帕博利珠单抗对比伊匹木单抗治疗晚期黑色素瘤
Pembrolizumab versus Ipilimumab in Advanced Melanoma
当时免疫检查点抑制剂伊匹木单抗是晚期黑色素瘤的标准治疗。这项 3 期随机对照试验把 834 名晚期黑色素瘤患者按 1:1:1 分成三组，分别接受帕博利珠单抗每 2 周一次、每 3 周一次，或伊匹木单抗每 3 周一次共四剂。主要终点为无进展生存期和总生存期。结果显示，帕博利珠单抗两组的 6 个月无进展生存率分别为 47.3% 和 46.4%，伊匹木单抗组为 26.5%；12 个月生存率分别为 74.1%、68.4% 和 58.2%；缓解率分别为 33.7%、32.9% 和 11.9%。帕博利珠单抗两组 3–5 级治疗相关不良事件发生率（13.3% 和 10.1%）低于伊匹木单抗组（19.9%）。结论是抗 PD-1 抗体帕博利珠单抗较伊匹木单抗延长了无进展生存期和总生存期，且高级别毒性更少。
为什么推荐给您：PD-1 抗体头对头击败标准治疗，改变晚期黑色素瘤一线实践的大型随机试验。
不需要生物学背景，多打比方
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正常情况下，免疫T细胞能识别并攻击肿瘤细胞。
背景知识（不是原文内容）6个月无进展生存率：帕博利珠单抗每2周组47.3%，每3周组46.4%，伊匹木单抗组26.5%。
摘要Abstract
BACKGROUND: The immune checkpoint inhibitor ipilimumab is the standard-of-care treatment for patients with advanced melanoma. Pembrolizumab inhibits the programmed cell death 1 (PD-1) immune checkpoint and has antitumor activity in patients with advanced melanoma.
METHODS: In this randomized, controlled, phase 3 study, we assigned 834 patients with advanced melanoma in a 1:1:1 ratio to receive pembrolizumab (at a dose of 10 mg per kilogram of body weight) every 2 weeks or every 3 weeks or four doses of ipilimumab (at 3 mg per kilogram) every 3 weeks. Primary end points were progression-free and overall survival.
RESULTS: The estimated 6-month progression-free-survival rates were 47.3% for pembrolizumab every 2 weeks, 46.4% for pembrolizumab every 3 weeks, and 26.5% for ipilimumab (hazard ratio for disease progression, 0.58; P<0.001 for both pembrolizumab regimens versus ipilimumab; 95% confidence intervals [CIs], 0.46 to 0.72 and 0.47 to 0.72, respectively). Estimated 12-month survival rates were 74.1%, 68.4%, and 58.2%, respectively (hazard ratio for death for pembrolizumab every 2 weeks, 0.63; 95% CI, 0.47 to 0.83; P=0.0005; hazard ratio for pembrolizumab every 3 weeks, 0.69; 95% CI, 0.52 to 0.90; P=0.0036). The response rate was improved with pembrolizumab administered every 2 weeks (33.7%) and every 3 weeks (32.9%), as compared with ipilimumab (11.9%) (P<0.001 for both comparisons). Responses were ongoing in 89.4%, 96.7%, and 87.9% of patients, respectively, after a median follow-up of 7.9 months. Efficacy was similar in the two pembrolizumab groups. Rates of treatment-related adverse events of grade 3 to 5 severity were lower in the pembrolizumab groups (13.3% and 10.1%) than in the ipilimumab group (19.9%).
CONCLUSIONS: The anti-PD-1 antibody pembrolizumab prolonged progression-free survival and overall survival and had less high-grade toxicity than did ipilimumab in patients with advanced melanoma. (Funded by Merck Sharp & Dohme; KEYNOTE-006 ClinicalTrials.gov number, NCT01866319.).