2026-04-17T01:29:17Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/117882025-10-24T10:24:03Zcom_2072_378070com_2072_378040col_2072_378092
RECERCAT
author
ravimohan, shruthi
author
Datta, Antara
author
Chhibber, Aparna
author
Tallón de Lara, Paulino
author
Gogas, Helen
author
MUÑOZ COUSELO, EVA
2025-10-24T10:24:03Z
2025-10-24T10:24:03Z
2024-07-29T11:35:45Z2024-07-29T11:35:45Z2024-07-19
http://hdl.handle.net/11351/11788
Baseline biomarkers; Efficacy; Immune-profileBiomarcadores basales; Eficacia; Perfil inmunológicoBiomarcadors basals; Eficàcia; Perfil immunològicIn 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.
Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess
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
Baseline biomarkers of efficacy and on-treatment immune-profile changes associated with bempegaldesleukin plus nivolumab
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion