Actimab-A Phase I/II trial interim data demonstrate extension of overall survival to 9.1 months in elderly secondary acute myeloid leukemia
Actinium Pharmaceuticals, Inc., a biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, today announced positive interim data from the ongoing Phase I/II trial of Actimab-A in older patients with newly diagnosed Acute Myeloid Leukemia (“AML”). Most notably, median overall survival (“OS”) of the seven secondary AML patients (with prior myelodysplastic syndrome, or MDS) in the study was 9.1 months, which is a prolongation of life compared to historical norms of typically 2 to 5 months.1 Older AML patients are already higher risk, with secondary AML patients considered to have the more severe and less treatable form of AML, and the shortest expected survival. The clinical abstract will be published and available online in Blood, the official Journal of the American Society of Hematology.
“Alpha emitting isotopes may result in more efficient leukemia cell killing without the toxicity of intensive chemotherapy,” said Joseph Jurcic, M.D., Professor of Medicine and Director of the Hematologic Malignancies Section of the Hematology/Oncology Division at Columbia University Medical Center, and lead study investigator. “In this study, Actimab-A was safely and effectively combined with low-dose chemotherapy in older AML patients. Even at this early stage in development, the tolerability of the regimen and promising survival data in this poor-risk population are highly encouraging and support our center’s commitment to this program. Because many of these patients cannot tolerate intensive chemotherapy, potentially less toxic treatments such as this are desperately needed.”
“We believe the data presented provide further evidence that Actimab-A has substantial clinical activity, including a survival benefit, in the hardest to treat AML patients,” said Dragan Cicic MD, Chief Medical Officer of Actinium. “The potential efficacy in killing other treatment resistant leukemia cells combined with the limited side effects identified in the study to date could offer a new hope to patients whose age, comorbidities and nature of disease currently leaves them with very limited treatment options. We continue to work with a world-class team of clinical investigators to advance this program and technology.”
The interim analysis from this company-sponsored trial is consistent with results from the prior three trials in Actinium’s HuM195-Alpha Program. The abstract, Phase I Trial of Targeted Alpha-Particle Therapy Using Actinium-225 (225Ac)-Lintuzumab (Anti-CD33) in Combination with Low-Dose Cytarabine (LDAC) for Older Patients with Untreated Acute Myeloid Leukemia (AML), will be published and available online in Blood, the official Journal of the American Society of Hematology.
1. Oran B, and Weisdorf DJ. Survival for older patients with acute myeloid leukemia: a population-based study. Haematologica 2012; 97(12):1916-1924. doi:10.3324/haematol.2012.066100.
N Okuyama et al, Prognosis of acute myeloid leukemia transformed from myelodysplastic syndromes: A multicenter retrospective study, Leukemia Research 37 (2013) 862- 867
Phase I Trial Of The Targeted Alpha-Particle Nano-Generator Actinium-225 (225Ac)-Lintuzumab (Anti-CD33) In Combination With Low-Dose Cytarabine (LDAC) For Older Patients With Untreated Acute Myeloid Leukemia (AML), Joseph G. Jurcic, MD, Farhad Ravandi, MD, John M. Pagel, MD, PhD, Jae H Park, MD, Dan Douer, MD, Elihu H. Estey, MD, Hagop M Kantarjian, MD, Dragan Cicic, MD, and David A. Scheinberg, MD, PhD, Blood, published online November 2014.
Source: Actinium Pharmaceuticals