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Baseline biomarkers of efficacy and on-treatment immune-profile changes associated with bempegaldesleukin plus nivolumab.
- Source :
- NPJ Precision Oncology; 7/19/2024, Vol. 8 Issue 1, p1-13, 13p
- Publication Year :
- 2024
-
Abstract
- In PIVOT IO 001 (NCT03635983), the combination of the investigational interleukin-2 agonist bempegaldesleukin (BEMPEG) with nivolumab (NIVO) had no added clinical benefit over NIVO monotherapy in unresectable/metastatic melanoma. Pre-defined baseline and on-treatment changes in selected biomarkers were analyzed to explore the potential mechanisms underlying the clinical observations. In each treatment arm, higher baseline tumor mutational burden or immune infiltration/inflammation was associated with improved efficacy compared with lower levels. On-treatment peripheral biomarker changes showed that BEMPEG + NIVO increased all immune cell subset counts interrogated, including regulatory T cells. This was followed by attenuation of the increase in CD8 + T cells, conventional CD4 + T cells, and systemic interferon gamma levels at later treatment cycles in the combination arm. Changes in tumor biomarkers were comparable between arms. These biomarker results help provide a better understanding of the mechanism of action of BEMPEG + NIVO and may help contextualize the clinical observations from PIVOT IO 001. [ABSTRACT FROM AUTHOR]
- Subjects :
- REGULATORY T cells
TUMOR markers
NIVOLUMAB
BIOMARKERS
T cells
Subjects
Details
- Language :
- English
- ISSN :
- 2397768X
- Volume :
- 8
- Issue :
- 1
- Database :
- Complementary Index
- Journal :
- NPJ Precision Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 178528227
- Full Text :
- https://doi.org/10.1038/s41698-024-00641-7