Benzinga - by Vandana Singh, Benzinga Editor.
Deciphera Pharmaceuticals Inc (NASDAQ: DCPH) announced top-line results from the MOTION Phase 3 study of vimseltinib in patients with Tenosynovial Giant Cell Tumor (TGCT) not amenable to surgery.
The study met its primary endpoint in the intent-to-treat (ITT) population, demonstrating statistically significant and clinically meaningful improvement versus placebo in Objective Response Rate (ORR) at Week 25 of 40% for the vimseltinib arm and 0% for the placebo arm.
MOTION study met all key secondary endpoints with statistically significant and clinically meaningful improvements at Week 25 compared to placebo, including ORR by Tumor Volume Score (TVS) of 67% vs. 0%.
Treatment with vimseltinib also demonstrated an improvement in mean change from baseline in active active range of motion (ROM) at Week 25 of 18.4% versus a 3.8% improvement for placebo.
Vimseltinib was well-tolerated, and the safety profile in the MOTION study was consistent with previously disclosed data. There was no evidence of cholestatic hepatotoxicity in patients treated with vimseltinib.
The company expects to submit a marketing application to the FDA for vimseltinib for TGCT in the second quarter of 2024 and a Marketing Authorisation Application (MAA) to the European Medicines Agency in the third quarter of 2024.
The company also released updated results from the Phase 1/2 study of vimseltinib, demonstrating a Best ORR of 72% (Phase 1) and 64% (Phase 2 Cohort A) with a median treatment duration of 25.1 months (Phase 1) and 21.0 months (Phase 2 Cohort A).
The company reported Q3 revenues of $43.31 million, up 20%, beating the consensus of $39.35 million.
EPS loss reached $(0.58), up from $(0.55) a year ago, beating the consensus of $(0.61).
Deciphera Pharmaceuticals' cash, cash equivalents, and marketable securities of $376.9 million will provide a cash runway into 2026.
Price Action: DCPH shares are up 21.60% at $12.35 on the last check Monday.
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