背景:皮下阿替珠单抗被批准用于治疗各种实体瘤。IMscin001研究(NCT03735121)的先前结果表明,功效,免疫原性,皮下和静脉阿替珠单抗的安全性一致(数据截止:2022年4月26日)。我们提供了该试验的最新数据(数据截止日期:2023年1月16日)。
方法:年龄≥18岁的局部晚期/转移性非小细胞肺癌患者随机(2:1)接受阿特珠单抗皮下(1875mg,n=247)或静脉注射(1200毫克,n=124)每3周。在这里,我们提出了更新的疗效(总生存期[OS];无进展生存期;客观缓解率;缓解持续时间),安全,和免疫原性终点,以及患者报告的结果(PRO)和保健医生(HCP)的观点。
结果:在此更新的分析中,中位生存随访时间为9.5个月.中位皮下注射时间为7.1分钟,大多数患者的平均皮下注射时间为4-8分钟(75.7%)。OS数据是成熟的:治疗组之间的中位OS相似,在10.7和10.1个月的皮下和静脉内手臂,分别(HR:0.88;95%CI:0.67-1.16)。其他疗效终点,以及免疫原性,PROs,和安全,武器之间是相似的。大多数HCP发现皮下给药方便(79.5%),易于管理(89.7%),并且对治疗感到满意(84.6%);75.0%的HCP认为阿替珠单抗皮下给药与静脉给药相比可以节省时间.
结论:在此分析中,不同治疗组的成熟OS数据相似。皮下阿妥珠单抗的最新疗效和安全性与以前的发现一致,相当于静脉阿妥珠单抗。
BACKGROUND: Subcutaneous atezolizumab is approved for the treatment of various solid tumors. Previous results from the IMscin001
study (NCT03735121) revealed that the pharmacokinetics, efficacy, immunogenicity, and safety of subcutaneous and
intravenous atezolizumab were consistent (data cutoff: April 26, 2022). We present updated data from this
trial (data cutoff: January 16, 2023).
METHODS: Eligible patients aged above or equal to 18 years with locally advanced or metastatic NSCLC were randomized (2:1) to receive atezolizumab subcutaneously (1875 mg, n = 247) or intravenously (1200 mg, n = 124) every 3 weeks. Here, we present updated efficacy (overall survival [OS]; progression-free survival; objective response rate; duration of response), safety, and immunogenicity end points, alongside patient-reported outcomes and health care practitioner (HCP) perspectives.
RESULTS: In this updated analysis, the median survival follow-up was 9.5 months. Median subcutaneous injection time was 7.1 minutes, with an average subcutaneous injection time of 4 to 8 minutes in most patients (75.7%). OS data were mature: median OS was similar between treatment arms, at 10.7 and 10.1 months in the subcutaneous and
intravenous arms, respectively (hazard ratio: 0.88; 95% confidence interval: 0.67-1.16). Other efficacy end points, as well as immunogenicity, patient-reported outcomes, and safety, were similar between arms. Most HCPs found subcutaneous administration convenient (79.5%), easy to administer (89.7%), and were satisfied with the treatment (84.6%); 75.0% of HCPs agreed that administering atezolizumab subcutaneously compared with intravenously could save time.
CONCLUSIONS: In this analysis, mature OS data were similar between treatments. The updated efficacy and safety profile of subcutaneous atezolizumab is consistent with previous findings and equivalent to
intravenous atezolizumab.