Effectiveness and safety of Atezolizumab in patients with locally-advanced or metastatic non-small cell lung cancer after prior chemotherapy under real-life conditions in Germany: The Non-interventional Study HYPERION

Q3 Medicine

Cancer treatment and research communications Pub Date : 2024-01-01 DOI:10.1016/j.ctarc.2025.100878

Niels Reinmuth , Christian Geßner , Thomas Schichtl , Wolfgang Schütte , Stefan Hammerschmidt , Holger Schulz , Max Zortel , Ralf Zerbes , Martin Reck

{"title":"Effectiveness and safety of Atezolizumab in patients with locally-advanced or metastatic non-small cell lung cancer after prior chemotherapy under real-life conditions in Germany: The Non-interventional Study HYPERION","authors":"Niels Reinmuth , Christian Geßner , Thomas Schichtl , Wolfgang Schütte , Stefan Hammerschmidt , Holger Schulz , Max Zortel , Ralf Zerbes , Martin Reck","doi":"10.1016/j.ctarc.2025.100878","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Atezolizumab is the first approved PD-L1 inhibitor for patients with advanced non-small cell lung cancer (NSCLC) in Germany. This study aimed to assess effectiveness and safety of this checkpoint inhibitor in clinical routine practice. In addition, potential correlating factors between patient or disease characteristics and clinical benefit of atezolizumab were addressed.</div></div><div><h3>Methods</h3><div>HYPERION was a prospective, multicenter, non-interventional, two-cohort study collecting primary data in patients with locally-advanced or metastatic NSCLC after prior chemotherapy treated with atezolizumab.</div><div>Patients were assigned to one of two cohorts depending on their clinical benefit from atezolizumab, i.e., lack of benefit (Cohort 1) or durability of clinical benefit and tumor response (Cohort 2), as assessed by the physicians.</div></div><div><h3>Results</h3><div>Between May 2018 and August 2023, 353 patients were observed, including 179 in Cohort 1 and 174 in Cohort 2. The median age was 68 years and 61 % were men.</div><div>The median time to loss of clinical benefit was 106 days (95 % CI: 93, 119) overall (<em>n</em> = 353 patients) and 256 days (95 % CI: 210, 339) for Cohort 2 (<em>n</em> = 174 patients).</div><div>In total, 243 (68.8 %) patients experienced at least one adverse event (AE) and 146 (41.4 %) patients at least one serious AE.</div><div>A higher proportion of PD-L1 positive patients was observed for Cohort 2 than for Cohort 1.</div></div><div><h3>Conclusion</h3><div>HYPERION confirmed effectiveness of atezolizumab in clinical practice. Results supported a known correlation between PD-L1 expression and a higher benefit of atezolizumab treatment. Atezolizumab treatment was associated with an acceptable safety profile.</div></div><div><h3>Micro abstract</h3><div>The two-cohort non-interventional study HYPERION assessed the effectiveness and safety of atezolizumab in 353 patients with locally-advanced or metastatic NSCLC after prior chemotherapy, depending on lack of benefit (Cohort 1; <em>n</em> = 179) or durability of clinical benefit and tumor response (Cohort 2; <em>n</em> = 174). Atezolizumab showed effectiveness in clinical practice. Results were consistent with the known safety profile.</div></div>","PeriodicalId":9507,"journal":{"name":"Cancer treatment and research communications","volume":"43 ","pages":"Article 100878"},"PeriodicalIF":0.0000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer treatment and research communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2468294225000164","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Atezolizumab is the first approved PD-L1 inhibitor for patients with advanced non-small cell lung cancer (NSCLC) in Germany. This study aimed to assess effectiveness and safety of this checkpoint inhibitor in clinical routine practice. In addition, potential correlating factors between patient or disease characteristics and clinical benefit of atezolizumab were addressed.

Methods

HYPERION was a prospective, multicenter, non-interventional, two-cohort study collecting primary data in patients with locally-advanced or metastatic NSCLC after prior chemotherapy treated with atezolizumab.

Patients were assigned to one of two cohorts depending on their clinical benefit from atezolizumab, i.e., lack of benefit (Cohort 1) or durability of clinical benefit and tumor response (Cohort 2), as assessed by the physicians.

Results

Between May 2018 and August 2023, 353 patients were observed, including 179 in Cohort 1 and 174 in Cohort 2. The median age was 68 years and 61 % were men.

The median time to loss of clinical benefit was 106 days (95 % CI: 93, 119) overall (n = 353 patients) and 256 days (95 % CI: 210, 339) for Cohort 2 (n = 174 patients).

In total, 243 (68.8 %) patients experienced at least one adverse event (AE) and 146 (41.4 %) patients at least one serious AE.

A higher proportion of PD-L1 positive patients was observed for Cohort 2 than for Cohort 1.

Conclusion

HYPERION confirmed effectiveness of atezolizumab in clinical practice. Results supported a known correlation between PD-L1 expression and a higher benefit of atezolizumab treatment. Atezolizumab treatment was associated with an acceptable safety profile.

Micro abstract

The two-cohort non-interventional study HYPERION assessed the effectiveness and safety of atezolizumab in 353 patients with locally-advanced or metastatic NSCLC after prior chemotherapy, depending on lack of benefit (Cohort 1; n = 179) or durability of clinical benefit and tumor response (Cohort 2; n = 174). Atezolizumab showed effectiveness in clinical practice. Results were consistent with the known safety profile.

查看原文本刊更多论文

求助全文

约1分钟内获得全文求助全文

来源期刊

Cancer treatment and research communications Medicine-Oncology

CiteScore

4.30

自引率

0.00%

发文量

148

审稿时长

56 days

期刊介绍： Cancer Treatment and Research Communications is an international peer-reviewed publication dedicated to providing comprehensive basic, translational, and clinical oncology research. The journal is devoted to articles on detection, diagnosis, prevention, policy, and treatment of cancer and provides a global forum for the nurturing and development of future generations of oncology scientists. Cancer Treatment and Research Communications publishes comprehensive reviews and original studies describing various aspects of basic through clinical research of all tumor types. The journal also accepts clinical studies in oncology, with an emphasis on prospective early phase clinical trials. Specific areas of interest include basic, translational, and clinical research and mechanistic approaches; cancer biology; molecular carcinogenesis; genetics and genomics; stem cell and developmental biology; immunology; molecular and cellular oncology; systems biology; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; cancer policy; and integration of various approaches. Our mission is to be the premier source of relevant information through promoting excellence in research and facilitating the timely translation of that science to health care and clinical practice.