First-line ibrutinib plus venetoclax for nonblastoid mantle cell lymphoma in patients ≥65 years old or with TP53 mutations.

Eligible patients received oral ibrutinib 560 mg once daily and venetoclax (5-week ramp-up to 400 mg once daily) for 2 years, then single-agent ibrutinib 560 mg until disease progression or unacceptable toxicity.

符合条件的患者接受口服伊布替尼560 mg每日一次和维奈妥昔单抗（5周逐渐增加至每日400 mg）治疗2年，然后单药伊布替尼560 mg直至疾病进展或无法接受的毒性。

In total, 78 patients were enrolled.

共有78名患者被纳入研究。

With a median time on study of 40.5 months, the complete response (CR) rate was 69% (95% confidence interval[CI], 58-79), and the overall response rate was 95% (95% CI, 87-99).

在中位随访时间为40.5个月的情况下，完全缓解（CR）率为69%（95%置信区间[CI]，58-79），总缓解率为95%（95% CI，87-99）。

The median duration of response was 37.1 months (95% CI, 30.3 to not estimable [NE]).

反应持续时间的中位数为37.1个月（95% CI，30.3至无法估计[NE]）。

The median progression-free survival(mPFS) was 40.2 months (95% CI, 29.4 to NE); median overall survival(OS) was not reached (3-year OS rate, 79% [95% CI, 68-86]).

无进展生存期（mPFS）的中位数为40.2个月（95% CI，29.4至NE）；总生存期（OS）的中位数未达到（3年OS率为79% [95% CI，68-86]）。

In patients aged ≥65 years, CR rates were 76% (no TP53m) and 44% (with TP53m), mPFS was 40.2 and 22.0 months, and 3-year OS was 85% and 66%, respectively.

在年龄≥65岁的患者中，CR率分别为76%（无TP53m）和44%（有TP53m），mPFS分别为40.2个月和22.0个月，3年OS分别为85%和66%。

In adult patients aged <65 years (with TP53m), the CR rate was 73%, mPFS was 15.4 months, and 3-year OS was 73%.

在年龄<65岁的成年患者中（有TP53m），CR率为73%，mPFS为15.4个月，3年OS为73%。

The most common treatment-emergent adverse events were diarrhea (49%), fatigue (37%), neutropenia (35%), and COVID-19 (32%).

最常见的治疗相关不良事件是腹泻（49%），疲劳（37%），中性粒细胞减少症（35%）和COVID-19（32%）。

First-line ibrutinib plus venetoclax showed promising efficacy, with high CR rates and durable remissions, in patients with previously untreated nonblastoid MCL and may be an option for patients aged ≥65 years or patients of any age with TP53m.

一线伊布替尼联合维奈克拉在之前未接受治疗的非blastoid型套细胞淋巴瘤患者中显示出有希望的疗效，具有高完全缓解率和持久的缓解，可能是≥65岁患者或任何年龄的TP53突变患者的治疗选择。

The trial was registered at www.clinicaltrials.gov as NCT03112174.

该试验已在www.clinicaltrials.gov注册，注册号为NCT03112174。