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Association details:
| Biomarker: | TMB-H |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Tecentriq (atezolizumab) (PD-L1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
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
Published date:
08/22/2022
Excerpt:
NON-SUPPORTIVE EVIDENCE: 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).
DOI:
https://doi.org/10.1038/s41591-022-01933-w
Trial ID:
Test:
Source:
Title:
LBA1 - Clinical efficacy of atezolizumab (atezo) in biomarker subgroups by SP142, SP263 and 22C3 PD-L1 immunohistochemistry (IHC) assays and by blood tumour mutational burden (bTMB): Results from the IMpower110 study
Published date:
12/12/2019
Excerpt:
Stepwise OS and PFS improvement, favouring atezo, was seen up to bTMB ≥ 16; no further benefit was seen at ≥ 20.
Trial ID:
Source:
Title:
317O - Association of survival and blood-based genomic signature with atezolizumab for patients with second-line and third-line EGFR wild-type non-small cell lung cancer: Pooled analysis of individual patient data from the POPLAR and OAK trials
Published date:
11/24/2019
Excerpt:
...patients with a bTMB-MSAF score<20 showed improvement in OS (HR 0.56; P < 0.001) and progression-free survival (PFS) (HR 0.74; P = 0.0023), and these patients who concurrently had programmed death ligand 1 (PD-L1) expressing on over 50% tumor cells or over 10% of tumor-infiltrating immune cells (TC3 or IC3) had the greatest OS improvements (HR 0.44; P = 0.007) and promising PFS benefits (HR 0.54; P = 0.019).
Source:
Title:
A Study of Atezolizumab as First-line Monotherapy for Advanced or Metastatic Non-Small Cell Lung Cancer (B-F1RST)
Excerpt:
...Progression-Free Survival (PFS) Per RECIST v1.1 as Determined by Investigator, by Positive Versus Negative bTMB Groups...Percentage of Participants Who Are Alive and Progression-Free (Per RECIST v1.1) at 6, 9, 12, and 18 Months by Various bTMB Quantiles...OS by Various bTMB Cutoff Points 16 and 20...Percentage of Participants With Objective Response (Per RECIST v1.1) by Various bTMB Quantiles...
Trial ID:
Source:
Title:
OA06.06 - Clinical/Biomarker Data for Neoadjuvant Atezolizumab in Resectable Stage IB-IIIB NSCLC: Primary Analysis in the LCMC3 Study
Published date:
01/12/2021
Excerpt:
Patients received neoadjuvant atezolizumab 1200 mg intravenously every 3 weeks for ≤2 cycles followed by surgical resection…patients with higher TMB trended toward better pathological response.
Trial ID:
Source:
Title:
318O - Both low and high blood tumour mutational burden are favourable predictors with atezolizumab
Published date:
11/24/2019
Excerpt:
The median PFS and OS of patients with low and high bTMB were significantly longer than those of patients with medium bTMB in multivariate analysis. Both high and low bTMB were associated with better clinical benefit with atezolizumab.
Source:
Title:
FINAL 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)
Published date:
09/29/2019
Excerpt:
In bTMB ≥ 16 vs < 16, mPFS was 5.0 vs 3.5 mo and mOS was 23.9 vs 13.4 mo (Table).
DOI:
10.1093/annonc/mdz394
Trial ID:
Source:
Title:
Association of high tissue TMB and atezolizumab efficacy across multiple tumor types.
Excerpt:
High tTMB (≥16 mut/Mb) is associated with improved atezo response and DoR across NSCLC, mUC and melanoma and lines of therapy.
DOI:
10.1200/JCO.2018.36.15_suppl.12000
