Birinapant: Preliminary Phase Ib/IIa data

Preliminary data from 9 evaluable MDS patients in the dose-escalation Phase Ib portion of the open-label, U.S. Phase Ib/IIa TL32711-0087 trial showed that birinapant plus azacitidine led to a bone marrow blast count reduction from 25% to 2% at the end of cycle 1 in a patient who received 1 prior cycle of azacitidine as a single agent; a bone marrow blast count reduction from 17% to 2% at the end of cycle 3 in 1 azacitidine-naive patient now scheduled to undergo a hematopoietic stem cell transplant (HSCT); and a bone marrow blast count reduction from 21% to 7% at the end of cycle 2 in 1 patient refractory to single agent azacitidine. No dose-limiting hematological toxicities were reported. The Phase Ib portion is evaluating twice-weekly 11, 13 or 17 mg/m 2 doses of birinapant for 3 of 4 weeks plus azacitidine or twice-weekly 13 or 17 mg/m 2 doses of birinapant for 4 weeks plus azacitidine. ...