Deciphera to Present MOTION Phase 3 Vimseltinib Results for TGCT at 2024 ASCO and The Lancet

Deciphera Pharmaceuticals LLC, a biopharmaceutical company recognized for its innovative cancer treatments, has recently unveiled promising results from its MOTION Phase 3 clinical trial for vimseltinib, aimed at treating tenosynovial giant cell tumor (TGCT). These findings were discussed in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, and published in The Lancet.

Dr. Hans Gelderblom, from Leiden University Medical Center, emphasized that the MOTION trial results highlight vimseltinib’s potential to meet the significant medical need for an effective and well-tolerated TGCT therapy. Vimseltinib not only exhibited robust antitumor efficacy but also showed substantial improvements in quality-of-life measures for patients.

Dr. Matthew L. Sherman, Deciphera's Executive Vice President and Chief Medical Officer, expressed enthusiasm about the detailed data, revealing that vimseltinib significantly improved multiple secondary endpoints and maintained a favorable safety profile. Deciphera plans to submit a New Drug Application (NDA) for vimseltinib in the second quarter of 2024, followed by a Marketing Authorization Application (MAA) in the third quarter of 2024, aiming to make this treatment globally accessible for TGCT patients.

The MOTION Phase 3 trial was a two-part, randomized, double-blind, placebo-controlled study focusing on patients with TGCT who were not candidates for surgery and had not received prior anti-CSF1/CSF1R therapy. In the first part of the study, 123 patients were randomized in a 2:1 ratio to receive either 30 mg of vimseltinib or a placebo twice weekly for 24 weeks. The efficacy data were based on a cutoff date of August 22, 2023, while the ongoing open-label Part 2 allows all participants to receive vimseltinib.

The primary endpoint of the trial was the Overall Response Rate (ORR) at Week 25, as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 through an independent radiologic review. The results were compelling, with the vimseltinib arm showing an ORR of 40% compared to 0% in the placebo group, demonstrating a highly significant difference.

Additionally, the study met all six key secondary endpoints at Week 25, including ORR by tumor volume score (TVS), active range of motion (ROM), physical function, stiffness, quality of life, and pain. Notably, the ORR by TVS was 67% for vimseltinib, and patients experienced marked improvements in ROM, physical function, stiffness, and quality of life measures. The treatment was well-tolerated, with most adverse events being mild to moderate and no signs of cholestatic hepatotoxicity or severe liver injury.

In conjunction with the MOTION trial findings, Deciphera will present a trial-in-progress poster for its ongoing Phase 1/2 study of DCC-3116 in combination with ripretinib at the ASCO Annual Meeting. This study evaluates the safety, tolerability, and efficacy of the combination treatment for advanced gastrointestinal stromal tumor (GIST) patients.

Deciphera Pharmaceuticals is committed to developing innovative therapies for cancer patients through its expertise in kinase biology. The company's portfolio includes multiple clinical-stage product candidates, with QINLOCK® as its flagship treatment for fourth-line GIST, already approved in various international markets.

These advancements underscore Deciphera's dedication to addressing significant unmet medical needs and improving the lives of patients worldwide.

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