Tagraxofusp and Azaxitadine With or Without Venetoclax in Newly Diagnosed Secondary AML After Hypomethylating Agents

A treatment cycle is 28 days for Cycle 1 and Cycle 2. Tagraxofusp will be administered at 12 mcg/kg IV over 15 minutes (-5 or +15 minutes) daily for 5 consecutive days (or 5 doses over a period not to exceed 10 days if postponement is required to allow for toxicity resolution). Subjects with a marrow CR (See the protocol) after Cycle 2 will continue Tagraxofusp for Cycles 3 to 12 (up to 1 year of treatment) at 12 mcg/kg IV for 5 consecutive days every 28 days. In subjects without a marrow CR after 2 cycles of treatment, azacitidine 75 mg/m2 SQ or IV will be added on Days 1-7 every 28 days for up to 4 additional cycles of treatment.

A treatment cycle is 28 days for Cycle 3 to Cycle 12. Subjects who achieve a marrow CR receiving tagraxofusp only after Cycle 4, will continue tagraxofusp at 12 mcg/kg IV for 5 consecutive days every 28 days until Cycle 12. Subjects who continue to achieve an overall response (CR, CRi, PR, MLFS, marrow CR) receiving tagraxofusp and azacitidine will continue tagraxofusp at 12 mcg/kg IV for 3 consecutive days and azacitidine 75 mg/m2 SQ or IV on Days 1-7 every 28 days until Cycle 12. Please see the protocol. Patients without an overall response to tagraxofusp + azacitidine after completion of 4 cycles of this combination will be discontinued from study treatment.

TAGALONG Trial: Phase II Study of TAGraxofusp and Azacitidine With or Without Venetoclax in Newly Diagnosed Secondary AML after Previous Exposure to HypOmethylatiNG Agents