PMV Pharmaceuticals (PMVP) provided an update on the Phase 2 monotherapy and Phase 1b combination portions of the ongoing PYNNACLE clinical trial. Enrollment on track in registrational Phase 2 portion of PYNNACLE clinical trial evaluating rezatapopt; more than 75% of sites activated across the U.S., Europe, and Asia-Pacific; interim analysis expected by mid-2025. Dose-limiting toxicities observed in rezatapopt and Merck’s (MRK) anti-PD-1 therapy KEYTRUDA combination arm of Phase 1b PYNNACLE trial; rezatapopt 500 mg once-daily in combination with pembrolizumab 200 mg every three weeks established as maximum tolerated dose; due to limited clinical benefit at this dose, PMV is discontinuing enrollment in the Phase 1b combination arm. PMV Pharmaceuticals is collaborating with MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center to support an investigator-initiated Phase 1b study evaluating rezatapopt monotherapy and in combination with azacitidine in patients with recurrent or refractory AML/MDS harboring a TP53 Y220C mutation
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