On March 25, 2024 Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, reported that the enrollment of 190 patients has been completed in the SELECT-MDS-1 Phase 3 clinical trial evaluating tamibarotene in newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) patients with RARA gene overexpression (Press release, Syros Pharmaceuticals, MAR 25, 2024, View Source [SID1234641414]). This initial cohort of 190 patients is necessary to support the complete response (CR) primary endpoint analysis. Syros expects to report these pivotal data by the middle of the fourth quarter of 2024.
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"We are pleased to announce the completion of enrollment of the 190 patients necessary to support the primary CR endpoint in SELECT-MDS-1. This marks an important step in advancing tamibarotene through late-stage clinical development and brings us closer to delivering our RARα agonist as a frontline treatment option for the approximately 50 percent of HR-MDS patients with RARA overexpression," said David A. Roth, M.D., Chief Medical Officer of Syros. "We look forward to reporting pivotal data later this year which, if successful, will allow us to file our first New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and, ultimately, execute on our vision of fundamentally changing the standard of care in hematologic malignancies."
The Phase 3 SELECT-MDS-1 clinical trial is a double-blind, placebo-controlled study evaluating tamibarotene in newly diagnosed HR-MDS patients with RARA overexpression randomized 2:1 to receive tamibarotene in combination with azacitidine or azacitidine alone. The primary endpoint is CR rate in the first 190 patients enrolled in the trial which, together with supporting durability data, can serve as the basis for accelerated approval or full approval; the key secondary endpoint in SELECT-MDS-1 is overall survival (OS) in a total of 550 patients. This study design reflects an efficient "one-trial" approach and could allow SELECT-MDS-1 to serve as a confirmatory study, if needed, to convert from accelerated to full approval. Enrollment is ongoing to reach the 550-patient target.
Syros is also evaluating tamibarotene in combination with venetoclax and azacitidine in the SELECT-AML-1 Phase 2 clinical trial in newly diagnosed unfit acute myeloid leukemia patients with RARA gene overexpression. Syros previously reported initial data from the study, observing a 100% CR/CRi (complete response/complete response with incomplete hematologic recovery) rate in response-evaluable patients treated with the triplet regimen of tamibarotene, venetoclax and azacitidine without increased toxicity, as compared to 70% among patients treated with venetoclax and azacitidine alone. Syros expects to report additional data from SELECT-AML-1 in 2024. Read more here.