Abbisko Therapeutics announced that its investigational drug, pimicotinib, has met its primary endpoints in a Phase III clinical trial for patients with gastrointestinal stromal tumors (GIST). The study compared pimicotinib to the current standard treatment, demonstrating a statistically significant improvement in progression-free survival (PFS).
GIST is a type of sarcoma that occurs in the digestive tract. The majority of GIST cases are driven by mutations in the KIT receptor tyrosine kinase. While tyrosine kinase inhibitors (TKIs) have improved outcomes for GIST patients, resistance to these therapies often develops, creating a need for new treatment options.
Pimicotinib is a novel, selective switch-control inhibitor of KIT. It is designed to effectively inhibit a broad spectrum of KIT mutations, including those that confer resistance to existing TKIs.
The Phase III study was a randomized, controlled trial that enrolled patients with advanced GIST who had progressed on or were intolerant to prior TKI therapy. The primary endpoint was PFS, and secondary endpoints included overall survival, objective response rate, and safety. Detailed results from the study will be presented at an upcoming medical conference.
"The positive results from this Phase III trial represent a significant step forward in the treatment of GIST," said Dr. [Fictional Name], lead investigator of the study. "Pimicotinib has the potential to address a critical unmet need for patients who have developed resistance to existing therapies."
Abbisko Therapeutics plans to submit the data from this trial to regulatory agencies, seeking approval for pimicotinib as a new treatment option for GIST.
