基石药业舒格利单抗一线数据亮相ESMO,胃癌、食管鳞癌再迎新突破

2020-09-21 医药魔方 医药魔方

中国是恶性肿瘤发生大国,但每个瘤种又各具特色。

中国是恶性肿瘤发生大国,但每个瘤种又各具特色。胃癌(GC)/胃食管结合部腺癌(GEJ)是全球第二大肿瘤性致死原因,也是中国恶性肿瘤发病数仅次于肺癌的第二大瘤种,2015年发病例达到40多万[1]。既往数据显示,80%患者确诊时已是进展期,即使接受了根治性手术为主的综合治疗,5年生存率仍低于30%[2]。

食管癌也是常见的消化道肿瘤,其发病率在全球恶性肿瘤中排第7位,死亡率排第6位[3];中国每年食管癌新发病例占全球53.7%,死亡病例占全球55.7%,在全国恶性肿瘤中的发病率和死亡率分别位于第6位和第4位[1]。我国食管癌以食管鳞状细胞癌(ESCC)为主,占食管癌90%以上,治疗手段选择有限并且预后较差,总体5年生存率不到30%。75%的患者确诊时已发展为晚期或伴有远端转移,一线治疗失败后的患者中位生存时间近为5~10个月[4],急需新的治疗手段。近年来,免疫疗法打破了多种恶性肿瘤的治疗瓶颈,不断迎来新的突破。

舒格利单抗(CS1001)是由基石药业开发的全人源全长抗PD-L1单克隆抗体,与同类药物相比,舒格利单抗的免疫原性以及在患者体内产生相关毒性的风险更低,这使得CS1001在安全性方面具有独特的优势。早期临床前研究显示,CS1001除了阻断PD-L1和PD-1之间的相互作用以重振功能异常的肿瘤浸润效应T细胞,抑制肿瘤细胞增殖的作用之外,还能够通过将PD-L1阳性肿瘤细胞与巨噬细胞交联来诱导抗体依赖性细胞吞噬作用(ADCP)介导的肿瘤杀伤以及增强T细胞启动的作用。

CS1001联合化疗一线治疗GC/ GEJ和ESCC正在沈琳教授和李进教授的带领下开展国内多中心临床III期试验。ESMO 2020大会上,基石药业带来了CS1001 Ib临床研究中GC/GEJ和ESCC两个队列的最新有效性和安全性数据。

01 研究设计

GC/GEJ(1L)队列:纳入经组织学确认的既往未接受系统治疗且无法手术切除的局部晚期或转移性胃癌或胃食管结合部癌患者。

ESCC (1L)队列:纳入经组织学证实的不可手术切除的局部晚期、复发或转移性食管鳞状细胞癌。

研究中,患者每3周1次注射1200mg固定剂量CS1001,GC/GEJ(1L)队列同时接受最多6个周期的奥沙利铂(130mg/㎡,每3周给药1次)和卡培他滨(1000mg/㎡;口服,每日2次,d1-14);ESCC (1L)队列同时接受5-氟尿嘧啶(800 mg/m2/d,静脉滴注,每3周为1周期)和顺铂(80 mg/m2,静脉滴注,每3周为1周期),所有队列患者给药直至病情恶化或不耐受。

主要研究终点是按照RECISTv1.1标准进行评估的CS1001联合化疗对GC/GEJ或ESCC的治疗效果;次要终点是CS1001联合化疗的安全性和耐受性。

02 研究结果

截至2020年2月19日,GC/GEJ和ESCC队列分别招募了29例和39例患者。

患者基线如下表所示:GC/GEJ队列患者的中位年龄为60岁,89.7%患者为GC,绝大多数患者处于肿瘤晚期(96.6%,Stage Ⅳ); ESCC队列患者的中位年龄为61岁,89.7%患者处于肿瘤晚期(Stage Ⅳ)。

截至2020年2月19日,对GC/GEJ队列的所有29例患者进行有效性分析。有18(62.1%)例患者达到了部分缓解(PR),包括17例确诊的PR和1例未确诊的PR;6例(20.7%)患者疾病稳定(SD);3例(10.3%)患者发生疾病进展(PD)。中位缓解持续时间(mDoR)为11.3 个月,中位无进展生存期(mPFS)8.3个月,中位总生存期(mOS)17.0个月。

截至2020年2月19日,对来自ESCC队列的37例(2例患者在治疗后尚未达到第一次肿瘤评估时间)患者进行有效性分析,有25(67.6%)例达到了PR,包括20例已确认PR和5例未确认PR;SD的患者有8例(21.6%);2例(5.4%)PD;2例(5.4%)患者在未达基线后的肿瘤评估时终止治疗(即不适用)。ORR为68%, mPFS为9.0个月, mDoR和mOS仍未达到。

截至2020年2月19日,在GC/GEJ和ESCC队列中,CS1001治疗的中位时间分别为232天(范围:21-523)和172天(范围:21-488)。安全性方面,在GC/GEJ队列中,与CS1001相关的所有等级和≥3级AEs发生率分别为96.6%和48.3%。其中,与CS1001相关的最常见(n≥2例)≥3级AEs包括血小板计数下降(n=6)、白细胞计数下降(n=3)、中性粒细胞计数下降(n=3)、贫血(n=3 )和疲劳(n=2)。

在ESCC队列中,与CS1001相关的所有等级和≥3级不良事件(AEs)分别为87.2%和41.0%。最常见的(n≥2例)≥3级与CS1001相关的AEs包括贫血(n=6)、白细胞计数减少(n=3)、中性粒细胞计数减少(n=3)、血淀粉酶增加(n=3)、血小板计数降低(n=2)、低钠血症(n=2)和乏力(n=2)。

最后,我们期望在沈琳教授和李进教授两位大咖的领导下,CS1001联合标准化疗(SoC)的两项一线双盲、随机临床III期研究GEMSTONE-303 (CS1001-303, NCT03802591)和GEMSTONE-304 (CS1001-304,NCT04187352)早日取得成功,为患者提供更好一线治疗选择。

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    2021-06-15 liuhuangbo
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    2021-02-10 zxxiang
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    2020-10-29 lovetcm

    #舒格利单抗#看起来应该是相当不错的!

    0

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    2020-09-23 智慧医人
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    2020-09-23 zhouqu_8
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