Sistema de Salut de Catalunya
Institut Català de la Salut
[Gogas H] National and Kapodistrian University of Athens, Athens, Greece. [Ravimohan S, Datta A, Chhibber A] Bristol Myers Squibb, Princeton, NJ, USA. [Muñoz Couselo E] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Diab A] MD Anderson Cancer Center, Houston, TX, USA
Vall d'Hebron Barcelona Hospital Campus
2024-07-29T11:35:45Z
2024-07-29T11:35:45Z
2024-07-19
Baseline biomarkers; Efficacy; Immune-profile
Biomarcadores basales; Eficacia; Perfil inmunológico
Biomarcadors basals; Eficàcia; Perfil immunològic
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.
Article
Published version
English
Quimioteràpia combinada; Medicaments antineoplàstics - Ús terapèutic; Melanoma - Tractament; CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents; DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Germ Cell and Embryonal::Neuroectodermal Tumors::Neuroendocrine Tumors::Melanoma; Other subheadings::Other subheadings::Other subheadings::/drug therapy; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols; CHEMICALS AND DRUGS::Biological Factors::Biomarkers; COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos; ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias de células germinales y embrionarias::tumores neuroectodérmicos::tumores neuroendocrinos::melanoma; Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada; COMPUESTOS QUÍMICOS Y DROGAS::factores biológicos::biomarcadores
Nature Portfolio
NPJ precision oncology;8(1)
https://doi.org/10.1038/s41698-024-00641-7
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
Articles científics - HVH [3427]
