ESMO-IO19 & SABCS19 Day3
先是CM227 Part 2的最终分析
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在设计无比奇葩的CM227的Part1b里,相比化疗,Nivo联合化疗在PD-L1<1%的NSCLC中证明了clinical meaningful的疗效优势:OS HR 0.78,1年OSR 59% vs 51% ,2年OSR 35% vs 23%
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研究设计:入组IV期或复发的患者,主要终点非鳞患者的OS
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统计假设
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患者基线“基本”平衡,其中PD-L1阴性40%,阳性50%,高表达占20-25%
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化疗组后续30%接受免疫治疗
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主要终点非鳞患者中的OS:Nivo联合化疗相比化疗降低了14%的死亡风险,OS在数值上有着获益的趋势:18.8 vs 15.6mo,但没有满足HR 0.69的预设值,P值也没有统计学差异【KN189 OS HR 0.49】
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次要终点所有受试者的OS 18.3 vs 14.7mo,死亡风险降低19%;
而鳞癌患者的OS 18.3 vs 12.0mo,死亡风险降低31%【KN407 OS HR 0.64】
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亚组分析:NIVO联合化疗未给部分亚组带来OS获益
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非鳞患者的PFS 8.7 vs 5.8mo 疾病进展或死亡风险降低33%
DOR 11.1 vs 8.6mo,ORR 48.1% vs 29.3%
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所有患者的PFS 8.4 vs 5.5mo 疾病进展或死亡风险降低38%
DOR 10.6 vs 6.9mo,ORR 51.5% vs 30.2%
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鳞癌患者的PFS 7.1 vs 4.4mo 疾病进展或死亡风险降低49%
DOR 7.9 vs 4.7mo,ORR 59.8% vs 32.4%
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安全性:
Gr3-4的TRAE 45% vs 35%,最常见的贫血10% vs 12%、中性粒细胞减少8% vs 6%、中性粒细胞计数降低7% vs 6%
因TRAE引起的治疗终止20% vs 8%,其中Gr3-4引起的终止10% vs 3%
Nivo联合化疗组的持续治疗时间7.7mo,长于化疗组的2.6mo
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免疫治疗中按组织划分的、需要特别关注的TRAE方面,与先前报道基本一致,发生率不高,大部分Gr 1-2,Gr 3-4很少
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这样的结果也就是为啥来这个会讲了,都是命
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Presentation下载
再看CM817:N+I 1L NSCLC
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这次更新Cohort A和A1的OS和安全性结果
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Cohort A和A1的TRAE 77%和67%,其中Gr 3-4 TRAE 35%和28%
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TRAE的发生及解决时间
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Cohort A的OS 17.0mo,12mo及18mo的OSR 60%和49%
PD-L1阳性的OS 21.4mo ,12mo及18mo的OSR 61%和53%
PD-L1阴性的OS 15.3mo,12mo及18mo的OSR 58%和44%
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Cohort A1的OS 9.9mo,其中ECOG PS2和ASOP的OS 9.0和12.9 mo
PD-L1阳性和阴性的OS 6.9和10.5 mo,12mo 的OSR 41%和48%
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Presentation下载
下面就走流水账了
KN522 and NeoTRIP,直觉K药的1L mTNBC 会在 all comer中做出阳性(KEYNOTE-355)
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DS8201
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palbociclib plus EndocrineTherapy is not superior to capecitabine
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CDKi prime IO
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AR agonism, in contrast with antagonism, in growth inhibition of ER+ breast cancer
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