施大爷祸不单行，CheckMate-451主要终点未达到

10月份nivolumab单药治疗二线SCLC临床噩耗，可以阅读先前推送：CheckMate-331未达到主要临床终点OS 。CheckMate-451前几日也宣布：其中nivo+ipi联合组在一线含铂化疗后无进展的ES-SCLC患者中对比安慰剂的维持治疗，没有达到主要临床终点OS。如果信息没有侧漏，现在还剩下单药组这个革命的火种，一口大锅若隐若现。

其它几家主流都是在一线含铂化疗±免疫治疗，而非上述的维持治疗，方案比较保守，但老罗已经成功，照着这个方案做成功几率还是蛮大的。

IMpower133的结果：Atezo+chemo vs chemo 一线ES-SCLC

  • ORR 60.2% vs 64.4%（其中CR 2.5%  vs 1.0%），DCR 81.1% vs 85.6%

  • 持续缓解时间：4.2 mos vs 3.9 mos，截止至data cut off日，分别14.9% vs 5.4%的患者仍在缓解

  • 整体上总生存12.3 mos vs 10.3 mos提升了2个月，HR 0.70, P=0.0069，一年生存率51.7% vs 38.2%

  • 无进展生存期5.2 mos vs 4.3 mos，HR 0.77, P=0.017，6个月无进展率30.9% vs 22.4%，一年无进展率12.8% vs 5.4%

  • 安全性事件方面：两组的血液毒性相似；atezo没有影响铂+依托泊苷；免疫相关不良事件与atezo单药组相近

剩下两家

另外前几日国内的抗PD-L1单抗SHR-1316开始招募一线ES-SCLC，也是在向成功先例致敬。

Bristol-Myers Squibb Announces CheckMate -451 Study Did Not Meet Primary Endpoint of Overall Survival with Opdivo Plus Yervoy Vs. Placebo as A Maintenance Therapy in Patients with Extensive-Stage Small Cell Lung Cancer After Completion of First-Line Chemotherapy

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced that the Phase 3 CheckMate -451 study did not meet its primary endpoint of overall survival (OS) with Opdivo (nivolumab) 1 mg/kg in combination with Yervoy(ipilimumab) 3 mg/kg versus placebo as a maintenance therapy for patients with extensive-stage small cell lung cancer (SCLC) without disease progression after completion of first-line platinum-based chemotherapy. No new safety signals were observed with Opdivo 1 mg/kg plus Yervoy 3 mg/kg in this study. The Company will work with study investigators on the future publication of these results.

About CheckMate -451

CheckMate -451 is a global, double-blind, randomized Phase 3 study evaluating Opdivo in combination with Yervoy and Opdivo monotherapy versus placebo as a maintenance therapy in patients with extensive-stage small cell lung cancer without disease progression after completion of first-line platinum-based chemotherapy. The primary endpoint of the study is overall survival (OS) with Opdivo plus Yervoy versus placebo. The secondary endpoint is OS with Opdivo monotherapy versus placebo.

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