Syros Pharmaceuticals (NASDAQ: SYRS) has announced it will halt enrollment in the SELECT-AML-1 Phase 2 trial, which is assessing the triplet combination of tamibarotene, venetoclax, and azacitidine versus the doublet regimen of venetoclax and azacitidine for newly diagnosed, unfit AML patients with RARA gene overexpression. This decision follows an interim analysis revealing no significant difference in the response rates between the triplet and doublet arms. Data from 51 patients, reviewed on August 9, 2024, showed similar response rates in both treatment arms (triplet: 65%, doublet: 70%). No new safety concerns were noted. Patients will have the option to continue on the study at the discretion of investigators. Syros will present detailed findings at the 12th Annual SOHO Meeting in September 2024.
Dr. David A. Roth, Syros’ Chief Medical Officer, expressed disappointment over the trial’s results but remains optimistic about the doublet regimen’s potential in higher-risk MDS. The company continues to advance the SELECT-MDS-1 Phase 3 trial of tamibarotene and azacitidine, with results anticipated in late 2024.
Syros is focused on developing tamibarotene, an oral RARα agonist, for treating hematologic malignancies, particularly higher-risk MDS with RARA gene overexpression.
