Non-Small Cell Lung Cancer Coverage from Every Angle

ESMO 2019: Tissue Tumor Mutational Burden and Survival With Pembrolizumab in Lung Cancer

By: Kayci Reyer
Posted: Monday, October 28, 2019

According to research based on pooled data from the KEYNOTE-010 and KEYNOTE-042 trials, presented at the European Society for Medical Oncology (ESMO) 2019 Congress (Abstract LBA79), tissue tumor mutational burden was found to be associated with survival outcomes in patients with advanced lung cancer who were treated with pembrolizumab monotherapy. “In this exploratory analysis, associations between higher tissue tumor mutational burden levels and improved clinical outcome with [pembrolizumab] monotherapy were observed in [patients] with PD-L1–positive [non–small cell lung cancer],” concluded Roy S. Herbst, MD, PhD, of the Yale University School of Medicine, and colleagues.

The study included 24% (n = 253) of patients in the KEYNOTE-010 trial and 62% (n = 793) of patients in the KEYNOTE-042 trial who were evaluable for tissue tumor mutational burden. The patient population included participants who had been treated with pembrolizumab monotherapy and those who had received chemotherapy alone. When data from tissue tumor mutational burden–evaluable patients were compared with those from the total study populations, tissue tumor mutational burden was not found to be associated with tumor proportion score in either treatment arm.

A correlation was observed between tissue tumor mutational burden and survival outcomes in patients treated with pembrolizumab monotherapy in both KEYNOTE-010 (1-sided P = .006 overall survival, .001 progression-free survival, and .009 objective response rate) and in KEYNOTE-042 (all 1-sided, P < .001). However, no such association was observed in the chemotherapy arm. In both KEYNOTE-101 and KEYNOTE-042, survival improvements were most commonly observed in patients with a tissue tumor mutational burden of at least 175 mut/exome who were receiving pembrolizumab.

Disclosure: For full disclosures of the study authors, visit

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