Innate Pharma, a biopharmaceutical company based in Marseille, France, announced that it has fully enrolled 150 patients for its Phase 2 clinical trial “Efficacy Study of Anti-KIR Monoclonal Antibody as Maintenance Treatment in Acute Myeloid Leukemia (AML)” (EffiKIR). The drug, known as IPH2102/BMS-986015 (lirilumab), is one of three product-candidates originating from Innate in clinical trials. It is licensed to Bristol-Myers Squibb, but Innate Pharma is developing lirilumab through Phase 2 trials.
“Therapeutic approaches that prolong complete remission in elderly patients with AML are urgently needed and natural killer cell activation holds the promise of greatly improving survival in these patients,” stated Marcel Rozencweig, Chief Medical Officer, in a news release from Innate Pharma. “Target enrollment in the EffiKIR maintenance trial with lirilumab has been completed as planned, and we are eagerly awaiting the results which are expected by the end of 2015.”
Of interest for this trial is the efficacy of lirilumab in treating elderly individuals with AML in first complete remission. According to Richard Larson, MD, a Professor of Medicine at University of Chicago Pritzker School of Medicine, who is not involved in the trial, complete remission in AML is defined as having normal cell (neutrophil, platelet, and erythrocyte) counts and fewer than 5% blast cells present in the bone marrow, none with a leukemic appearance. Elderly patients tend to have lower rates of remission due to several biological factors.
The primary outcome of the study is leukemia-free survival from the time of first documented relapse up to 48 months. Adverse effects will also be studied from the time of consent to 28 days after the last drug administration or the last patient visit, up to 24 months. Patients were randomized into three groups: 0.1 mg/kg lirilumab, 1 mg/kg lirilumab, or placebo.
According to literature from Innate Pharma, lirilumab blocks the interaction between killer-cell immunoglobulin-like receptors on natural killer cells and ligands. This facilitates natural killer cell activation, allowing the cells to destroy tumor cells.