SCI

20 May 2024

Brief Report: Updated Data From IMscin001 Part 2, a Randomized Phase III Study of Subcutaneous Versus Intravenous Atezolizumab in Patients With Locally Advanced/ Metastatic NSCLC

(Journal of Thoracic Oncology, IF: 20.4)

  • Mauricio Burotto, MD, Zanete Zvirbule, MD, Renzo Alvarez, MD, Busayamas, Chewaskulyong, MD, Luis A. Herraez-Baranda, PhD, Esther Shearer-Kang, PhD, Xiaoyan Liu, PhD, Nadia Tosti, PhD, Patrick Williams, MD PhD, Amparo Yovanna, Castro Sanchez, PhD, James Zanghi, PhD, Enriqueta Felip, MD PhD

  • CORRESPONDENCE TO: Mburotto@bradfordhill.cl.

Introduction 简介

Subcutaneous atezolizumab is approved for the treatment of various solid tumors. Previous results from the IMscin001 study (NCT03735121) demonstrated 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 cut-off: 16 January 2023).

皮下注射阿替利珠单抗被批准用于治疗各种实体瘤。IMscin001研究（NCT03735121）之前的研究结果表明，皮下注射和静脉注射阿替利珠单抗的药代动力学、疗效、免疫原性和安全性是一致的（数据截止日期：2022年4月26日）。我们提供了此次试验的最新数据（截止数据：2023年1月16日）。

 

Methods 方法

Eligible patients aged ≥18 years with locally advanced/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 endpoints, alongside patient-reported outcomes (PROs) and healthcare practitioner (HCP) perspectives.

该试验纳入了符合条件的年龄≥18岁的局部晚期/转移性NSCLC患者随机（2:1）接受阿替利珠单抗皮下注射（1875 mg，n=247）或静脉注射（1200 mg，n=124），每3周一次。本文中我们介绍了疗效的最新数据（总生存期[OS]；无进展生存期；客观反应率；反应持续时间）、安全性和免疫原性终点，以及患者报告的结果（PROs）和医护人员（HCP）的观点。

 

Results 结果

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 4–8 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 (HR: 0.88; 95% CI: 0.67–1.16). Other efficacy endpoints, as well as immunogenicity, PROs, 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.

在这项最新分析中，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（75.7%）的平均皮下注射时间是4-8分钟。OS数据已成熟：治疗组之间的中位OS相似，皮下注射组和静脉注射组的OS分别为10.7个月和10.1个月（HR:0.88；95%CI:0.67–1.16）。其他疗效终点，以及免疫原性、PROs和安全性，在不同组之间相似。大多数HCP认为皮下给药方便（79.5%），易于操作（89.7%），治疗满意度高（84.6%）；75.0%的HCP认为，与静脉注射相比，皮下注射阿替利珠单抗可以节省时间。

 

Conclusions 结论

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.

在这项分析中，不同治疗方式的成熟OS数据相似。皮下注射阿替利珠单抗的最新疗效和安全性与先前的研究结果一致，相当于静脉注射阿替利珠单抗。