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Syros Pharmaceuticals Inc (NASDAQ:SYRS) revealed on Tuesday that the SELECT-MDS-1 Phase 3 trial of tamibarotene did not meet its primary endpoint of complete response rate.
The trial assessed tamibarotene in combination with azacitidine in newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) patients with RARA gene overexpression.
Myelodysplastic syndrome is a rare blood cancer that occurs when the DNA in bone marrow stem cells is damaged, preventing them from producing healthy blood cells.
In the first 190 enrolled patients, the complete response rate by intent-to-treat (ITT) in the tamibarotene/azacitidine treatment arm was 23.8% compared to 18.8% in the placebo/azacitidine control arm and was not statistically significant (p-value = 0.2084).
Bristol Myers Squibb & Co (NYSE:BMY) markets azacitidine as Vidaza.
In the safety analysis of all enrolled patients (n=245), tamibarotene combined with azacitidine (n=160) appeared to be generally well-tolerated, with an adverse event profile similar to that seen in earlier Syros-sponsored studies.
Syros also reported, as previously disclosed in its filings with the U.S. Securities and Exchange Commission (SEC), the failure of the SELECT-MDS-1 trial to achieve its primary endpoint constitutes an event of default under its secured loan facility with Oxford Finance.
“We are deeply disappointed by this outcome, particularly for the HR-MDS patients who are seeking a new treatment option for this challenging disease,” said Conley Chee, CEO of Syros. “We plan to stop the study, review the clinical data more thoroughly and evaluate the next steps.”
In August, Syros Pharmaceuticals discontinued enrollment in the SELECT-AML-1 Phase 2 trial, which evaluated a triplet regimen of tamibarotene in combination with venetoclax and azacitidine compared to a doublet regimen of venetoclax and azacitidine in newly diagnosed, unfit patients with acute myeloid leukemia (AML) and RARA gene overexpression.
The company said the probability of the SELECT-AML-1 study’s success in demonstrating superiority in the final analysis of 80 randomized patients was considered low.
SYRS Price Action: SYRS stock is down 86.43% at 37 cents at last check Wednesday.
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