CAMBRIDGE, Mass. - Syros Pharmaceuticals (NASDAQ:SYRS) has completed the enrollment of 190 patients for the SELECT-MDS-1 Phase 3 clinical trial, which is testing tamibarotene as a treatment for newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) with RARA gene overexpression.
The company announced Monday that this enrollment is a critical step towards their primary endpoint analysis of complete response (CR) rates. They anticipate reporting these pivotal trial results by mid-Q4 2024.
The SELECT-MDS-1 study is a double-blind, placebo-controlled trial, where patients are randomized 2:1 to receive either tamibarotene in combination with azacitidine or azacitidine alone. The primary focus of the trial is the CR rate in the first 190 patients.
If the data are supportive, they could potentially lead to accelerated or full approval of the drug. The trial also aims to enroll a total of 550 patients to assess overall survival (OS) as a key secondary endpoint.
David A. Roth, M.D., Chief Medical Officer of Syros, expressed optimism about the progress, stating that this development moves the company closer to offering tamibarotene as a frontline treatment option for HR-MDS patients exhibiting RARA overexpression, which accounts for approximately 50 percent of such patients. He also mentioned the company's goal of fundamentally changing the standard of care in hematologic malignancies.
In addition to SELECT-MDS-1, Syros is conducting the SELECT-AML-1 Phase 2 trial, evaluating tamibarotene in combination with venetoclax and azacitidine for the treatment of newly diagnosed unfit acute myeloid leukemia patients with RARA gene overexpression. Early data from this trial showed a 100% CR/CRi rate for the triplet regimen, with additional data expected to be reported in 2024.
Syros Pharmaceuticals is focused on developing treatments for patients with hematologic malignancies. Their approach is to target blood disorders with their oral selective RARα agonist, tamibarotene, for patients with HR-MDS and acute myeloid leukemia with RARA gene overexpression.
The information for this article is based on a press release statement from Syros Pharmaceuticals.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.