TY - JOUR T1 - Nivolumab serum concentration in metastatic melanoma patients could be related to outcome and enhanced immune activity: a gene profiling retrospective analysis JF - Journal for ImmunoTherapy of Cancer JO - J Immunother Cancer DO - 10.1136/jitc-2022-005132 VL - 10 IS - 11 SP - e005132 AU - Domenico Mallardo AU - Diana Giannarelli AU - Maria Grazia Vitale AU - Domenico Galati AU - Giusy Trillò AU - Assunta Esposito AU - Maria Antonietta Isgrò AU - Grazia D'Angelo AU - Lucia Festino AU - Vito Vanella AU - Claudia Trojaniello AU - Andrew White AU - Teresa De Cristofaro AU - Michael Bailey AU - Sandro Pignata AU - Corrado Caracò AU - Antonella Petrillo AU - Paolo Muto AU - Piera Maiolino AU - Alfredo Budillon AU - Sarah Warren AU - Ernesta Cavalcanti AU - Paolo Antonio Ascierto Y1 - 2022/11/01 UR - http://jitc.bmj.com/content/10/11/e005132.abstract N2 - Background Nivolumab is an anti-PD-1 antibody approved for treating metastatic melanoma (MM), for which still limited evidence is available on the correlation between drug exposure and patient outcomes.Methods In this observational retrospective study, we assessed whether nivolumab concentration is associated with treatment response in 88 patients with MM and if the patient’s genetic profile plays a role in this association.Results We observed a statistically significant correlation between nivolumab serum concentration and clinical outcomes, measured as overall and progression-free survival. Moreover, patients who achieved a clinical or partial response tended to have higher levels of nivolumab than those who reached stable disease or had disease progression. However, the difference was not statistically significant. In particular, patients who reached a clinical response had a significantly higher concentration of nivolumab and presented a distinct genetic signature, with more marked activation of ICOS and other genes involved in effector T-cells mediated proinflammatory pathways.Conclusions In conclusion, these preliminary results show that in patients with MM, nivolumab concentration correlates with clinical outcomes and is associated with an increased expression of ICOS and other genes involved in the activation of T effectors cells.Data are available in a public, open access repository. ER -