DCC-3014, Vimseltinib (Deciphera) is the name of a medication currently under investigation as a treatment for TGCT.
Previously, a Phase 2/3 study was conducted, meaning the side effects were evaluated as well as the effectiveness of the drug. The Phase 3 trial is known as MOTION.
Published data shows it is relatively safe and effectively shrinks TGCT in 40% of patients and reduces disease-related symptoms such as pain, stiffness, and improving range of motion (1). Other measurements for tumor shrinkage, such as tumor volume, demonstrate that vimseltinib shrinks TGCT in 67% of patients. Volume-based measurements may better capture drug response because TGCTs aren’t only 2-dimensional and therefore, measuring diameters does not represent the full picture. TGCT may change in volume but not in length, for example.
Common side effects identified in 32 patients in the Phase 1 and 36 patients in the Phase 2 include increases in creatine phosphokinase (63% in Phase 1 and 53% in Phase 2), facial swelling (53% in Phase 1 and 22% in Phase 2), fatigue (47% in Phase 1 and 17% in Phase 2), increases in liver enzymes (44 and 33%), muscle aches (28% in the Phase 1 and 14% in the Phase 2), itching (25% in Phase 1 and 8% in Phase 2), among others (data). Side effects in the Phase 3 study were largely similar with itching (30%), rash (20%), facial swelling (45%), fatigue (33%), and lab abnormalities like creatinine kinase (24%).
MOTION has closed recruitment for its 18 different global clinical locations. Vimseltinib or a sugar drug (placebo) was given twice weekly for 24 weeks. Following 24 weeks, Vimseltinib was given to all participants. The objective of this trial was to evaluate tumor shrinkage at 25 weeks, range of motion, and patient reported pain, stiffness, and function. Results from the Phase 3 trial show that 40% of patients (33 out of 83 patients that received vimseltinib) had a response at 6 months compared to none of those that received the placebo. Patients treated with Vimseltinib reported reduced pain, stiffness, and improved range of motion following 6 months of treatment.
Following the Phase 3 trial, it is expected that vimseltinib will go through the approval process with regulatory bodies. It is currently unknown when Vimseltinib will be approved.
For more information on the trial results, check out the lay language summary, or ask your healthcare provider.
To learn more, check out Deciphera's Vimseltinib page.
