CHECKMATE-649中国亚组数据.pptxVIP

CheckMate 649研究：比较双免疫联合 vs 免疫联合化疗 vs 单用化疗一线治疗晚期或转移性胃癌/胃食管结合部癌—中国亚组数据随机、多中心、开放性III期研究该臂停止入组关键入组标准： 年龄 ≥ 18 岁不可切除的进展期或复发胃/胃食管交界处癌既往未经系统治疗包括HER2靶向治疗等作为初始治疗可检测肿瘤组织标本 ≤6个月ECOG PS (0 vs 1) N=2032 Nivo 1mg/kg Ipi 3mg/kg Q3W x 4Nivo 单药240 mg Q2W主要终点:PD-L1 CPS≥5 的PFS, OS(Nivo+化疗 vs. 化疗)次要终点:? 总体OS 或CPS≥1 OS? PFS （CPS≥10,1或总体）? ORR* Nivo 360 mg + XELOX Q3W 或NIVO 240 mg + FOLFOX Q2WdN=789 比例1:1:1研究者选择 N=792 或者奥沙利铂 + 卡培他滨 Q3W分层依据:PD-L1表达 (≥1% vs. 1%) ；ECOG PS (0 vs 1)；地区 (亚洲 vs 美国 vs 其他)XELOX vs FOLFOX奥沙利铂 +亚叶酸钙+氟尿嘧啶 Q2W全球多中心研究，包括中国ClinicalTrials.gov. NC 2. Moehler M, et al. LBA .ESMO2020中国患者的基线特征PD-L1 CPS ≥ 5所有人群NIVO + chemo (n = 75)Chemo (n = 81)NIVO + chemo (n = 99)Chemo (n = 109)中位年龄(范围), 年61 (23-77)60 (29-85)61 (23-83)60 (21-85)男性, COG PS 1, 发肿瘤位置%胃食管结合部癌1114912转移性疾病, 转移, 门螺杆菌感染,b %36483849MSI 状态,c,d %MSSI-H0212研究中接受FOLFOX/XELOX比例,e %15/8513/8719/8114/86PD-L1 CPS≥ 5患者的基线特征分布与所有随机的中国患者一致CheckMate 649aNo Chinese patients with EAC were enrolled; bHelicobacter pylori status was unknown or not reported for 34 patients in the NIVO + chemo arm and 27 patients in the chemo arm; cMSI status was not available for 1 patient in the NIVO + chemo arm; dPercentages may not add up to 100% due to rounding; eAll Treated Chinese patients with PD-L1 CPS ≥ 5: NIVO + chemo, n = 75 and chemo, n = 78.CheckMate 649中国患者治疗暴露倾向全部治疗NIVO + chemo (n = 99)Chemo (n = 106)NIVO + XELOX(n = 80)NIVO + FOLFOX(n = 19)XELOX(n = 91)FOLFOX (n = 15)中位持续治疗时间(范围), 月6.3 (0.1–32.6)6.5 (1.0-30.0)4.0 (0.0–29.2)3.9 (0.8-30.3)治疗中止, n (%)84 (85)103 (97)治疗中止原因, n (%)疾病进展56 (57)74 (70)治疗相关AE11 (11)9 (9)非治疗相关AE6 (6)0 (0)患者要求5 (5)10 (9)其他a6 (6)10 (9)53%的随机化中国患者接受了后续治疗b (NIVO +化疗，47%；化疗，59%)免疫治疗c：NIVO+化疗，3%和化疗，10%aOther reasons for discontinuation included maximum clinical benefit (n = 1), completion of treatment (n = 3), patient no longer met study criteria (n = 3), patient withdrew consent (n = 6), and additional reasons (n = 3); bSubsequent th