دورية أكاديمية
Bintrafusp Alfa With CCRT Followed by Bintrafusp Alfa Versus Placebo With CCRT Followed by Durvalumab in Patients With Unresectable Stage III NSCLC: A Phase 2 Randomized Study.
| العنوان: | Bintrafusp Alfa With CCRT Followed by Bintrafusp Alfa Versus Placebo With CCRT Followed by Durvalumab in Patients With Unresectable Stage III NSCLC: A Phase 2 Randomized Study. |
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| المؤلفون: | Vokes EE; University of Chicago Medicine and Biological Sciences, Chicago, Illinois., Mornex F; Centre Hospitalier Universitaire, Lyon, France., Sezer A; Baskent University Adana Application and Research Center, Turkey., Cheng Y; Jilin Cancer Hospital, People's Republic of China., Fang J; Beijing Cancer Hospital, People's Republic of China., Baz DV; Hospital Universitario Virgen Macarena, Spain., Cil T; Adana City Hospital, Health and Science University, Adana, Turkey., Adjei AA; Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio., Ahn MJ; Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea., Barlesi F; Aix-Marseille University, Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM), Cancer Research Center of Marseille (CRCM), Assistance Publique Hopitaux de Marseille (APHM), Marseille, France; Paris-Saclay University, Gustave Roussy Cancer Campus, Villejuif, France., Felip E; Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), UVic-UCC, IOB-Quiron, Barcelona, Spain., Garon EB; David Geffen School of Medicine at the University of California, Los Angeles (UCLA), Los Angeles, California., Audhuy F; Merck Serono S.A.S. (an affiliate of Merck KGaA, Darmstadt, Germany), Lyon, France., Ito R; Merck Biopharma Co., Ltd., (an affiliate of Merck KGaA, Darmstadt, Germany), Tokyo, Japan., Sato M; Merck Biopharma Co., Ltd., (an affiliate of Merck KGaA, Darmstadt, Germany), Tokyo, Japan., Eggleton SP; Merck Sereno Ltd. Feltham (an affiliate of Merck KGaA, Darmstadt, Germany), Feltham, United Kingdom., Martin CM; Alexander Fleming Institute, Buenos Aires, Argentina., Reck M; Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany., Robinson CG; Washington University in St. Louis School of Medicine, St. Louis, Missouri., Paz-Ares L; Hospital Universitario 12 de Octubre, CNIO-H12o Lung Cancer Unit, Ciberonc, Madrid, Spain; Complutense University, Madrid, Spain. Electronic address: lpazaresr@seom.org. |
| المصدر: | Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer [J Thorac Oncol] 2024 Feb; Vol. 19 (2), pp. 285-296. Date of Electronic Publication: 2023 Oct 04. |
| نوع المنشور: | Randomized Controlled Trial; Clinical Trial, Phase II; Multicenter Study; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: United States NLM ID: 101274235 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1556-1380 (Electronic) Linking ISSN: 15560864 NLM ISO Abbreviation: J Thorac Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2016- : New York, NY : Elsevier Original Publication: Hagerstown, MD : Lippincott Williams & Wilkins, c2006- |
| مواضيع طبية MeSH: | Carcinoma, Non-Small-Cell Lung*/drug therapy , Lung Neoplasms*/drug therapy, Humans ; Antibodies, Monoclonal/therapeutic use ; Chemoradiotherapy ; Immunologic Factors/therapeutic use ; Neoplasm Staging |
| مستخلص: | Introduction: Preclinical evaluation of bintrafusp alfa (BA) combined with radiotherapy revealed greater antitumor effects than BA or radiotherapy alone. In a phase 1 study, BA exhibited encouraging clinical activity in patients with stage IIIB or IV NSCLC who had received previous treatment. Methods: This multicenter, double-blind, controlled phase 2 study (NCT03840902) evaluated the safety and efficacy of BA with concurrent chemoradiotherapy (cCRT) followed by BA (BA group) versus placebo with cCRT followed by durvalumab (durvalumab group) in patients with unresectable stage III NSCLC. The primary end point was progression-free survival according to Response Evaluation Criteria in Solid Tumors version 1.1 as assessed by the investigator. On the basis of the recommendation of an independent data monitoring committee, the study was discontinued before the maturity of overall survival data (secondary end point). Results: A total of 153 patients were randomized to either BA (n = 75) or durvalumab groups (n = 78). The median progression-free survival was 12.8 months versus 14.6 months (stratified hazard ratio = 1.48 [95% confidence interval: 0.69-3.17]), in the BA and durvalumab groups, respectively. Trends for overall response rate (29.3% versus 32.1%) and disease control rate (66.7% versus 70.5%) were similar between the two groups. Any-grade treatment-emergent adverse events occurred in 94.6% versus 96.1% of patients in the BA versus durvalumab groups, respectively. Bleeding events in the BA group were mostly grade 1 (21.6%) or 2 (9.5%). Conclusions: BA with cCRT followed by BA exhibited no efficacy benefit over placebo with cCRT followed by durvalumab in patients with stage III unresectable NSCLC. (Copyright © 2023 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Bifunctional; Bintrafusp alfa; Concurrent chemoradiotherapy; Non–small cell lung cancer; TGF-β |
| المشرفين على المادة: | 0 (Antibodies, Monoclonal) 28X28X9OKV (durvalumab) 0 (Immunologic Factors) |
| تواريخ الأحداث: | Date Created: 20231005 Date Completed: 20240220 Latest Revision: 20240226 |
| رمز التحديث: | 20240226 |
| DOI: | 10.1016/j.jtho.2023.09.1452 |
| PMID: | 37797733 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1556-1380 |
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| DOI: | 10.1016/j.jtho.2023.09.1452 |