The P-II (APEX) trial evaluated bezuclastinib in patients with AdvS. The updated data will be expected at the end of 2022
As of the data cutoff date of May 2022, 11 patients were evaluated for signs of clinical activity, all patients achieved a ≥50% reduction in serum tryptase levels with a median reduction of 89% & 6 achieved a reduction to <20 ng/mL. All 8 bone marrow biopsy-assessed patients achieved ≥50% bone marrow mast cells reduction & 6 with complete clearance
8 patients showed a reduction in KIT D816V VAF, 3 discontinued avapritinib for toxicity reasons, clinical outcomes consistent with avapritinib-naïve patients, were well-tolerated with no reported periorbital or peripheral edema, cognitive effects, or intracranial bleeding events
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