Syros Discontinues Mid-Stage Tamibarotene Program in Frontline Acute Myeloid Leukemia (AML)
Trial Discontinuation:
Syros Pharmaceuticals has discontinued enrollment in the SELECT-AML-1 Phase 2 clinical trial evaluating tamibarotene in combination with venetoclax and azacitidine for frontline AML treatment.
Futility Analysis:
The decision was based on a prespecified interim analysis showing similar complete response (CR)/complete response with incomplete hematologic recovery (CRi) rates in both the triplet and doublet arms, indicating a low probability of success.
Patient Data:
The analysis included data from 51 patients, with CR/CRi rates of 65% in the triplet arm and 70% in the doublet arm.
Stock Impact:
Following the announcement, Syros' stock plummeted by over 62% in premarket trading.
Ongoing Trials:
Despite this setback, Syros will continue to evaluate tamibarotene in combination with azacitidine in the SELECT-MDS-1 Phase 3 clinical trial for higher-risk myelodysplastic syndrome (MDS).
Tamibarotene:
Tamibarotene is an oral, selective retinoic acid receptor alpha (RARα) agonist, which has shown promise in previous trials for MDS.