Dr. Stein on the SELECT-AML-1 Trial in Newly Diagnosed AML

Eytan M. Stein, MD, director, Program for Drug Development in Leukemia, Division of Hematologic Malignancies, Memorial Sloan Kettering Cancer Center, discusses the phase 2 SELECT-AML-1 trial (NCT04905407) in patients with newly diagnosed acute myeloid leukemia (AML).

The phase 2 SELECT-AML-1 trial is examining the utilization of tamibarotene (Amnolake) plus venetoclax (Venclexta) and azacitidine (Vidaza) in patients with retinoic acid receptor alpha (RARA)–positive AML who are unlikely to tolerate standard intensive chemotherapy as a frontline treatment.

The first part of the trial will examine the safety of combining tamibarotene with venetoclax and azacitidine, followed by the second part of the study where patients will be randomized 1:1 to receive venetoclax and azacitidine with or without tamibarotene, Stein explains.

Notably, a subset of patients receiving venetoclax and azacitidine alone will be permitted to cross over to receive tamibarotene with venetoclax and azacitidine if they fail on treatment, Stein continues. The primary end points of SELECT-AML-1 will be complete remission rates and overall response rates, and exploratory end points included pharmacokinetics and additional safety, Stein concludes.