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Syros Pharmaceuticals presents safety lead-in data from SELECT-AML-1 trial
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Syros Pharmaceuticals presents safety lead-in data from SELECT-AML-1 trial

Syros Pharmaceuticals announced data from the safety lead-in portion of its ongoing SELECT-AML-1 Phase 2 trial evaluating tamibarotene, an oral, selective retinoic acid receptor alpha agonist, in combination with venetoclax and azacitidine in newly diagnosed, unfit patients with acute myeloid leukemia and RARA gene overexpression. As of October 13, 2022, eight newly diagnosed, unfit, RARA-positive patients had been enrolled in the trial, including six who were evaluable for response. The median age of the patients was 61 and the median percent blasts at baseline was 63%. Tamibarotene in combination with venetoclax and azacitidine administered at approved doses showed no evidence of increased toxicity relative to the doublet combination of venetoclax and azacitidine. This includes rates of myelosuppression, which were comparable to reports with venetoclax and azacitidine in this population. Serious adverse events were reported in all six patients. The majority of non-hematologic AEs were low grade and reversible. The complete response and complete response with incomplete blood count recovery rate, as defined by Revised International Working Group criteria was 83%, consisting of two patients who achieved a CR and three patients who achieved a CRi. Four of five patients who achieved a CR or CRi had a high monocytic expression score, which may be associated with venetoclax resistance. Median time to CR/CRi response was 33 days. Median duration of treatment was 76.5 days and median duration of follow-up was 107 days. These early data compare favorably to the standard-of-care combination of venetoclax and azacitidine, which shows composite CR rates of 66% in newly diagnosed unfit AML patients. Based on the data, Syros plans to advance into the randomized portion of the SELECT-AML-1 Phase 2 trial, which will evaluate the safety and efficacy of tamibarotene in combination with venetoclax and azacitidine in approximately 80 patients positive for RARA overexpression randomized 1:1 to treatment with tamibarotene and venetoclax/azacitidine vs. venetoclax/azacitidine. The trial will incorporate venetoclax dose modification guidelines based on the recently published European LeukemiaNet recommendations,3 and will also evaluate the triplet regimen as a salvage therapy in patients who do not respond to venetoclax and azacitidine in the control arm. The randomized portion is expected to initiate in Q1 2023, with data expected in 2023 or 2024.

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