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在前线的费城染色体阳性急性淋巴细胞白血病中Ponatinib与Imatinib:一项随机临床试验

Elias Jabbour¹, Hagop M Kantarjian¹, Ibrahim Aldoss²

¹The University of Texas MD Anderson Cancer Center, Houston.

|May 9, 2024

概括

与伊马替尼相比,波纳替尼在新诊断的费城染色体阳性急性淋巴细胞白血病 (Ph+ ALL) 中显著改善了MRD阴性完全缓解率. 安全性概况相似,为Ph+ ALL患者提供了新的前线选择.

科学领域:

血液学
癌症学
临床试验

背景情况:

新诊断的费城染色体阳性 (Ph+) 急性淋巴细胞白血病 (ALL) 中,获得的抗 BCR:: ABL1 激酶抑制剂是常见的挑战.
波纳替尼是对BCR:: ABL1及其变体 (包括T315I) 有效的强效抑制剂.

研究的目的:

在新诊断的Ph+ALL的成年患者中比较前线ponatinib的疗效和安全性.

主要方法:

一项全球性,第三阶段的开放性试验,随机选择了245名新诊断的Ph+ALL的成年人,接受波纳替尼 (30 mg/ d) 或意马替尼 (600 mg/ d) 与低强度化疗.
主要终点是诱导结束时MRD阴性完全缓解 (MR4),而无事件存活率是关键的次要终点.

主要成果:

与伊马替尼比 (16. 7%) 相比,波纳替尼的MRD阴性完全缓解率显著高 (P=. 002).
波纳替尼的中位数无事件生存期未达到,而伊马替尼的中位数为29个月.
不良事件在各组之间相似,动脉封闭事件不常见且相似.

结论:

在新诊断的Ph+ALL患者中,ponatinib与低强度化疗相结合时显示出较高的MRD阴性完全缓解率.
波纳替尼的安全性与伊马替尼相似,表明它是一个可行的第一线治疗方案.

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