Population Pharmacokinetic and Exposure-Response Analyses for Ponatinib in the Phase 3 PhALLCON Study.

ABSTRACT: In March 2024, ponatinib received accelerated FDA approval for the treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL) in combination with chemotherapy based on the Phase 3 PhALLCON study (NCT03589326), which demonstrated a higher rate of minimal residual disease (MRD)-negative complete remission (CR) at the end of induction (EOI) with ponatinib (34.4%) versus imatinib (16.7%; p = 0.002). Patients received ponatinib (30 mg QD with reduction to 15 mg QD upon achievement of MRD-negative CR at EOI) or imatinib (600 mg QD) combined with 20 cycles of reduced-intensity chemotherapy (induction: 3 cycles; consolidation: 6 cycles; and maintenance: 11 cycles). Ponatinib pharmacokinetics (PK) were similar in patients in PhALLCON and patients in a prev

SUBMITTER: Hanley MJ 

PROVIDER: S-EPMC11873365 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature