Early plasma circulating tumor DNA (ctDNA) changes predict response to first-line pembrolizumab-based therapy in non–small cell lung cancer (NSCLC)
Open accessAbstract
Background: Currently available biomarkers are imperfect in their ability to predict responses to the multiple first-line treatment options available for patients with advanced non-small cell lung cancer (NSCLC). Having an early pharmacodynamic marker of treatment resistance may help redirect patients onto more effective alternative therapies. We sought to determine if changes in circulating tumor DNA (ctDNA) levels after initiation of first-line pembrolizumab±chemotherapy in NSCLC would enable early prediction of response prior to radiological assessment. Methods: Plasma collected from patients with advanced NSCLC prior to and serially after starting first-line pembrolizumab±platinum doublet chemotherapy was analyzed by next-generation sequencing using enhanced tagged-amplicon sequencing of hotspots and coding regions from 36 genes. Early change in ctDNA allele fraction (AF) was correlated with radiographic responses and long-term clinical outcomes. Results: Among 62 patients who received first-line pembrolizumab±platinum/pemetrexed and underwent ctDNA assessment, 45 had detectable ctDNA alterations at baseline. The median change in AF at the first follow-up (at a median of 21 days after treatment initiation) was −90.1% (range −100% to +65%) among patients who subsequently had a radiologic response (n=18), –19.9% (range: −100% to +1884%) among stable disease cases (n=15), and +28.8% (range: −100% to +410%) among progressive disease cases (n=12); p=0.003. In addition, there was a significant correlation between the percent change in ctDNA at the first follow-up and the percent change in tumor target lesions from baseline (R=0.66, p<0.001). AF decrease between the pretreatment and first on-treatment blood draw was associated with significantly higher response rate (60.7% vs 5.8%, p=0.0003), and significantly longer median progression-free survival (8.3 vs 3.4 months, HR: 0.29 (95% CI: 0.14 to 0.60), p=0.0007) and median overall survival (26.2 vs 13.2 months, HR: 0.34 (95% CI: 0.15 to 0.75), p=0.008) compared with cases with an AF increase. Conclusion: In patients with advanced NSCLC, rapid decreases in ctDNA prior to radiological assessment correlated with clinical benefit. These results suggest a potential role for ctDNA as an early pharmacodynamic biomarker of response or resistance to immunotherapies.
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Recent data suggest that serial ctDNA analyses may have clinical value because ctDNA clearance in patients receiving systemic chemo- or immunotherapy correlates with progression-free and overall survival.
“recent data suggests that serial analyses may have clinical value as clearance of ctDNA among patients undergoing systemic chemo- or immunotherapy correlate with progression-free and overall survival.13–17”
From Early Changes in Circulating Cell-Free <i>KRAS</i> G12C Predict Response to Adagrasib in KRAS Mutant Non–Small Cell Lung Cancer Patients (2023) · cites this paper as [15]
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- Authors
- Ricciuti, B., Jones, G., Severgnini, M., Alessi, J. V., Recondo, G., Lawrence, M., Forshew, T., Lydon, C., Nishino, M., Cheng, M., & Awad, M.
- Affiliations
- Dana-Farber Cancer Institute (US)
- Inivata, Research Triangle Park, North Carolina, USA
- Brigham and Women's Hospital (US)
- Corresponding author
- Awad, Mark
- ORCID
- Venue
- Journal for ImmunoTherapy of Cancer
- Publisher
- BMJ
- Published
- 2021-03
- Volume
- 9
- Issue
- 3
- Pages
- e001504
- ISSN
- 2051-1426 (ISSN-L)
- PMC
- PMC7996662
- OpenAlex
- W3139130539
- Cited by
- 161
- References
- 30
- Citations by year
- 2026: 24 · 2025: 33 · 2024: 32 · 2023: 36 · 2022: 27 · 2021: 9
- FWCI
- 16.82
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Journal for ImmunoTherapy of Cancer (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- National Cancer Institute (R01CA203636)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- circulating tumor DNA, liquid biopsy, pembrolizumab, non-small cell lung cancer, first-line immunotherapy, predictive biomarkers, pharmacodynamic biomarkers, treatment response prediction, platinum-based chemotherapy, pemetrexed, progression-free survival, overall survival, treatment resistance, immune checkpoint inhibitors, tumor mutational burden, PD-L1
- MeSH terms
- Circulating Tumor DNA, Progression-Free Survival, Immune Checkpoint Inhibitors, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Predictive Value of Tests, Retrospective Studies, Time Factors, Biomarkers, Tumor, Disease Progression, Early Diagnosis, Antibodies, Monoclonal, Humanized
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