دورية أكاديمية

Atezolizumab versus chemotherapy in advanced or metastatic NSCLC with high blood-based tumor mutational burden: primary analysis of BFAST cohort C randomized phase 3 trial

التفاصيل البيبلوغرافية
العنوان: Atezolizumab versus chemotherapy in advanced or metastatic NSCLC with high blood-based tumor mutational burden: primary analysis of BFAST cohort C randomized phase 3 trial
المؤلفون: Peters, Solange, Dziadziuszko, Rafal, Morabito, Alessandro, Felip, Enriqueta, Gadgeel, Shirish M, Cheema, Parneet, Cobo, Manuel, Andric, Zoran, Barrios, Carlos H, Yamaguchi, Masafumi, Dansin, Eric, Danchaivijitr, Pongwut, Johnson, Melissa, Novello, Silvia, Mathisen, Michael S, Shagan, Sarah M, Schleifman, Erica, Wang, Jin, Yan, Mark, Mocci, Simonetta, Voong, David, Fabrizio, David A, Shames, David S, Riehl, Todd, Gandara, David R, Mok, Tony
المصدر: Hematology/Oncology Articles
بيانات النشر: Henry Ford Health Scholarly Commons
سنة النشر: 2022
المجموعة: Henry Ford Health System Scholarly Commons
مصطلحات موضوعية: Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, Carcinoma, Non-Small-Cell Lung, Humans, Immunotherapy, Lung Neoplasms
الوصف: Tumor mutational burden (TMB) is being explored as a predictive biomarker for cancer immunotherapy outcomes in non-small cell lung cancer. BFAST (NCT03178552)-an open-label, global, multicohort trial-evaluated the safety and efficacy of first-line targeted therapies or immunotherapy in patients with unresectable Stage IIIB or IV advanced or metastatic non-small cell lung cancer who were selected for biomarker status using blood-based targeted next-generation sequencing. In the Phase 3 cohort C evaluating blood-based (b)TMB as a biomarker of atezolizumab efficacy, patients with bTMB of ≥10 (N = 471) were randomized 1:1 to receive atezolizumab or platinum-based chemotherapy per local standard of care. Cohort C did not meet its primary endpoint of investigator-assessed progression-free survival in the population with bTMB of ≥16 (hazard ratio, 0.77; 95% confidence interval: 0.59, 1.00; P = 0.053). Adverse events leading to treatment withdrawal occurred in 10% of patients in the atezolizumab arm and 20% in the chemotherapy arm. Adverse events of special interest occurred in 42% of patients in the atezolizumab arm and 26% in the chemotherapy arm. A prespecified exploratory analysis compared the bTMB clinical trial assay with the FoundationOne Liquid Companion Diagnostic assay and showed high concordance between assays. Additional exploration of bTMB to identify optimal cutoffs, confounding factors, assay improvements or cooperative biomarkers is warranted.
نوع الوثيقة: text
وصف الملف: application/pdf
اللغة: unknown
العلاقة: https://scholarlycommons.henryford.com/hematologyoncology_articles/250Test; http://sfxhosted.exlibrisgroup.com/hfhs?sid=Entrez:PubMed&id=pmid:35995953Test
الإتاحة: https://scholarlycommons.henryford.com/hematologyoncology_articles/250Test
http://sfxhosted.exlibrisgroup.com/hfhs?sid=Entrez:PubMed&id=pmid:35995953Test
رقم الانضمام: edsbas.2D009C69
قاعدة البيانات: BASE