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.
週二，Syros Pharmaceuticals Inc. (納斯達克股票代碼: SYRS) 股價下跌，因該公司發佈了 SELECt-AML-1 二期試驗的更新。
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，將停止招收新的患有急性髓系白血病 (AML) ，且 RARA 基因過度表達的新診斷，不適宜使用 azacitidine 和 venetoclax 的患者，參加 tamibarotene 三聯療法和 venetoclax + azacitidine 雙聯療法的 SELECt-AML-1 二期試驗。
AbbVie Inc (NYSE:ABBV) and Roche Holdings AG (OTC:RHHBY) sell venetoclax as Venclexta. Bristol
AbbVie Inc (紐交所股票代碼: ABBV) 和 Roche Holdings AG (場外交易：RHHBY) 售賣 Venclexta 作爲 venetoclax，Bristol
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.
Bristol Myers Squibb & Co (紐交所股票代碼: BMY) 將 azacitidine 市場推向 Vidaza。該決定是基於試驗的預定中期分析結果。
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.
於8月9日，審查了參與 SELECt-AML-1 的51名患者的數據。此次審查包括對前40名隨機患者的先定非綁定無效分析，分析是在第40名隨機患者接受了約三個月的研究藥物或停止治療之後進行的。
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%).
三聯療法 (n=20; 65%) 和雙聯療法 (n=20; 70%) 所觀察到的 CR/CRi (完全緩解/不完全造血恢復的完全緩解) 率類似。
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，在80名隨機患者的最終分析中展示出卓越優越性成功的概率被認爲很低。
There were no new safety signals associated with the use of tamibarotene in combination with venetoclax and azacitidine.
使用 tamibarotene 與 venetoclax 和 azacitidine 無新的安全信號。
Patients currently enrolled in SELECT-AML-1 will have the opportunity to remain on the study at the discretion of study investigators.
SELECt-AML-1 目前參加患者可以由研究人員酌情決定繼續研究。
Syros plans to present data from SELECT-AML-1 at the Society of Hematologic Oncology Annual Meeting in September.
Syros 計劃在九月份舉行的血液腫瘤學年會上展示 SELECt-AML-1 的數據。
"We are disappointed by this unexpected outcome..." said David Roth, Chief Medical Officer of Syros.
Syros 首席醫學官 David Roth 表示: "我們對這個意外的結果感到失望……"。
"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.
"在我們之前的二期臨床試驗中，tamibarotene 和 azacitidine 的雙聯療法爲新診斷 RARA 基因過度表達的 AML 患者提供了61%的 CR/CRi 率，"Roth 補充道。
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.
Syros 持續在 SELECt-MDS-1 三期試驗中評估 tamibarotene 和 azacitidine 的聯用治療，針對新診斷更高危的 RARA 基因過度表達的骨髓增生異常綜合症患者。
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.
2024年第一季度，SELECt-MDS-1 試驗通過了預定的無效分析。關鍵時刻的CR數據預計將會到 2024 年第四季度中旬。
Price Action: At last check on Tuesday, SYRS stock was down 60.50% to $1.98.
價格行情: 在週二的最後查詢中，SYRS 股票下跌60.50%，至1.98美元。
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譯文內容由第三人軟體翻譯。
