Primary efficacy results from B-F1RST, a prospective phase II trial evaluating blood-based tumour mutational burden (bTMB) as a predictive biomarker for atezolizumab (atezo) in 1L non-small cell lung cancer (NSCLC)

Relationship Between Progression‐Free Survival, Objective Response Rate, and Overall Survival in Clinical Trials of PD‐1/PD‐L1 Immune Checkpoint Blockade: A Meta‐Analysis

“…Tumor mutation burden (TMB) has shown promise as a predictive biomarker in several studies. 29,[74][75][76][77][78] Thus, although TMB might have been another interesting parameter to evaluate, the limited number of trials reporting results for TMB-defined populations meant such an analysis was not feasible.…”

The Promises and Challenges of Tumor Mutation Burden as an Immunotherapy Biomarker: A Perspective from the International Association for the Study of Lung Cancer Pathology Committee

“…In this phase II study, ORR was 28.6% compared with 4.4% for high versus low bTMB, using a prespecified cutoff of 16 mutations/ sample (bTMB score of 16 z 14.5 mutations per Mb). 40 At the time of the final analysis (at least 18 months of follow up), PFS was 3.5 months in the TMB-low versus 5.0 months for the TMB-high category (HR 0.80; 90% CI: 0.54-1.18), and OS was 13.4 months in the TMB-low and 23.9 months in the TMB-high category (HR 0.66; 90% CI: 0.40-1.10). HR for PFS and OS improved between high and low bTMB groups with increasing bTMB thresholds, from HR 1.16 and 0.95 at a threshold of bTMB greater than or equal to 10 to HR 0.59 and 0.44, respectively, at a threshold of bTMB greater than or equal to 20.…”

STK11 (LKB1) mutations in metastatic NSCLC: Prognostic value in the real world

“…Biomarkers identifying those more or less likely to derive treatment benefit, including from immunotherapy (IO) and chemotherapy, may help avoid unnecessary toxicity. PD-L1 expression on tumor cells has been used to guide treatment selection, and more recently tumor mutational burden (TMB) has shown potential as a predictive biomarker for IO benefit [12][13][14][15]. Mutations in individual genes and co-mutation patterns have also been linked to patient response to standard chemotherapy and/or IO in advanced NSCLC [16][17][18][19][20][21][22][23][24].…”