RT Journal Article
T1 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.
A1 Peters, Solange
A1 Dziadziuszko, Rafal
A1 Morabito, Alessandro
A1 Felip, Enriqueta
A1 Gadgeel, Shirish M
A1 Cheema, Parneet
A1 Cobo, Manuel
A1 Andric, Zoran
A1 Barrios, Carlos H
A1 Yamaguchi, Masafumi
A1 Dansin, Eric
A1 Danchaivijitr, Pongwut
A1 Johnson, Melissa
A1 Novello, Silvia
A1 Mathisen, Michael S
A1 Shagan, Sarah M
A1 Schleifman, Erica
A1 Wang, Jin
A1 Yan, Mark
A1 Mocci, Simonetta
A1 Voong, David
A1 Fabrizio, David A
A1 Shames, David S
A1 Riehl, Todd
A1 Gandara, David R
A1 Mok, Tony
K1 Carcinoma, Non-Small-Cell Lung
K1 Progression-Free Survival
K1 Lung Neoplasms
K1 Immunotherapy
K1 High-Throughput Nucleotide Sequencing
AB 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.
PB Nature Publishing Group
YR 2022
FD 2022-08-22
LK http://hdl.handle.net/10668/19573
UL http://hdl.handle.net/10668/19573
LA en
NO Peters S, Dziadziuszko R, Morabito A, Felip E, Gadgeel SM, Cheema P, et al. 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. Nat Med. 2022 Sep;28(9):1831-1839
DS RISalud
RD Apr 19, 2025