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Nat Commun ; 13(1): 3477, 2022 06 16.
Artigo em Inglês | MEDLINE | ID: mdl-35710741

RESUMO

PD-1 blockade (nivolumab) efficacy remains modest for metastatic sarcoma. In this paper, we present an open-label, non-randomized, non-comparative pilot study of bempegaldesleukin, a CD122-preferential interleukin-2 pathway agonist, with nivolumab in refractory sarcoma at Memorial Sloan Kettering/MD Anderson Cancer Centers (NCT03282344). We report on the primary outcome of objective response rate (ORR) and secondary endpoints of toxicity, clinical benefit, progression-free survival, overall survival, and durations of response/treatment. In 84 patients in 9 histotype cohorts, all patients experienced ≥1 adverse event and treatment-related adverse event; 1 death was possibly treatment-related. ORR was highest in angiosarcoma (3/8) and undifferentiated pleomorphic sarcoma (2/10), meeting predefined endpoints. Results of our exploratory investigation of predictive biomarkers show: CD8 + T cell infiltrates and PD-1 expression correlate with improved ORR; upregulation of immune-related pathways correlate with improved efficacy; Hedgehog pathway expression correlate with resistance. Exploration of this combination in selected sarcomas, and of Hedgehog signaling as a predictive biomarker, warrants further study in larger cohorts.


Assuntos
Antineoplásicos Imunológicos , Segunda Neoplasia Primária , Sarcoma , Antineoplásicos Imunológicos/uso terapêutico , Proteínas Hedgehog , Humanos , Interleucina-2/uso terapêutico , Segunda Neoplasia Primária/induzido quimicamente , Nivolumabe/uso terapêutico , Projetos Piloto , Receptor de Morte Celular Programada 1/metabolismo , Sarcoma/tratamento farmacológico , Sarcoma/patologia
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