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Association details:
Biomarker:TMB-H
Cancer:Breast Cancer
Drug:Keytruda (pembrolizumab) (PD1 inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
Breast cancer: Invasive Breast Cancer...ADDITIONAL TARGETED THERAPIES AND ASSOCIATED BIOMARKER TESTING FOR RECURRENT OR STAGE IV (m1) DISEASE…Any…TMB-H…pembrolizumab
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
Title:

Pembrolizumab in Patients With Metastatic Breast Cancer With High Tumor Mutational Burden: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Published date:
04/12/2021
Excerpt:
Patients with advanced mBC received standard doses of either 2 mg/kg or 200 mg infusions of pembrolizumab every 3 weeks....All patients' tumors had HTMB ranging from 9 to 37 mutations/megabase. DC and objective response were noted in 37% (95% CI, 21 to 50) and 21% of patients (95% CI, 8 to 41), respectively. Median PFS was 10.6 weeks (95% CI, 7.7 to 21.1); median overall survival was 30.6 weeks (95% CI, 18.3 to 103.3).
DOI:
10.1200/JCO.20.02923
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Pembrolizumab (P) in patients (pts) with metastatic breast cancer (MBC) with high tumor mutational burden (HTMB): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Excerpt:
P demonstrated anti-tumor activity in heavily pre-treated MBC pts with HTMB.
DOI:
10.1200/JCO.2019.37.15_suppl.1014
Trial ID: