Syros Pharmaceuticals (SYRS) announced Wednesday positive initial data from its ongoing SELECT-AML-1 Phase 2 trial evaluating tamibarotene, in combination with venetoclax and azacitidine in newly diagnosed, unfit patients with acute myeloid leukemia or AML and RARA gene overexpression.
In pre-market activity on Nasdaq, the shares were gaining around 10 percent to trade at $3.09.
Tamibarotene is an oral, selective, retinoic acid receptor alpha or RAR agonist. Syros continues to enroll patients in SELECT-AML-1 and anticipates reporting updated data from the trial in 2024.
The company noted that SELECT-AML-1 is evaluating the safety and efficacy of tamibarotene in combination with venetoclax and azacitidine compared to venetoclax and azacitidine in approximately 80 patients randomized 1:1.
The trial is also evaluating the triplet regimen as a salvage strategy in patients in the control arm who do not respond to venetoclax and azacitidine. The primary endpoint of the trial is complete response rateor CR /complete response with incomplete hematologic recovery or Cri.
In December 2022, Syros reported data from the safety lead-in portion of SELECT-AML-1, in which five of six response evaluable patients achieved CR/CRi.
Thomas Cluzeau, Head of Hematology at Nice University Hospital, Cte d’Azur University in France, said, “Despite the recent advances in treatment for unfit AML patients, there remains a substantial need for options that offer higher response rates and improved overall survival, particularly for the one-third of patients who do not respond to existing standard-of-care. I believe tamibarotene may offer a significant therapeutic advance for the treatment of AML and I am eager to continue enrolling patients in the ongoing SELECT-AML-1 trial.”
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