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.
周二，Syros Pharmaceuticals Inc. (纳斯达克股票代码: SYRS) 股价下跌，因该公司发布了 SELECt-AML-1 二期试验的更新。
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.
该公司宣布，将停止招收新的患有急性髓系白血病 (AML) ，且 RARA 基因过度表达的新诊断，不适宜使用 azacitidine 和 venetoclax 的患者，参加 tamibarotene 三联疗法和 venetoclax + azacitidine 双联疗法的 SELECt-AML-1 二期试验。
AbbVie Inc (NYSE:ABBV) and Roche Holdings AG (OTC:RHHBY) sell venetoclax as Venclexta. Bristol
AbbVie Inc (纽交所股票代码: ABBV) 和 Roche Holdings AG (场外交易：RHHBY) 售卖 Venclexta 作为 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 (纽交所股票代码: BMY) 将 azacitidine 市场推向 Vidaza。该决定是基于试验的预定中期分析结果。
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.
于8月9日，审查了参与 SELECt-AML-1 的51名患者的数据。此次审查包括对前40名随机患者的先定非绑定无效分析，分析是在第40名随机患者接受了约三个月的研究药物或停止治疗之后进行的。
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%).
三联疗法 (n=20; 65%) 和双联疗法 (n=20; 70%) 所观察到的 CR/CRi (完全缓解/不完全造血恢复的完全缓解) 率类似。
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名随机患者的最终分析中展示出卓越优越性成功的概率被认为很低。
There were no new safety signals associated with the use of tamibarotene in combination with venetoclax and azacitidine.
使用 tamibarotene 与 venetoclax 和 azacitidine 无新的安全信号。
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 目前参加患者可以由研究人员酌情决定继续研究。
Syros plans to present data from SELECT-AML-1 at the Society of Hematologic Oncology Annual Meeting in September.
Syros 计划在九月份举行的血液肿瘤学年会上展示 SELECt-AML-1 的数据。
"We are disappointed by this unexpected outcome..." said David Roth, Chief Medical Officer of Syros.
Syros 首席医学官 David Roth 表示: "我们对这个意外的结果感到失望……"。
"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.
"在我们之前的二期临床试验中，tamibarotene 和 azacitidine 的双联疗法为新诊断 RARA 基因过度表达的 AML 患者提供了61%的 CR/CRi 率，"Roth 补充道。
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 持续在 SELECt-MDS-1 三期试验中评估 tamibarotene 和 azacitidine 的联用治疗，针对新诊断更高危的 RARA 基因过度表达的骨髓增生异常综合症患者。
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 试验通过了预定的无效分析。关键时刻的CR数据预计将会到 2024 年第四季度中旬。
Price Action: At last check on Tuesday, SYRS stock was down 60.50% to $1.98.
价格行情: 在周二的最后查询中，SYRS 股票下跌60.50%，至1.98美元。
- New Hospital Operator On The Block Ardent Health Garners Interest As Analysts Initiate With Bullish View.
- 新的医院运营商 Ardent Health 博得显着兴趣, 分析师看好该公司。