Daiichi's pexidartinib passes Phase III test in TGCT

Daiichi Sankyo Co. Ltd. (Tokyo:4568) said oral pexidartinib (PLX3397) met the primary endpoint of reducing tumor size from baseline to week 25 compared to placebo in the Phase III ENLIVEN trial to treat symptomatic tenosynovial giant cell tumors (TGCT).

The double-blind, international trial enrolled 120 patients for whom surgical resection of tumors would be potentially associated with worsening functional limitation or severe morbidity. Spokesperson Jennifer Brennan declined to disclose the proportion of patients that achieved complete or partial responses in the trial. Secondary endpoints in the trial include patient-reported outcomes, tumor volume score, range of motion and duration of response...