We report the final analysis of the PROLONG study on ofatumumab maintenance in relapsed chronic lymphocytic leukemia (CLL). In all, 480 patients with CLL in complete or partial remission after second- or third-line treatment were randomized 1:1 to ofatumumab (300 mg first week, followed by 1000 mg every 8 weeks for up to 2 years) or observation. Median follow-up duration was 40.9 months. Median progression-free survival was 34.2 and 16.9 months for ofatumumab and observation arms, respectively, (hazard ratio, 0.55 [95% confidence interval, 0.43-0.70]; P < 0.0001). Median time to next treatment for ofatumumab and observation arms, respectively, was 37.4 and 27.6 months (0.72 [0.57-0.91]; P = 0.0044). Overall survival was similar in both arms; median was not reached (0.99 [0.72-1.37]). Grade ≥ 3 adverse events occurred in 62% and 51% of patients in ofatumumab and observation arms, respectively, the most common being neutropenia (23% and 10%), pneumonia (13% and 12%) and febrile neutropenia (6% and 4%). Up to 60 days after the last treatment, four deaths were reported in the ofatumumab arm versus six in the observation arm, none considered related to ofatumumab. Ofatumumab maintenance significantly prolonged progression-free survival in patients with relapsed CLL and was well tolerated.

中文翻译：

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Ofatumumab维持治疗可延长复发性慢性淋巴细胞白血病的无进展生存期：PROLONG研究的最终分析。

我们报告复发的慢性淋巴细胞性白血病（CLL）中ofatumumab维持的PROLONG研究的最终分析。总共将480例二线或三线治疗后完全缓解或部分缓解的CLL患者按1：1的比例随机分配至ofatumumab（第一周300 mg，随后每8周1000 mg，持续2年）或观察。中位随访时间为40.9个月。Ofatumumab和观察组的中位无进展生存期分别为34.2和16.9个月（危险比，0.55 [95％置信区间，0.43-0.70]； P <0.0001）。Ofatumumab和观察组下次治疗的中位时间分别为37.4和27.6个月（0.72 [0.57-0.91]； P = 0.0044）。两组的总生存率相似。中位数未达到（0.99 [0.72-1.37]）。在ofatumumab和观察组中，分别有62％和51％的患者发生≥3级不良事件，最常见的是中性粒细胞减少症（23％和10％），肺炎（13％和12％）和高热性中性粒细胞减少症（6％和6％）。 4％）。在最后一次治疗后的60天之内，ofatumumab组报告了4例死亡，而观察组报告了6例死亡，均无与OFatumumab相关的报道。Ofatumumab的维持显着延长了CLL复发患者的无进展生存期，并且耐受性良好。