Association of tumour mutational burden with outcomes in patients with advanced solid tumours treated with pembrolizumab: prospective biomarker analysis of the�…

A Marabelle, M Fakih, J Lopez, M Shah…�- The Lancet�…, 2020 - thelancet.com
Background Tumour mutational burden (TMB) has been retrospectively correlated with
response to immune checkpoint blockade. We prospectively explored the association of�…

[HTML][HTML] Association of tumour mutational burden with outcomes in patients with select advanced solid tumours treated with pembrolizumab in KEYNOTE-158

A Marabelle, MG Fakih, J Lopez, M Shah…�- Annals of oncology, 2019 - Elsevier
Background Tumor mutational burden (TMB) has been correlated with response to CTLA-4
and PD-(L) 1 inhibitors. We explored the association of TMB with outcomes in cohorts A�…

[HTML][HTML] Tumor mutational burden predicts the efficacy of pembrolizumab monotherapy: a pan-tumor retrospective analysis of participants with advanced solid tumors

R Cristescu, D Aurora-Garg, A Albright…�- …�for immunotherapy of�…, 2022 - ncbi.nlm.nih.gov
Background Several studies have evaluated the relationship between tumor mutational
burden (TMB) and outcomes of immune checkpoint inhibitors. In the phase II KEYNOTE-158�…

FDA approval summary: pembrolizumab for the treatment of tumor mutational burden–high solid tumors

L Marcus, LA Fashoyin-Aje, M Donoghue, M Yuan…�- Clinical Cancer�…, 2021 - AACR
The FDA approved pembrolizumab on June 16, 2020, for the treatment of adult and pediatric
patients with unresectable or metastatic tumor mutational burden–high [TMB-H;≥ 10�…

[HTML][HTML] Tumor mutational burden as a pan-cancer biomarker for immunotherapy: the limits and potential for convergence

A Passaro, A Stenzinger, S Peters�- Cancer Cell, 2020 - cell.com
A recent study in The Lancet Oncology reports that high tumor mutational burden (TMB) is
associated with response to anti-PD-1 pembrolizumab, leading to the second FDA approval�…

Pembrolizumab in patients with tumors with high tumor mutational burden: results from the targeted agent and profiling utilization registry study

HL Duvivier, M Rothe, PK Mangat…�- Journal of Clinical�…, 2023 - ascopubs.org
PURPOSE The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a
pragmatic basket trial evaluating antitumor activity of approved targeted agents in patients�…

[HTML][HTML] The FDA approval of pembrolizumab for adult and pediatric patients with tumor mutational burden (TMB)≥ 10: a decision centered on empowering patients�…

V Subbiah, DB Solit, TA Chan…�- Annals of�…, 2020 - annalsofoncology.org
On 16 June 2020, the US Food and Drug Administration (FDA) granted accelerated
approval to pembrolizumab for the treatment of 'adult and pediatric patients with�…

[HTML][HTML] Associations of tissue tumor mutational burden and mutational status with clinical outcomes with pembrolizumab plus chemotherapy versus chemotherapy for�…

MC Garassino, S Gadgeel, S Novello, B Halmos…�- JTO Clinical and�…, 2023 - Elsevier
Introduction We evaluated tissue tumor mutational burden (tTMB) and mutations in STK11,
KEAP1, and KRAS as biomarkers for outcomes with pembrolizumab plus platinum-based�…

Tumor mutational burden as a predictive biomarker in solid tumors

D Sha, Z Jin, J Budczies, K Kluck, A Stenzinger…�- Cancer discovery, 2020 - AACR
Tumor mutational burden (TMB), defined as the number of somatic mutations per megabase
of interrogated genomic sequence, varies across malignancies. Panel sequencing–based�…

Tumor mutational burden as a predictor of immunotherapy response: is more always better?

JH Strickler, BA Hanks, M Khasraw�- Clinical Cancer Research, 2021 - AACR
Immune checkpoint inhibitors, including antibodies that block programmed cell death protein-
1 (PD-1) and PD-L1, have transformed the management of many cancers. However, the�…