinib is offset by serious hepatic toxicities in some patients Date: 04 Jun The ENLIVEN study was halted despite meeting the primary endpoint Enrolment into the pexidartinib arm was halted 6 patients short of target due to 2 cases of non-fatal, serious hepatic toxicity, and the entry of patients into the part 2 placebo arm was also stopped.

Significant clinical benefit in terms of physical function were observed with pexidartinib All secondary endpoints were also met: The ORR by tumour volume scores were Customise settings Accept all cookies.

One patient with advanced cancer and ongoing liver toxicity died and one patient required a liver transplant. The mechanism of cholestatic hepatotoxicity is unknown and its occurrence cannot be predicted.

It is unknown whether liver injury occurs in the absence of increased transaminases. Please see Adverse Reactions. Monitor liver tests weekly for the first month after rechallenge. Further information is available at turalioREMS. Part one was a double-blind study in which patients with symptomatic, advanced TGCT for whom surgery was not recommended were randomly assigned via an integrated web response system to the pexidartinib or placebo group. Individuals in the pexidartinib group received a loading dose of mg pexidartinib per day orally mg morning; mg evening for the first 2 weeks, followed by mg per day mg twice a day for 22 weeks.

Part two was an open-label study of pexidartinib for all patients. The primary endpoint, assessed in all intention-to-treat patients, was overall response at week 25, and was centrally reviewed by RECIST, version 1.

Safety was analysed in all patients who received at least one dose of the study drug.