Medical College of Wisconsin, Milwaukee, WI 53226, USA.
Memorial Sloan Kettering Cancer Center, New York, NY 10021, USA.
Future Oncol. 2024;20(38):3065-3075. doi: 10.1080/14796694.2024.2402680. Epub 2024 Oct 10.
Up to 40% of newly diagnosed patients with chronic myeloid leukemia in chronic phase (CML-CP) discontinue treatment by 5 years, primarily due to resistance or intolerance. Rates of resistance to second-line (2L) treatment are also high. Some patients with resistance respond with dose escalation of tyrosine kinase inhibitors (TKIs). Asciminib demonstrated safety and efficacy across a broad dosage range. ASC2ESCALATE is an ongoing, Phase II, multicenter, single-arm, dose-escalation study of asciminib in 2L and first-line treatment of CML-CP. The primary end point is major molecular response at 12 months in 2L. Secondary end points include molecular responses at and by scheduled time points, survival, and safety. ASC2ESCALATE is the first study investigating asciminib in CML-CP following failure of one prior TKI. NCT05384587 (ClinicalTrials.gov).
高达 40%的慢性髓性白血病慢性期（CML-CP）初诊患者在 5 年内停止治疗，主要是由于耐药或不耐受。二线（2L）治疗的耐药率也很高。一些耐药患者对酪氨酸激酶抑制剂（TKI）进行剂量升级会有反应。Asciminib 在广泛的剂量范围内表现出安全性和疗效。ASC2ESCALATE 是一项正在进行的、二期、多中心、单臂、剂量递增研究，评估 asciminib 用于 2L 和 CML-CP 的一线治疗。主要终点是 2L 时 12 个月时的主要分子缓解。次要终点包括分子缓解和预定时间点的缓解、生存和安全性。ASC2ESCALATE 是在一项既往 TKI 治疗失败后首次研究 asciminib 在 CML-CP 中的应用。NCT05384587（ClinicalTrials.gov）。
