Daiichi Sankyo’s ENLIVEN Phase 3 Study of Pexidartinib Met Primary Endpoint in TGCT

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the pivotal phase 3 placebo-controlled ENLIVEN (NCT02371369) study of pexidartinib met its primary endpoint of tumor response as measured by tumor size reduction in patients with symptomatic tenosynovial giant cell tumor (TGCT) where surgical resection is potentially associated with worsening functional limitation or severe morbidity. A comprehensive evaluation of the benefit/risk for TGCT based on the totality of the pexidartinib program is now underway and will guide next steps.

Pexidartinib is an investigational agent that has not been approved for any indication and safety and efficacy have not been established.