KRASG12C/TP53 co-mutations identify long-term responders to first line palliative treatment with pembrolizumab monotherapy in PD-L1 high (≥50%) lung adenocarcinoma
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Background: Pembrolizumab is a standard of care as first line palliative therapy in PD-L1 overexpressing (≥50%) non-small cell lung cancer (NSCLC). This study aimed at the identification of KRAS and TP53-defined mutational subgroups in the PD-L1 high population to distinguish long-term responders from those with limited benefit. Methods: In this retrospective, observational study, patients from 4 certified lung cancer centers in Berlin, Germany, having received pembrolizumab monotherapy as first line palliative treatment for lung adenocarcinoma (LuAD) from 2017 to 2018, with PD-L1 expression status and targeted NGS data available, were evaluated. Results: A total of 119 patients were included. Rates for KRAS, TP53 and combined mutations were 52.1%, 47.1% and 21.9%, respectively, with no association given between KRAS and TP53 mutations (P=0.24). By trend, PD-L1 expression was higher in KRAS-positive patients (75% vs. 65%, P=0.13). Objective response rate (ORR), median progression-free survival (PFS) and overall survival (OS) in the KRASG12C group (n=32, 51.6%) were 63.3%, 19.8 months (mo.) and not estimable (NE), respectively. Results in KRASother and wild type patients were similar and by far lower (42.7%, P=0.06; 6.2 mo., P<0.001; 23.4 mo., P=0.08). TP53 mutations alone had no impact on response and survival. However, KRASG12C/TP53 co-mutations (n=12) defined a subset of long-term responders (ORR 100.0%, PFS 33.3 mo., OS NE). In contrast, patients with KRASother/TP53 mutations showed a dismal prognosis (ORR 27.3%, P=0.002; PFS 3.9 mo., P=0.001, OS 9.7 mo., P=0.02). Conclusions: A comprehensive assessment of KRAS subtypes and TP53 mutations allows a highly relevant prognostic differentiation of patients with metastatic, PD-L1 high LuAD treated upfront with pembrolizumab.
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Early data suggest KRAS alleles other than G12C, especially with TP53 co-mutation, may be negative predictive biomarkers for anti-PD-1/PD-L1 inhibitors in NSCLC.
“Early data suggests that the presence of KRAS alleles other than G12C mutations (75), especially in conjunction with a TP53 co-mutation, may represent a negative predictive biomarkers for anti-PD-1/PD-L1 immune checkpoint inhibitors in NSCLC patients (76).”
From Expanding the Reach of Precision Oncology by Drugging All <i>KRAS</i> Mutants (2022) · cites this paper as [75]
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- Authors
- Frost, N., Kollmeier, J., Vollbrecht, C., Grah, C., Matthes, B., Pultermann, D., von Laffert, M., Lüders, H., Olive, E., Raspe, M., Mairinger, T., Ochsenreither, S., Blum, T., Hummel, M., Suttorp, N., Witzenrath, M., & Grohé, C.
- Affiliations
- Humboldt-Universität zu Berlin (DE)
- Helios Klinikum Emil von Behring (DE)
- Gemeinschaftskrankenhaus Havelhöhe (DE)
- Evangelische Lungenklinik Berlin (DE)
- Corresponding author
- Frost, Nikolaj
- ORCID
- Venue
- Translational Lung Cancer Research
- Publisher
- AME Publishing Company
- Published
- 2021-02
- Volume
- 10
- Issue
- 2
- Pages
- 737-752
- ISSN
- 2218-6751 (ISSN-L)
- 2226-4477
- PMC
- PMC7947421
- OpenAlex
- W3134778331
- Cited by
- 61
- References
- 44
- Citations by year
- 2026: 10 · 2025: 10 · 2024: 12 · 2023: 8 · 2022: 18 · 2021: 3
- FWCI
- 6.63
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Licence
- cc-by-nc-nd
- Locations
- Translational Lung Cancer Research (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Refubium (Universitätsbibliothek der Freien Universität Berlin) (submittedVersion, cc-by-nc-nd)
- Universitätsbibliothek der FU Berlin Hochschulschriftenstelle u. Dokumentenserver
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- TP53 mutation, PD-L1 expression, lung adenocarcinoma, non-small cell lung cancer, predictive biomarkers, long-term response, objective response rate, progression-free survival, overall survival, immunotherapy response
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