The Complement 1 trial investigated the efficacy and safety of ofatumumab + chlorambucil with chlorambucil monotherapy in patients with previously untreated chronic lymphocytic leukaemia (CLL). On long‐term follow‐up in the chemoimmunotherapy arm vs. the chemotherapy arm there was an estimated 12% (not significant) and 39% risk reduction in overall survival and progression‐free survival, respectively. A high rate (61%) of treatment with next‐line therapies in both the treatment arms may dilute any potential OS difference and confound the interpretation of the OS results. Addition of ofatumumab to chlorambucil demonstrated clinical benefit and tolerability as a frontline treatment option in patients unfit for fludarabine‐containing therapy, with no new safety concerns.

中文翻译：

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对非特发单抗和苯丁酸氮芥治疗的慢性淋巴细胞性白血病未经治疗的患者进行了为期五年的随访：对补体1 3期试验的最终分析。

补体1试验研究了ofatumumab +苯丁酸氮芥联合苯丁酸氮芥单药治疗先前未治疗的慢性淋巴细胞性白血病（CLL）的疗效和安全性。在化学免疫治疗组和化学治疗组的长期随访中，总体生存率和无进展生存率估计分别降低了12％（不显着）和39％。两个治疗分支中采用下一线疗法进行的高治疗率（61％）可能会稀释任何潜在的OS差异，并混淆OS结果的解释。在苯丁酸氮芥中加用ofatumumab证明，对于不适合使用氟达拉滨治疗的患者，作为一线治疗选择，其临床益处和耐受性无新的安全隐患。