Clin Cancer Res:PD-L1抗体单药或联合TIM-3抗体在MSI-H/dMMR晚期肿瘤中的抗肿瘤活性和安全性

2021-11-21 Nebula MedSci原创

两种治疗方案在PD-1/PD-L1抑制剂初治的MSI-H/dMMR肿瘤中都展现出了可喜的临床活性

免疫检查点抑制剂在微卫星不稳定性-高/错配修复缺陷 (MSI-H/dMMR) 肿瘤中表现出高应答率和持久的临床效益。但是,约50%-60%的肿瘤患者对单剂抗PD-1/PD-L1抗体无反应,而且约50%的应答者会在6-12个月内复发。

这是一项Ib期的临床试验,旨在评估抗PD-L1抗体LY3300054单药或联合抗TIM-3抗体LY3321367在微卫星不稳定性-高/错配修复缺陷的晚期实体瘤患者中的抗肿瘤活性和安全性。

招募了年满18岁的既往未接受过抗PD-1/PD-L1治疗的明确存在微卫星不稳定性-高/错配修复缺陷的晚期实体肿瘤患者,予以LY3300054单药(单药组,n=40)或LY3300054+LY3321367(初治联合组,n=20)治疗;PD-1/PD-L1抑制剂耐药/难治性患者接受联合治疗(耐药/难治性联合组,n=22)。联合组主要终点是安全性和耐受性。次要终点是客观缓解率。

共招募了82位患者,大部分是结直肠癌(n=39, 47.6%)或子宫内膜癌(n=14, 17.1%)。在PD-1/PD-L1抑制剂耐药/难治性联合组中,70%以上的患者既往治疗线数≥3。

三个治疗组治疗相关的不良反应的发生情况

单药组有22位(55.0%)患者发生了治疗相关的不良反应(TRAE),其中2例(5.0%)为≥3级的TRAE;联合组有13位(65.0%)发生了TRAE,3例(7.1%)为≥3级的TRAE。PD-1/PD-L1抑制剂耐药/难治性联合组中有6位(27.3%)发生了TRAE。

三个治疗组患者的治疗反应

单药组和PD-1/PD-L1抑制剂初治联合组分别有13位(32.5%)和9位(45.0%)患者获得了客观缓解;PD-1/PD-L1抑制剂耐药/难治性联合组有1位(4.5%)获得了客观缓解。

综上,LY3300054单药和LY3300054/抗TIM-3联合方案具有可控的安全性。两种治疗方案在PD-1/PD-L1抑制剂初治的MSI-H/dMMR肿瘤中都展现出了可喜的临床活性。但PD-1/PD-L1抑制剂耐药/难治性患者采用该联合方案治疗的获益有限。

原始出处:

Antoine Hollebecque, et al. Safety and Antitumor Activity of α-PD-L1 Antibody as Monotherapy or in Combination with α-TIM-3 Antibody in Patients with Microsatellite Instability–High/Mismatch Repair–Deficient Tumors. Clin Cancer Res November 11 2021 DOI:10.1158/1078-0432.CCR-21-0261

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    2022-07-06 cmsvly
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    2021-11-23 smartjoy
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    2021-11-23 vividelife
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    2021-11-23 小几洁
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    2021-11-23 ms9000000634690473

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