Acalabrutinib-obinutuzumab improves survival vs chemoimmunotherapy in treatment-naive CLL in the 6-year follow-up of ELEVATE-TN.

We present results from ELEVATE-TN after a median follow-up of 74.5 months.

在中位随访74.5个月后，我们展示了ELEVATE-TN研究的结果。

Overall, 535 patients were randomized (acalabrutinib-obinutuzumab, n = 179; acalabrutinib, n = 179; chlorambucil-obinutuzumab, n = 177).

总体而言，535名患者被随机分配（acalabrutinib-obinutuzumab组，n = 179；acalabrutinib组，n = 179；chlorambucil-obinutuzumab组，n = 177）。

Median age was 70 years, 63.0% had unmutated immunoglobulin heavy chain variable region gene (uIGHV), 13.6% had del(17p) and/or mutated TP53, and 17% had complex karyotype (CK; ≥3 chromosomal abnormalities).

中位年龄为70岁，63.0%的患者具有未突变的免疫球蛋白重链可变区基因（uIGHV），13.6%的患者具有del(17p)和/或突变的TP53，17%的患者具有复杂核型（CK；≥3种染色体异常）。

Median progression-free survival(PFS) was not reached (NR) for acalabrutinib-obinutuzumab and acalabrutinib vs 27.8 months for chlorambucil-obinutuzumab (both P < .0001); estimated 72-month overall PFS rates were 78.0%, 61.5%, and 17.2%, respectively.

中位无进展生存期（PFS）对于阿卡布替尼-奥布替尼和阿卡布替尼组未达到（NR），而对于氯氨比林-奥布替尼组为27.8个月（两者P < .0001）；估计的72个月总体PFS率分别为78.0%，61.5%和17.2%。

Acalabrutinib-obinutuzumab resulted in improved PFS vs acalabrutinib monotherapy (hazard ratio[HR], 0.58; P = .0229).

阿卡布替尼-奥布替尼相较于阿卡布替尼单药治疗改善了PFS（风险比[HR]，0.58；P = .0229）。

Patients with uIGHV, del(17p) and/or mutated TP53, or CK had significantly improved PFS with acalabrutinib ± obinutuzumab vs chlorambucil-obinutuzumab (P < .0001, P ≤ .0009, and P < .0001 for both acalabrutinib-containing arms, respectively).

具有uIGHV、del(17p)和/或TP53突变或CK的患者，使用acalabrutinib ± obinutuzumab与氯氨比林-obinutuzumab相比，显著改善了无进展生存期(PFS) (P < .0001, P ≤ .0009, 和 P < .0001分别对应两种含acalabrutinib的治疗方案)。

Median overall survival(OS) was NR for all treatments, with significantly longer OS for acalabrutinib-obinutuzumab than chlorambucil-obinutuzumab (HR, 0.62; P = .0349).

所有治疗的中位总生存期(OS)均为未达到(NR)，但acalabrutinib-obinutuzumab的总生存期显著长于氯氨比林-obinutuzumab (HR, 0.62; P = .0349)。

Estimated 72-month OS rates were 83.9%, 75.5%, and 74.7% for acalabrutinib-obinutuzumab, acalabrutinib, and chlorambucil-obinutuzumab, respectively.

估计的72个月总生存率分别为83.9%、75.5%和74.7%，分别对应于acalabrutinib-obinutuzumab、acalabrutinib和chlorambucil-obinutuzumab治疗组。

Adverse events (AEs) occurring after >4 years were mostly grade 1 to 2.

在超过4年的时间里发生的不良事件（AEs）大多为1到2级。

Rates of AEs, serious AEs, and events of clinical interest were similar between acalabrutinib-containing arms and consistent with the known safety profiles of acalabrutinib and obinutuzumab.

含阿卡布替尼的治疗组不良事件(AEs)、严重不良事件(SAEs)和临床关注事件的发生率与阿卡布替尼和奥布珠单抗已知的安全性特征相似。

Efficacy and safety of acalabrutinib-containing arms were maintained, with longer PFS in both acalabrutinib arms than chlorambucil-obinutuzumab including in patients with high-risk features.

含阿卡布替尼的治疗组的疗效和安全性得到维持，在两个含阿卡布替尼的治疗组中，无进展生存期(PFS)较氯氨比林-奥布珠单抗组更长，这在具有高危特征的患者中同样成立。

This trial was registered at www.ClinicalTrials.gov as #NCT02475681.

该试验已在www.ClinicalTrials.gov注册，注册号为#NCT02475681。