Syros(US:SYRS) ZACKS·2024-08-14 15:21Core Viewpoint - Syros Pharmaceuticals' shares dropped 61.7% after the company halted enrollment in the mid-stage acute myeloid leukemia (AML) study of tamibarotene due to poor interim analysis results [1][4]. Group 1: Study Details - The phase II SELECT-AML-1 study evaluated tamibarotene in combination with AbbVie's Venclexta and azacitidine against a doublet regimen of Venclexta and azacitidine in newly diagnosed, unfit AML patients with RARα gene overexpression [2]. - Data from 51 patients were analyzed, including a planned futility analysis of the first 40 randomized patients who had received approximately three months of treatment or had discontinued it [3]. - The study found similar complete response (CR) rates of 65% for the triplet therapy and 70% for the doublet therapy, leading to the conclusion that the likelihood of demonstrating superiority at the final analysis is low [4]. Group 2: Financial Impact - Year to date, Syros shares have declined 75.4%, while the industry has seen a 2.4% decline [4]. - Tamibarotene was reported to be well-tolerated, with no new safety signals identified, and patients already enrolled can opt to remain in the study [5]. Group 3: Future Focus - Following the discontinuation of the AML study, Syros will concentrate on the pivotal phase III SELECT-MDS-1 study, which is evaluating tamibarotene in combination with azacitidine compared to azacitidine monotherapy for higher-risk myelodysplastic syndrome patients [6]. - The SELECT-MDS-1 study has passed a prespecified futility analysis, and pivotal CR data is expected to be shared by mid-fourth quarter of 2024 [7]. Group 4: AbbVie and Venclexta - AbbVie's Venclexta generated revenues of $1.25 billion in the first half of 2024, reflecting a 16% growth driven by strong demand in AML and chronic lymphocytic leukemia (CLL) indications [9]. - AbbVie anticipates Venclexta's peak revenues to approach $5 billion, with ongoing studies to expand its label into other hematologic malignancies [8].