Jiménez-Aguilar, E. (Elisabeth)

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    Intratumoral nanoplexed poly I:C BO-112 in combination with systemic anti–PD-1 for patients with anti–PD-1–refractory tumors
    (2020) Longo, F. (Federico); Tersago, D. (Dominique); Ponce, S. (Santiago); Jove, M. (Maria); Calles, A. (Antonio); Sempere-Ortega, C. (Cayetano); Martín-Echarri, M. (Miguel); Soria, A. (Ainara); López-Tarruella, S. (Sara); Martin-Algarra, S. (Salvador); Rodriguez-Ruiz, M.E. (María Esperanza); Aznar, M.A. (María Ángela); Jiménez-Aguilar, E. (Elisabeth); Castañón-Álvarez, E. (Eduardo); Marquez-Rodas, I. (Iván); Alvarez, R. (Rosa); Calvo, A. (Aitana); Quintero, M. (Marisol); Ponz-Sarvise, M. (Mariano); Gómez-Rueda, A. (Ana); Lopez-Casas, P. (Pedro); Melero, I. (Ignacio); Rubio, B. (Belén); de Miguel, E. (Enrique); Gajate, P. (Pablo); Perez-García, J. (José); Ramos-Medina, R. (Rocío)
    Intratumoral therapies, especially Toll-like receptor agonists, can trigger both the innate and adaptive immune systems. BO-112 is a nanoplexed form of polyinosinic:polycytidylic acid (poly I:C) that induces local and systemic immunotherapeutic effects in mouse models. In a multicenter phase 1 clinical trial, repeated intratumoral administrations of BO-112 induced an increase in tumor cell necrosis and apoptosis, as well as augmented immune reactivity according to gene expression profiling. The first three cohorts receiving BO-112 as a monotherapy resulted in a recommended dose of 1 mg that could be safely repeated. Two grade 3 to 4 adverse reactions in the form of reversible thrombocytopenia were reported. In a fourth cohort of 28 patients with tumors that had primary resistance to anti–programmed cell death protein–1 (PD-1), the combination of intratumoral BO-112 with nivolumab or pembrolizumab was also well tolerated, and 3 patients (2 with melanoma and 1 with renal cell carcinoma) achieved partial responses, with 10 more patients having stable disease at 8 to 12 weeks. Thus, local BO-112 combined with a systemic anti–PD-1 agent might be a strategy to revert anti–PD-1 resistance