Cancer-Focused Syros Pharmaceuticals Stops Mid-Stage Leukemia Combo Therapy Study, Cites Disappointing Unexpected Outcome
Cancer-Focused Syros Pharmaceuticals Stops Mid-Stage Leukemia Combo Therapy Study, Cites Disappointing Unexpected Outcome
Syros Pharmaceuticals Inc. (NASDAQ:SYRS) stock is trading lower on Tuesday after the company issued an update on the SELECT-AML-1 Phase 2 trial.
錫羅斯製藥公司（納斯達克股票代碼：SYRS）週二股價走低，此前該公司發佈了SELECT-AML-1第二階段試驗的最新情況。
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.
該公司宣佈，將停止註冊SELECT-AML-1 2期試驗，該試驗評估了他米巴羅汀與venetoclax和阿扎西替丁聯合治療的三聯療法，與venetoclax和阿扎替丁的雙聯療法相比，新診斷的、不適合的急性髓系白血病（AML）和RARA基因過度表達患者。
AbbVie Inc (NYSE:ABBV) and Roche Holdings AG (OTC:RHHBY) sell venetoclax as Venclexta. Bristol
艾伯維公司（紐約證券交易所代碼：ABBV）和羅氏控股股份公司（場外交易代碼：RHHBY）以Venclexta的名義出售venetoclax。布里斯托爾
Bristol Myers Squibb & Co (NYSE:BMY) markets azacitidine as Vidaza. This decision is based on the results of a prespecified interim analysis of the trial.
百時美施貴寶公司（紐約證券交易所代碼：BMY）以Vidaza的名義銷售阿扎胞苷。該決定基於預先規定的試驗中期分析的結果。
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.
8月9日對來自51名參加SELECT-AML-1的患者的數據進行了審查。該綜述包括在第40名隨機患者接受約三個月的研究藥物或停止治療後，對前40名隨機患者進行的預先規定的非約束性無效分析。
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%).
在三聯組（n=20；65％）和雙胞胎組（n=20；70％）中觀察到類似的完全反應（CR）/完全反應，血液學恢復不完全（CRi）率。
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.
因此，SELECT-AML-1研究在80名隨機患者的最終分析中成功顯示出優勢的可能性被認爲很低。
There were no new safety signals associated with the use of tamibarotene in combination with venetoclax and azacitidine.
沒有與他米巴羅汀與venetoclax和阿扎胞苷聯合使用相關的新的安全信號。
Patients currently enrolled in SELECT-AML-1 will have the opportunity to remain on the study at the discretion of study investigators.
目前註冊Select-AML-1的患者將有機會繼續參與該研究，由研究人員自行決定。
Syros plans to present data from SELECT-AML-1 at the Society of Hematologic Oncology Annual Meeting in September.
錫羅斯計劃在9月的血液腫瘤學會年會上公佈來自SELECT-AML-1的數據。
"We are disappointed by this unexpected outcome..." said David Roth, Chief Medical Officer of Syros.
錫羅斯首席醫療官戴維·羅斯說：「我們對這個意想不到的結果感到失望...」
"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.
羅斯補充說：「在我們之前的2期臨床試驗中，他米巴羅汀和阿扎胞苷的雙聯組合在新診斷的急性髓細胞白血病患者中爲RARA過度表達的急性髓細胞白血病患者提供了61％的CR/CRI率。」
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.
在針對新診斷的高危骨髓增生異常綜合徵患者的Select-MDS-1 3期試驗中，Syros繼續評估他米巴羅汀與阿扎胞苷的聯合用藥情況，該試驗適用於新診斷的RARA基因過度表達的較高風險骨髓增生異常綜合徵患者。
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.
SELECT-MDS-1試驗在2024年第一季度通過了預先規定的徒勞性分析。關鍵的企業責任數據預計將在2024年第四季度中期公佈。
Price Action: At last check on Tuesday, SYRS stock was down 60.50% to $1.98.
價格走勢：在週二的最後一次檢查中，SYRS股價下跌60.50％，至1.98美元。
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