Introduction: Cohort G of KEYNOTE‐021 (NCT02039674) evaluated the efficacy and safety of pembrolizumab plus pemetrexed‐carboplatin (PC) versus PC alone as first‐line therapy for advanced nonsquamous NSCLC. At the primary analysis (median follow‐up time 10.6 months), pembrolizumab significantly improved objective response rate (ORR) and progression‐free survival (PFS); the hazard ratio (HR) for overall survival (OS) was 0.90 (95% confidence interval [CI]: 0.42‐1.91). Herein, we present an updated analysis. Methods: A total of 123 patients with previously untreated stage IIIB/IV nonsquamous NSCLC without EGFR and/or ALK receptor tyrosine kinase gene (ALK) aberrations were randomized 1:1 to four cycles of PC with or without pembrolizumab, 200 mg every 3 weeks. Pembrolizumab treatment continued for 2 years; maintenance pemetrexed was permitted in both groups. Eligible patients in the PC‐alone group with radiologic progression could cross over to pembrolizumab monotherapy. p Values are nominal (one‐sided p < 0.025). Results: As of December 1, 2017, the median follow‐up time was 23.9 months. The ORR was 56.7% with pembrolizumab plus PC versus 30.2% with PC alone (estimated difference 26.4% [95% CI: 8.9%‐42.4%, p = 0.0016]). PFS was significantly improved with pembrolizumab plus PC versus PC alone (HR = 0.53, 95% CI: 0.33‐0.86, p = 0.0049). A total of 41 patients in the PC‐alone group received subsequent anti‐programmed death 1/anti‐programmed death ligand 1 therapy. The HR for OS was 0.56 (95% CI: 0.32‐0.95, p = 0.0151). Forty‐one percent of patients in the pembrolizumab plus PC group and 27% in the PC‐alone group had grade 3 to 5 treatment‐related adverse events. Conclusions: The significant improvements in PFS and ORR with pembrolizumab plus PC versus PC alone observed in the primary analysis were maintained, and the HR for OS with a 24‐month median follow‐up was 0.56, favoring pembrolizumab plus PC.

中文翻译：

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KEYNOTE-021 队列 G 的 24 个月总生存期：培美曲塞和卡铂联合或不联合派姆单抗作为晚期非鳞状非小细胞肺癌的一线治疗

简介：KEYNOTE-021 队列 G (NCT02039674) 评估了派姆单抗联合培美曲塞卡铂 (PC) 与单独 PC 作为晚期非鳞状 NSCLC 一线治疗的疗效和安全性。在主要分析中（中位随访时间 10.6 个月），派姆单抗显着提高了客观缓解率（ORR）和无进展生存期（PFS）；总生存期 (OS) 的风险比 (HR) 为 0.90（95% 置信区间 [CI]：0.42-1.91）。在此，我们提供更新的分析。方法：共有 123 名既往未经治疗且无 EGFR 和/或 ALK 受体酪氨酸激酶基因 (ALK) 畸变的 IIIB/IV 期非鳞状 NSCLC 患者按 1:1 随机分配至 4 个周期的 PC 联合或不联合帕博利珠单抗，每 3 周 200 mg . 派姆单抗治疗持续 2 年；两组均允许维持培美曲塞。有放射学进展的单独 PC 组中符合条件的患者可以交叉使用 pembrolizumab 单药治疗。p 值是名义上的（单侧 p < 0.025）。结果：截至2017年12月1日，中位随访时间为23.9个月。帕博利珠单抗加 PC 的 ORR 为 56.7%，而单独 PC 的 ORR 为 30.2%（估计差异为 26.4% [95% CI：8.9%-42.4%，p = 0.0016]）。与单独使用 PC 相比，派姆单抗加 PC 的 PFS 显着改善（HR = 0.53，95% CI：0.33-0.86，p = 0.0049）。单独 PC 组共有 41 名患者接受了随后的抗程序性死亡 1/抗程序性死亡配体 1 治疗。OS 的 HR 为 0.56（95% CI：0.32-0.95，p = 0.0151）。帕博利珠单抗加 PC 组 41% 和单独 PC 组 27% 的患者出现 3 至 5 级治疗相关不良事件。结论：在主要分析中观察到的 pembrolizumab 加 PC 与单独 PC 相比，PFS 和 ORR 的显着改善得以维持，24 个月中位随访的 OS 的 HR 为 0.56，有利于派姆单抗加 PC。