BioCentury
ARTICLE | Clinical News

Daiichi planning NDA for pexidartinib on Phase III TGCT data

June 8, 2018 3:31 PM UTC

Daiichi Sankyo Co. Ltd. (Tokyo:4568) reported data from 120 patients with symptomatic advanced tenosynovial giant cell tumors (TGCT) in the Phase III ENLIVEN trial showing that oral pexidartinib (PLX3397) led to an overall response rate (ORR) at week 25 of 39%, including nine complete responses and 15 partial responses, vs. 0% for placebo (p<0.0001). No responders progressed after a median follow-up of six months. The data were presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago.

The pharma previously reported that pexidartinib met the double-blind, international trial's primary ORR endpoint, but did not report detailed data. The trial enrolled TGCT patients for whom surgical resection of tumors would be potentially associated with worsening functional limitation or severe morbidity (see BioCentury, Nov. 3, 2017)...