Cancer-Focused Syros Pharmaceuticals Stops Mid-Stage Leukemia Combo Therapy Study, Cites Disappointing Unexpected Outcome

Syros Pharmaceuticals Inc. SYRS stock is trading lower on Tuesday after the company issued an update on the SELECT-AML-1 Phase 2 trial.

The company announced that it will discontinue enrollment in the SELECT-AML-1 Phase 2 trial evaluating the triplet regimen of tamibarotene in combination with venetoclax and azacitidine compared to the doublet regimen of venetoclax and azacitidine in newly diagnosed, unfit patients with acute myeloid leukemia (AML) and RARA gene overexpression.

AbbVie Inc ABBV and Roche Holdings AG RHHBY sell venetoclax as Venclexta. Bristol

Bristol Myers Squibb & Co BMY markets azacitidine as Vidaza. This decision is based on the results of a prespecified interim analysis of the trial.

Data from 51 patients enrolled in SELECT-AML-1 were reviewed on August 9. This review included a prespecified non-binding futility analysis conducted on the first 40 randomized patients after the fortieth randomized patient received approximately three months of study drug or discontinued treatment.

A similar complete response (CR)/complete response with incomplete hematologic recovery (CRi) rate was observed in the triplet arm (n=20; 65%) and the doublet arm (n=20; 70%).

As a result, the probability of the SELECT-AML-1 study’s success in demonstrating superiority in the final analysis of 80 randomized patients was considered low.

There were no new safety signals associated with the use of tamibarotene in combination with venetoclax and azacitidine.

Patients currently enrolled in SELECT-AML-1 will have the opportunity to remain on the study at the discretion of study investigators.

Syros plans to present data from SELECT-AML-1 at the Society of Hematologic Oncology Annual Meeting in September.

“We are disappointed by this unexpected outcome…” said David Roth, Chief Medical Officer of Syros.

“In our prior Phase 2 clinical trial, the doublet combination of tamibarotene and azacitidine delivered a 61% CR/CRi rate in newly diagnosed AML patients with RARA overexpression,” Roth added.

Syros continues to evaluate tamibarotene in combination with azacitidine in the SELECT-MDS-1 Phase 3 trial in newly diagnosed higher-risk myelodysplastic syndrome patients with RARA gene overexpression.

The SELECT-MDS-1 trial passed a prespecified futility analysis in the first quarter of 2024. Pivotal CR data are expected by the middle of the fourth quarter of 2024.

Price Action: At last check on Tuesday, SYRS stock was down 60.50% to $1.98.

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