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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Association of tumor mutational burden (TMB) and clinical outcomes with pembrolizumab (pembro) versus chemotherapy (chemo) in patients with metastatic triple-negative breast cancer (mTNBC) from KEYNOTE-119.

Published date:
05/13/2020
Excerpt:
One-sided P values for the association of TMB and clinical outcomes in pembro-treated patients were 0.154 for ORR, 0.014 for PFS, and 0.018 for OS; the area under the ROC curve ([AUROC] 95% CI) for predicting ORR was 0.58 (0.43-0.73). Two-sided P values for the association of TMB and clinical outcomes in chemo-treated patients were 0.114 for ORR, 0.478 for PFS, and 0.906 for OS; AUROC (95% CI) was 0.43 (0.27-0.59).
DOI:
10.1200/JCO.2020.38.15_suppl.1013
Trial ID:
Evidence Level:
Sensitive: C1 - Off-label
  (Approved for Solid Tumor)
New
Excerpt:
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:...for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Biomarkers predictive of response to pembrolizumab in head and neck cancer

Published date:
12/07/2022
Excerpt:
In multivariate models, TMB, PD-L1, and TcellinfGEP were each independently predictive for ORR (p < 0.001). ORR was higher in patients with high versus low levels of biomarkers… patients with higher versus lower levels of TMB and PD-L1 or TMB and TcellinfGEP had the highest ORRs....TMB and the inflammatory biomarkers PD-L1 and TcellinfGEP, assessed alone or together, may be useful for characterizing clinical response to pembrolizumab in R/M HNSCC.
DOI:
10.1002/cam4.5434
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Influence of tumor mutational burden, inflammatory gene expression profile, and PD-L1 expression on response to pembrolizumab in head and neck squamous cell carcinoma

Published date:
02/01/2022
Excerpt:
To characterize genomic determinants of response to pembrolizumab in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) in the KEYNOTE-012 study….TMB, clonality-weighted TMB, and TcellinfGEP were significantly associated with objective response (p=0.0276, p=0.0201, and p=0.006, respectively), and a positive trend was observed between NL and PD-L1 CPS and clinical response (p=0.0550 and p=0.0682, respectively)....TMB and inflammatory biomarkers (TcellinfGEP and PD-L1) may represent distinct and complementary biomarkers predicting response to anti-programmed death 1 therapies in HNSCC.
DOI:
10.1136/jitc-2021-003026
Evidence Level:
Sensitive: C3 – Early Trials
New
Source:
Title:

Abstract LB-339: Biomarkers predictive of response to pembrolizumab in head and neck cancer (HNSCC)

Excerpt:
TMB, PD-L1 and T-cell inflamed GEP were independently predictive of response to pembrolizumab in HNSCC patients, in general regardless of HPV status.
DOI:
10.1158/1538-7445.AM2018-LB-339
Trial ID: