Background

ATTRACTION-2 demonstrated that nivolumab improved overall survival (OS) vs placebo in patients with advanced gastric cancer treated with ≥ 2 chemotherapy regimens. However, its long-term efficacy and outcome of treatment beyond progression (TBP) with nivolumab have not been clarified.

Methods

The 3-year follow-up data were collected. A subset analysis was performed to explore the efficacy of TBP by assessing postprogression survival (PPS) after the first event of disease progression.

Results

Overall, 493 patients were randomized (2:1) to receive nivolumab (n = 330) or placebo (n = 163). With a median follow-up of 38.5 (range 36.1–47.5) months, OS of the nivolumab group was significantly longer compared to the placebo group (median 5.3 vs 4.1 months; 3-year survival rate, 5.6% vs 1.9%; hazard ratio [HR], 0.62 [95% confidence interval (CI) 0.50–0.75], P < 0.0001). The median OS of responders (n = 32) who achieved complete response or partial response was 26.7 months and the 3-year survival rate was 35.5% in the nivolumab group. Overall, 109 patients in the nivolumab group and 37 patients in the placebo group received TBP. PPS tended to be longer in the nivolumab group vs placebo group (median 5.8 vs 4.5 months; HR [95% CI], 0.69 [0.47–1.01], P = 0.057). In contrast, PPS was similar between both treatment groups in non-TBP patients (median 2.3 vs 2.2 months; HR 0.90, P = 0.42).

Conclusions

Long-term efficacy of nivolumab was confirmed at the 3-year follow-up, and a survival benefit of TBP with nivolumab was suggested. Biomarkers for selecting patients suitable for TBP with nivolumab should be identified in the future.

中文翻译：

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既往接受过治疗的晚期胃癌中的纳武单抗 (ATTRACTION-2)：3 年更新和纳武单抗进展后的治疗结果

背景

ATTRACTION-2 表明，在接受 ≥ 2 种化疗方案治疗的晚期胃癌患者中，纳武单抗与安慰剂相比提高了总生存期 (OS)。然而，其长期疗效和 nivolumab 治疗超越进展 (TBP) 的结果尚未阐明。

方法

收集了 3 年的随访数据。进行子集分析以通过评估疾病进展的第一次事件后的进展后生存 (PPS) 来探索 TBP 的功效。

结果

总体而言，493 名患者随机 (2:1) 接受纳武单抗 ( n  = 330) 或安慰剂 ( n  = 163)。中位随访时间为 38.5（36.1-47.5）个月，纳武单抗组的 OS 显着长于安慰剂组（中位 5.3 与 4.1 个月；3 年生存率，5.6% 与 1.9%；风险比） [HR]，0.62 [95% 置信区间 (CI) 0.50–0.75]，P  < 0.0001）。响应者的中位 OS ( n = 32) 达到完全缓解或部分缓解的患者为 26.7 个月，纳武单抗组的 3 年生存率为 35.5%。总体而言，纳武单抗组 109 名患者和安慰剂组 37 名患者接受了 TBP。与安慰剂组相比，纳武单抗组的 PPS 往往更长（中位 5.8 个月与 4.5 个月；HR [95% CI]，0.69 [0.47–1.01]，P  = 0.057）。相比之下，非 TBP 患者的两个治疗组之间的 PPS 相似（中位 2.3 个月与 2.2 个月；HR 0.90，P  = 0.42）。

结论

nivolumab 的长期疗效在 3 年的随访中得到证实，并建议 TBP 与 nivolumab 的生存获益。未来应确定用于选择适合纳武单抗 TBP 患者的生物标志物。