Sapacitabine: Additional Ph III SEAMLESS data

The open-label, international Phase III SEAMLESS trial in 491 newly diagnosed AML patients ages ≥70 years who were not candidates for, or who refused, intensive induction chemotherapy showed that alternating cycles of sapacitabine and Dacogen decitabine missed the primary endpoint of improving OS vs. Dacogen alone. Cyclacel said the sapacitabine combination improved OS vs. Dacogen monotherapy in a subgroup of patients with low peripheral white blood cell counts at baseline, about two-thirds of all enrolled patients. Additionally, the combination improved complete remission rate, a secondary endpoint, in patients who had discontinued therapy at the time of analysis. The company said other endpoints and safety were similar between treatment arms. Patients received 20 mg/m² IV decitabine for 5 consecutive days of a 4-week cycle alternating with 300 mg sapacitabine twice daily 3 times a week for 2 weeks of a 4-week cycle...