Data from The American Society of Hematology. - Curated by Marshall Pearce - Date added 10 January 2018
Data from the SEAMLESS study of sapacitabine from Cyclacel Pharma., in acute myeloid leukemia, or AML, were the subject of an oral presentation at the 59th ASH Annual Meeting in Atlanta, Georgia, on 11 December 2017.
The presentation included additional data from a comprehensive analysis of the SEAMLESS dataset with the objective of characterizing the prespecified subgroups of patients, e.g. those with low peripheral white blood cell count, who appeared to have clinically relevant benefit from the investigational treatment regimen. As previously reported, in the intent-to-treat population, the investigational arm of the SEAMLESS study did not reach statistically significant improvement in OS versus an active control. However, improvement in OS was observed in a stratified subgroup of patients with low baseline peripheral white blood cell count. The subgroup comprised approximately two-thirds of the study's population.
Following analysis of the full SEAMLESS data set and database lock, the Company is developing submission materials to support consultations with European and US authorities with the objective of determining potential regulatory pathways.