Actinium Pharmaceuticals, Inc. Announces 72% MRD Negativity Rate in the Recently Completed Phase 1 Study of Actimab-A in Combination with Clag-M for Patients with Relapsed or Refractory AML
December 14, 2021 at 08:00 am EST
Actinium Pharmaceuticals, Inc. announced that updated data from the recently complete Actimab-A and CLAG-M Phase 1 combination trial being conducted at the Medical College of Wisconsin (MCW) was presented at the 63rdAmerican Society of Hematology Annual Meeting and Exposition (ASH) that is being held December 11 14, 2021 in Atlanta, Georgia and virtually. This Phase 1 trial was a dose escalation study that evaluated Actimab-A, a CD33 targeting antibody radiation conjugate (ARC) armed with the alpha-emitting radioisotope Actinum-225, combined with CLAG-M (Cladribine, Cytarabine, G-CSF and Mitoxantrone), a salvage chemotherapy regimen for patients fit for intensive therapy. Actimab-A + CLAG-M Phase 1 Results: Complete remissions (CR/CRp) in all dose cohorts, 80% overall response rate (CR/CRp/MLFS) in patients receiving less than 4 lines of prior therapy with a total of 10 complete remissions across all four dose cohorts, 72% MRD negativity rate determined by flow cytometry compares favorably to 39% MRD negativity rate with CLAG-M alone in MCW's institutional experience. 60% response rate in patients receiving prior venetoclax therapy including 4 patients that achieved a complete remission. 75% of patients proceeded to a bone marrow transplant, excluding patients with prior transplant experience, Median time to best response was 40 days, No 30-day mortality, 0.75uCi/kg of Actimab-A identified as recommended Phase 2 dose.