Baseline biomarkers of efficacy and on-treatment immune-profile changes associated with bempegaldesleukin plus nivolumab
- Author(s)
- Gogas, H; Ravimohan, S; Datta, A; Chhibber, A; Couselo, EM; Diab, A; Pereira, C; Quéreux, G; Sandhu, S; Curti, B; Khushalani, NI; Taylor, MH; Daniels, GA; Spreafico, A; Meniawy, T; van den Eertwegh, AJM; Sun, Y; Arriaga, Y; Zhou, M; Long, GV; Lebbé, C;
- Details
- Publication Year 2024-07-19,Volume 8,Issue #1,Page 150
- Journal Title
- NPJ Precision Oncology
- Publication Type
- Research article
- 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.
- Publisher
- Springer Nature
- Department(s)
- Medical Oncology
- Publisher's Version
- https://doi.org/10.1038/s41698-024-00641-7
- Open Access at Publisher's Site
https://doi.org/10.1038/s41698-024-00641-7- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2024-08-29 04:13:44
Last Modified: 2024-08-29 04:22:13