Deciphera Pharmaceuticals, Inc. (DCPH) Monday announced positive top-line results from the pivotal Phase 3 MOTION study of its investigational drug Vimseltinib in patients with Tenosynovial Giant Cell Tumor (TGCT). The study met its primary goal.
TGCT is typically benign growths that form around joints.
The MOTION Phase 3 trial, a two-part study, was to evaluate the efficacy and safety of Vimseltinib in patients with TGCT not amenable to surgery.
In part 1, patients were randomized two-to-one to receive either Vimseltinib or placebo. The study met its primary endpoint of Objective Response Rate (ORR) at Week 25 of 40% Compared to 0% for Placebo.
Part 2 portion of the study, in which patients from both the Vimseltinib and placebo arms receive treatment with Vimseltinib, is going on.
The company also announced updated results from the Phase 1/2 study of Vimseltinib in TGCT, in which Vimseltinib showed ORR of 72% in Phase 1 and 64% in Phase 2 studies.
Deciphera expects to submit a New Drug Application (NDA) to the FDA for vimseltinib for the treatment of patients with TGCT in the second quarter of 2024 and a Marketing Authorisation Application (MAA) to the European Medicines Agency in the third quarter of 2024.
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