Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, 8035, Spain.
Division of Medical Oncology, S.Orsola-Malpighi Hospital, University of Bologna, Bologna, 40138, Italy.
Eur J Cancer. 2020 Mar;127:160-172. doi: 10.1016/j.ejca.2019.11.019. Epub 2020 Feb 3.
CheckMate 171 (NCT02409368) is an open-label, multicentre, phase 2 trial of nivolumab in previously treated advanced squamous non-small cell lung cancer (NSCLC), conducted as part of a post-approval commitment to the European Medicines Agency (EMA). We report outcomes from this trial.
Patients with Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2 and disease progression during/after ≥1 systemic treatment (≥1 being platinum-based chemotherapy) for advanced or metastatic disease were treated with nivolumab 3 mg/kg every 2 weeks until progression or unacceptable toxicity. The primary end-point was incidence of grade 3-4 treatment-related select adverse events (AEs). Other end-points included overall survival (OS) and safety.
Of 811 patients treated, 103 had ECOG PS 2; 278 were aged ≥70 years and 125 were ≥75 years of age. Minimum follow-up was ~18 months. Safety was similar across populations; the most frequent grade 3-4 treatment-related select AEs in all treated patients were diarrhoea (1%), increased alanine aminotransferase (ALT, 1%), pneumonitis (0.7%), colitis (0.6%) and increased aspartate aminotransferase (AST, 0.5%). Median OS was similar in all treated patients and those aged ≥70 and ≥75: 10.0 months, 10.0 months and 11.2 months, respectively. Median OS was 5.2 months in patients with ECOG PS 2.
These results suggest that nivolumab is well tolerated and active in patients with advanced, relapsed squamous NSCLC, including the elderly, with OS outcomes consistent with phase 3 data. In patients with ECOG PS 2, nivolumab had similar tolerability, but outcomes were worse, as expected in this difficult-to-treat, poor prognosis population.
NCT02409368.
CheckMate 171（NCT02409368）是一项纳武利尤单抗治疗既往接受过治疗的晚期鳞状非小细胞肺癌（NSCLC）的开放性、多中心、2 期临床试验，作为向欧洲药品管理局（EMA）提交上市后承诺的一部分。我们报告了该试验的结果。
ECOG PS（东部肿瘤协作组体能状态）为 0-2 且在晚期或转移性疾病的治疗期间/之后经历了疾病进展，并且至少接受过 1 次（1 次以上）全身治疗（铂类化疗）的患者，接受纳武利尤单抗 3mg/kg，每 2 周 1 次，直至疾病进展或出现不可接受的毒性。主要终点是 3-4 级治疗相关选择不良事件（AE）的发生率。其他终点包括总生存期（OS）和安全性。
在 811 例接受治疗的患者中，有 103 例 ECOG PS 为 2；278 例患者年龄≥70 岁，125 例患者年龄≥75 岁。最小随访时间约为 18 个月。安全性在各人群中相似；所有治疗患者中最常见的 3-4 级治疗相关选择 AE 是腹泻（1%）、丙氨酸氨基转移酶（ALT）升高（1%）、肺炎（0.7%）、结肠炎（0.6%）和天冬氨酸氨基转移酶（AST）升高（0.5%）。所有治疗患者和年龄≥70 岁和≥75 岁的患者的中位 OS 相似：分别为 10.0 个月、10.0 个月和 11.2 个月。ECOG PS 为 2 的患者的中位 OS 为 5.2 个月。
这些结果表明，纳武利尤单抗在晚期、复发性鳞状 NSCLC 患者中耐受性良好且有效，包括老年人，OS 结果与 3 期数据一致。在 ECOG PS 为 2 的患者中，纳武利尤单抗的耐受性相似，但由于在这一难以治疗、预后不良的人群中预期会出现较差的结果，因此其疗效较差。
NCT02409368。
