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
| Autor: | Solange Peters, Rafal Dziadziuszko, Alessandro Morabito, Enriqueta Felip, Shirish M. Gadgeel, Parneet Cheema, Manuel Cobo, Zoran Andric, Carlos H. Barrios, Masafumi Yamaguchi, Eric Dansin, Pongwut Danchaivijitr, Melissa Johnson, Silvia Novello, Michael S. Mathisen, Sarah M. Shagan, Erica Schleifman, Jin Wang, Mark Yan, Simonetta Mocci, David Voong, David A. Fabrizio, David S. Shames, Todd Riehl, David R. Gandara, Tony Mok |
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| Přispěvatelé: | Institut Català de la Salut, [Peters S] Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland. [Dziadziuszko R] Medical University of Gdańsk, Gdańsk, Poland. [Morabito A] Istituto Nazionale Tumori ‘Fondazione G Pascale’, IRCCS, Naples, Italy. [Felip E] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Gadgeel SM] Henry Ford Cancer Institute/Henry Ford Health System, Detroit, MI, USA. [Cheema P] William Osler Health System, University of Toronto, Brampton, Ontario, Canada, Vall d'Hebron Barcelona Hospital Campus |
| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
Lung Neoplasms
phase 3 trial Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy [ANALYTICAL DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT] Marcadors tumorals terapéutica::terapia biológica::inmunomodulación::inmunoterapia [TÉCNICAS Y EQUIPOS ANALÍTICOS DIAGNÓSTICOS Y TERAPÉUTICOS] blood-based tumor Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] factores biológicos::biomarcadores::marcadores tumorales [COMPUESTOS QUÍMICOS Y DROGAS] Atezolizumab versus chemotherapy NSCLC blood-based tumor mutational burden phase 3 trial General Medicine Pulmons - Càncer - Immunoteràpia Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms::Bronchial Neoplasms::Carcinoma Bronchogenic::Carcinoma Non-Small-Cell Lung [DISEASES] neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares::neoplasias de los bronquios::carcinoma broncogénico::carcinoma de pulmón de células no pequeñas [ENFERMEDADES] NSCLC Antibodies Monoclonal Humanized Other subheadings::Other subheadings::/drug therapy [Other subheadings] General Biochemistry Genetics and Molecular Biology Atezolizumab versus chemotherapy Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols Biomarkers Tumor Humans Immunotherapy Biological Factors::Biomarkers::Biomarkers Tumor [CHEMICALS AND DRUGS] mutational burden |
| Zdroj: | Scientia |
| ISSN: | 0317-8552 |
| Popis: | Non-small-cell lung cancer; Predictive markers Càncer de pulmó de cèl·lules no petites; Marcadors predictius Cáncer de pulmón de células no pequeñas; Marcadores predictivos 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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