Deciphera’s Vimseltinib Could Benefit From Liver Safety, Prescriber Overlap in TGCT

Positive topline results from the Phase III MOTION trial showed none of the liver toxicity that earned Daiichi Sankyo’s Turalio a boxed warning and REMS in tenosynovial giant cell tumor.

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Deciphera Pharmaceuticals, Inc.’s Phase III vimseltinib has a potentially smooth path to market in tenosynovial giant cell tumor (TGCT) thanks to a safety profile more benign than a competing drug for the condition already on the market. Decipher should also benefit from marketing to physicians that mostly overlaps with the one that Deciphera targets for its drug for gastrointestinal stromal tumors (GIST).

The Waltham, MA-based company announced 30 October positive topline results from the Phase III MOTION study of vimseltinib as well as updated Phase I/II results from a study of the drug in the same indication. MOTION met its primary endpoint of objective response rate (ORR) and all key secondary endpoints at week 25 compared with placebo

Key Takeaways
  • Vimseltinib showed a positive improvement in objective response rate compared with placebo in the Phase III MOTION trial, but no cholestatic hepatotoxicity.

  • The lack of the potentially fatal liver toxicity, plus Deciphera’s existing commercial infrastructure for Qinlock, could give vimseltinib a significant market advantage

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