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9.2 Anticorpi anti-PD-1 e anti-PD-L1

9.2.3 BMS-936559

BMS-936559 è un anticorpo completamente umano della classe delle immunoglobuline G4 (IgG4), diretto su PD-L1; è stato testato in 55 pazienti con melanoma metastatico, che costituivano una parte di tutti coloro che sono stati sottoposti ad uno studio di fase I [Brahmer, et al, 2012]. Il 56% dei pazienti era stato trattato, in precedenza, con immunoterapia e il 9% aveva ricevuto, in passato, la terapia con gli inibitori di BRAF. Le infusioni di BMS-936559 sono state eseguite ogni 2 settimane. Il tasso di risposta globale è stato pari al 17% ed è variato tra il 6% e il 29% all’interno dell’intervallo di dosaggio pari a 0,3-10 mg/kg. In particolar modo, il tasso di risposta più elevato è stato osservato alla dose di 3 mg/kg. Il 27% dei pazienti, trattati con l’anticorpo in esame, ha presentato la malattia stabile per oltre 6 mesi. Le tossicità sono state generalmente lievi e gestibili. All’interno del gruppo totale di pazienti esaminati, il 9% ha manifestato tossicità di grado 3 e il 39% ha avuto reazioni avverse immunitarie di qualsiasi grado, che hanno incluso rash, ipotiroidismo, epatite, sarcoidosi, endoftalmite, diabete mellito e miastenia grave.

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