Asciminib demonstrates superior efficacy and safety in newly diagnosed chronic myeloid leukemia in the ASC4FIRST trial.

Treatments offering optimal efficacy, safety, and tolerability will support long-term therapy.

提供最佳疗效、安全性和耐受性的治疗将支持长期治疗

In the primary analysis from the ASC4FIRST trial, a phase 3 randomized trial comparing asciminib with investigator-selected TKIs (IS-TKIs) in newly diagnosed CML-CP, asciminib demonstrated superior efficacy vs all IS-TKIs and vs imatinib in the imatinib stratum, meeting both primary objectives.

在 ASC4FIRST 试验的初步分析中，这是一项比较阿西米尼布与研究者选择的酪氨酸激酶抑制剂（IS-TKIs）在新诊断的慢性髓性白血病慢性期（CML-CP）中的 III 期随机试验，阿西米尼布显示出比所有 IS-TKIs 和伊马替尼在伊马替尼层中更好的疗效，满足了两个主要目标。

In the secondary analysis (2.2 years' median follow-up), major molecular response (MMR) rate at week 96 was 74.1% with asciminib vs 52.0% with IS-TKIs (treatment difference, 22.4% [95% confidence interval(CI), 13.6-31.3]; 1-sided P< .001) and 76.2% with asciminib vs 47.1% with imatinib in the imatinib stratum (treatment difference, 29.7% [95% CI, 17.6-41.8]; 1-sided P< .001), meeting both key secondary objectives.

在次要分析中（中位随访时间为2.2年），在第96周时，阿西米尼布的主要分子反应（MMR）率为74.1%，而IS-TKIs为52.0%（治疗差异为22.4% [95%置信区间（CI），13.6-31.3]；单侧P< .001），阿西米尼布在伊马替尼层中的MMR率为76.2%，而伊马替尼为47.1%（治疗差异为29.7% [95% CI, 17.6-41.8]；单侧P< .001），满足了两个关键次要目标。

MMR rate was 72.0% with asciminib vs 56.9% with second-generation (2G) TKIs (treatment difference, 15.1% [95% CI, 2.3-28.0]; 1-sided P< .05), suggesting possible clinical benefit, although the study was not designed to formally confirm statistical significance for this secondary end point.

使用阿斯米尼布的MMR率为72.0%，与使用第二代酪氨酸激酶抑制剂（TKIs）的56.9%相比（治疗差异为15.1%，95%置信区间为2.3-28.0；单侧P<.05），这暗示了可能的临床益处，尽管该研究并未设计为正式确认这一次要终点的统计显著性。

Safety/tolerability remained favorable with asciminib vs IS-TKIs.

与IS-TKIs相比，阿斯米尼布的安全性和耐受性保持良好。

Dose reductions and interruptions, respectively, occurred with asciminib (18.5%; 46.5%), imatinib (23.2%; 47.5%), and 2G TKIs (54.9%; 63.7%).

剂量减少和中断分别发生在asciminib（18.5%；46.5%）、伊马替尼（23.2%；47.5%）和2G TKIs（54.9%；63.7%）中。

The hazard ratiofor time to discontinuation of treatment due to AEs for asciminib vs 2G TKIs was 0.46 (95% CI, 0.215-0.997).

由于不良事件导致治疗中断的asciminib与2G TKIs的时间风险比为0.46（95%置信区间，0.215-0.997）。

With longer follow-up, asciminib continued to demonstrate a favorable benefit-risk profile over IS-TKIs and imatinib, supporting its potential as a treatment option for newly diagnosed CML-CP.

随着更长时间的随访，asciminib继续显示出比IS-TKIs和伊马替尼更有利的效益-风险比，支持其作为新诊断的慢性髓性白血病慢性期（CML-CP）治疗选择的潜力。

This trial was registered at www.clinicaltrials.gov as NCT04971226.

这项试验已在www.clinicaltrials.gov上注册，注册号为NCT04971226。