On 21st March 2017, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) gave Positive Scientific Advice for a trial of iomab-B (a radioimmuno conjugate of a murine monoclonal antibody that targets CD45 [an antigen widely expressed on leukemia cells]) in patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML). The EMA previously awarded orphan designation to iomab-B in October 2016.
Currently in the United States (U.S), iomab-b is being explored in a pivotal phase 3 SIERRA study (NCT02665065), which is aiming to evaluate the efficacy of iomab-B in conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic Hematopoietic Cell Transplant (HCT) in 150 patients (55 years and above) with R/R AML. The primary and secondary endpoints of this study were durable complete remission at 6 months and overall survival at 1 year, respectively.
On the phase 3 SIERRA trial, the EMA CHMP remarked that the trial design, primary endpoint, and planned statistical analysis are satisfactory and can serve as the basis for submission of a Marketing Authorization Application. Additionally, the EMA noted that it does not anticipate the need for further standalone preclinical toxicology or safety studies. However, supporting data and information that are already being collected as part of the U.S. pivotal phase 3 SIERRA trial were requested by the EMA.
Iomab-B, once approved, is intended to be an induction and conditioning agent prior to HCT in R/R AML patients.