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SELLAS Life Sciences Group, Inc. (SLS) announced the preliminary data from Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia and successful filing of a provisional patent application around the ASXL1 mutation and SLS009, including all CDK9 inhibitor drugs.
塞拉斯生命科学集团(SLS)宣布了SLS009(一种高选择性CDK9抑制剂)在复发/难治性急性髓细胞白血病中的2a期试验的初步数据,并成功提交了ASXL1突变和SLS009(包括所有CDK9抑制剂药物)的临时专利申请。
The company said, as of April 19, data cutoff, a 57% overall response rate has been achieved thus far, in the selected optimal dose regimen of 30 mg BIW, far surpassing the targeted 20% rate.SELLAS plans to initiate discussions with the FDA about the potential for an accelerated approval pathway with SLS009 in the ASXL1 molecularly defined r/r AML population as well as in patients harboring this mutation in other indications..
该公司表示,截至4月19日数据截止,迄今为止,在选定的30毫克白车身的最佳剂量方案中,总体缓解率达到了57%,远远超过了目标的20%。SELLAS计划与FDA开始讨论在ASXL1分子定义的r/r AML人群以及在其他适应症中携带这种突变的患者中,SLS009加速批准途径的可能性。。
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