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PIIS1556086425000644.pdf (1.1 MB)

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2025-02-10

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cc by-nc-nd (c) Calles Blanco, Antonio et al, 2025
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/223147

Lurbinectedin Plus Pembrolizumab in Relapsed SCLC: The Phase I/II LUPER Study

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https://doi.org/10.1016/j.jtho.2025.02.005

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Introduction: SCLC has limited second-line treatment options after chemotherapy. We assessed the efficacy and safety of lurbinectedin combined with pembrolizumab in relapsed SCLC patients who had not received prior immunotherapy, aiming to prevent early progression and achieve sustained responses. Methods: The LUPER trial (NCT04358237) is a phase I/II, single-arm, open-label, multicenter study. Phase I established the recommended phase II dose. The primary endpoint of phase II was the investigator-confirmed objective response rate. Secondary endpoints included duration of response, progression-free survival (PFS), overall survival (OS), and safety. Patients were categorized as platinum-sensitive (chemotherapy-free interval >= 90 d) or platinum-resistant (<90 d). Results: The recommended phase II dose was 3.2 mg/m(2) lurbinectedin and 200 mg pembrolizumab IV every three weeks. Phase II included 28 patients, 50% of whom were platinum-resistant. The objective response rate was 46.4% (95% confidence interval: 27.5-66.1, p < 0.001), including three complete responses, with two complete metabolic responses post-treatment completion at 35 cycles. The median duration of response was 7.8 months, with 40% of patients maintaining responses for 12 months or longer. The median PFS was 4.6 months, and the median OS was 10.5 months. Platinum-sensitive patients had significantly better PFS (8.0 versus 2.8 mo, p = 0.012) and numerically superior OS (15.7 versus 7.1 mo, p = 0.058). Grade 3 or higher treatment-related adverse events occurred in 71.4% of patients, with transient neutropenia being the most common. Immune-related adverse events were consistent with prior pembrolizumab studies. Conclusions: Lurbinectedin plus pembrolizumab reported promising efficacy in relapsed SCLC, particularly for platinum-sensitive patients, with a known and manageable safety profile. These results support further exploration of this combination in SCLC treatment.

Matèries

Leucèmia limfocítica crònica, Anticossos monoclonals

Matèries (anglès)

Chronic lymphocytic leukemia, Monoclonal antibodies

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Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

Citació

CALLES BLANCO, Antonio, NAVARRO, Alejandro, DOGER DE SPEVILLE URIBE, Bernard gaston, ÁLVAREZ COLOMÉ, Enric, MIGUEL, María de, ÁLVAREZ, Rosa, ARREGUI, Marta, MORENO, Víctor, ROCHA, Pedro, CALVO, Emiliano, RAMON PATINO, Jorge, CORRAL DE LA FUENTE, Elena, ALCALÁ LÓPEZ, Daniel, BOIX, Olga, FERNÁNDEZ PINTO, Melissa, RODRÍGUEZ MORATÓ, Jose, PALMERO, Ramón, NADAL, Ernest, JOVE, Maria, FELIP, Enriqueta. Lurbinectedin Plus Pembrolizumab in Relapsed SCLC: The Phase I/II LUPER Study. _Journal of Thoracic Oncology_. 2025. Vol. 20, núm. 7, pàgs. 969-982. [consulta: 24 de gener de 2026]. [Disponible a: https://hdl.handle.net/2445/223147]

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