Vimseltinib confers superior response rate in tenosynovial giant cell tumor
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Vimseltinib improved objective response rate compared with placebo for patients with tenosynovial giant cell tumor, according to topline data from the agent’s manufacturer.
Safety results from the pivotal phase 3 MOTION trial suggest no cholestatic hepatotoxicity with use of the investigational agent.
Vimseltinib (Deciphera Pharmaceuticals) is an orally administered switch-control kinase inhibitor of CSF1R.
The two-part MOTION trial assessed the efficacy and safety of vimseltinib in patients with tenosynovial giant cell tumor (TGCT) not amenable to surgery without prior anti-CSF1/CSF1R therapy.
During part one of the double-blind-study, researchers randomly assigned 123 patients in a 2:1 ratio to receive either vimseltinib 30 mg twice weekly (n = 83) or placebo (n = 40) for 24 weeks.
The study met its primary endpoint for objective response rate in the intent-to-treat population, as vimseltinib demonstrated “statistically significant and clinically meaningful improvements” compared with placebo at week 25, according to Deciphera-issued press release.
Researchers noted an ORR at week 25 of 40% (95% CI, 29-51) among patients in the vimseltinib arm and 0% (95% CI, 0-9) in the placebo arm.
Additionally, the study met all key secondary endpoints assessed at week 25, including ORR per tumor volume score, active range of motion, physical function, stiffness, quality of life and pain.
“Patients suffering from TGCT are in need of a new treatment option that offers both strong clinical benefit and a well-tolerated safety profile,” Hans Gelderblom, MD, PhD, chair of the department of medical oncology at Leiden University Medical Center, said in the release. “TGCT has a significant negative impact on the daily life of patients who face substantial pain, stiffness and impaired mobility. Success across both the primary and all key secondary endpoints in MOTION underscores vimseltinib’s ability to help [patients with] TGCT feel and function better.”
Researchers reported vimseltinib’s safety profile in the MOTION trial to be consistent with previously disclosed data. Notably, 6% of patients discontinued treatment due to treatment-emergent adverse events.
Deciphera said it plans to submit a new drug application to the FDA for vimseltinib for the treatment of patients with TGCT in the second quarter of 2024, in addition to sharing further results from part one of the MOTION trial at an upcoming major medical meeting.
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