Syros Pharmaceuticals' tamibarotene has failed to demonstrate efficacy in the Phase III SELECT-MDS-1 trial, a study evaluating its potential in myelodysplastic syndromes (MDS). The trial's outcome casts doubt on the future of the drug, particularly after a prior setback in acute myeloid leukemia (AML).
The SELECT-MDS-1 trial aimed to assess the efficacy and safety of tamibarotene in patients with RARA-positive myelodysplastic syndromes. However, the study did not meet its primary endpoint, leaving Syros to re-evaluate the path forward for the drug.
Analysts had anticipated that tamibarotene might offer a new treatment option for a subset of MDS patients, especially given the unmet need for targeted therapies in this heterogeneous group of hematologic disorders. The failure of SELECT-MDS-1 is a significant disappointment, as it suggests that the positive signals observed in earlier, smaller studies may not translate into clinically meaningful benefits for a broader MDS population.
The setback is compounded by a previous negative result for tamibarotene in acute myeloid leukemia. These consecutive failures raise questions about the drug's mechanism of action and its potential applicability across different hematologic malignancies. Syros Pharmaceuticals is now faced with the challenge of determining the future direction of its tamibarotene program, considering the implications of these recent trial results.
