Syros Pharmaceuticals announced that updated clinical data from its ongoing Phase 2 trial evaluating SY-1425, its first-in-class selective retinoic acid receptor alpha (RARa) agonist, in combination with azacitidine, continue to demonstrate high complete response rates, rapid onset of action and a favorable tolerability profile in a genomically defined subset of newly diagnosed acute myeloid leukemia (AML) patients who are not suitable candidates for standard intensive chemotherapy. These data are being presented at the European School of Haematology (ESH) 5th International Conference Acute Myeloid Leukemia “Molecular and Translational”: Advances in Biology and Treatment in Estoril, Portugal. Updated Clinical Data on SY-1425 in Combination with Azacitidine in Newly Diagnosed, Unfit AML Patients: Syros presented updated data from its Phase 2 trial of SY-1425 in combination with azacitidine, a standard-of-care hypomethylating agent, in newly diagnosed unfit AML patients. The trial evaluated the safety and efficacy of the combination in patients with either the RARA or IRF8 biomarker, as well as in patients without the biomarkers. All patients were treated with azacitidine administered at standard daily doses of 75 mg/m2 intravenously or subcutaneously for seven days, followed by SY-1425 administered at 6 mg/m2/day orally, divided in two doses, for the remainder of each 28-day cycle. As of Aug. 22, 2019, 40 newly diagnosed unfit AML patients had been enrolled in the trial and were eligible for the safety analysis. The median age of patients enrolled in the study was 76. Of the 17 biomarker-positive patients evaluable for response, 13 were RARA-positive and four were IRF8-positive. Enrollment in the newly diagnosed unfit cohorts of the ongoing Phase 2 trial is nearly complete. Syros will continue to follow patients enrolled in the trial to further characterize the overall profile of the combination, including safety, efficacy and durability of response.