FDA 批准纳武利尤单抗联合含铂两药化疗用于早期非小细胞肺癌（NSCLC）的新辅助治疗环节

摘要：FDA 批准纳武利尤单抗联合含铂两药化疗用于早期非小细胞肺癌（NSCLC）的新辅助治疗环节

FDA 批准纳武利尤单抗联合含铂两药化疗用于早期非小细胞肺癌（NSCLC）的新辅助治疗环节

【1】2022 年 3 月 4 日，美国食品药品监督管理局 (FDA) 批准了纳武利尤单抗(Opdivo, Bristol-Myers Squibb Company) 联合含铂两药化疗用于可切除的非小细胞肺癌 (NSCLC) 成年患者的新辅助治疗。

【2】这是 FDA 首次批准用于早期 NSCLC 的新辅助治疗。

【3】在 CHECKMATE-816 (NCT02998528) 中评估了疗效，这是一项随机、开放标签研究，对象为可切除、组织学证实的 IB 期（≥4 cm）、II 或 IIIA 期 NSCLC（AJCC/UICC 分期标准）和可测量疾病（RECIST v1 .1.)。无论肿瘤 PD-L1 状态如何，患者都被纳入。共有358名患者被随机分为两组，一组接受纳武利尤单抗+含铂两药化疗，每3周一次，最多3个周期，另一组接受化疗，疗程相同。

【4】 通过盲法独立中心评价，主要疗效指标为无事件生存率（EFS）和病理完全反应（pCR）。

【5】纳武利尤单抗+化疗组的中位EFS为31.6个月（95%可信区间[CI]30.2，未达到），而单独接受化疗组的中位EFS为20.8个月（95%可信区间14.0，26.7）。危险比为0.63（97.38%可信区间0.43,0.91；p=0.0052）。纳武利尤单抗+化疗组的pCR率为24%（95%可信区间18.0,31.0），单纯化疗组的pCR率为2.2%（95%可信区间0.6,5.6）。

【6】 最常见的不良反应（发生率）≥20%的患者出现恶心、便秘、疲劳、食欲下降和皮疹。

【7】 在化疗中加入纳武利尤单抗并没有导致更频繁的延迟或取消手术。在研究的两组患者中，最终手术后中位住院时间和被确定为手术并发症的不良反应发生率相似。

【8】 建议的纳武利尤单抗剂量为360mg，每3周一次，在同一天使用含铂两药化疗，共3个周期。

原文

【1】On 4 March 2022, the US Food and Drug Administration (FDA) approved nivolumab (Opdivo, Bristol-Myers Squibb Company) with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting.

【2】This represents the first FDA approval for neoadjuvant therapy for early-stage NSCLC.

 【3】Efficacy was evaluated in CHECKMATE-816 (NCT02998528), a randomised, open label study in patients with resectable, histologically confirmed Stage IB (≥4 cm), II, or IIIA NSCLC (AJCC/UICC staging criteria) and measurable disease (RECIST v1.1.). Patients were enroled regardless of the tumour PD-L1 status. A total of 358 patients were randomised to receive either nivolumab plus platinum-doublet chemotherapy administered every 3 weeks for up to 3 cycles, or platinum-chemotherapy alone administered on the same schedule.

【4】The main efficacy outcome measures were event-free survival (EFS) and pathologic complete response (pCR) by blinded independent central review.

 【5】Median EFS was 31.6 months (95% confidence interval [CI] 30.2, not reached) in the nivolumab plus chemotherapy arm and 20.8 months (95% CI 14.0, 26.7) for those receiving chemotherapy alone. The hazard ratio was 0.63 (97.38% CI 0.43, 0.91; p = 0.0052). The pCR rate was 24% (95% CI 18.0, 31.0) in the nivolumab plus chemotherapy arm and 2.2% (95% CI 0.6, 5.6) in the chemotherapy alone arm.

 【6】The most common adverse reactions (incidence ≥20%) occurring in patients were nausea, constipation, fatigue, decreased appetite, and rash.

【7】The addition of nivolumab to chemotherapy did not result in more frequent delays or cancellations of surgery. The median lengths of hospital stays following definitive surgery and the rates of adverse reactions identified as surgical complications were similar for patients in both arms of the study.

 【8】The recommended nivolumab dose is 360 mg with platinum-doublet chemotherapy on the same day every 3 weeks for 3 cycles.