Lurbinectedin Plus Pembrolizumab in Relapsed SCLC: The Phase I/II LUPER Study
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| Názov: | Lurbinectedin Plus Pembrolizumab in Relapsed SCLC: The Phase I/II LUPER Study |
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| Autori: | Calles, Antonio, Doger de Speville Uribe, Bernard Gaston, Álvarez Colomé, Enric, de Miguel, María, NAVARRO, ALEJANDRO, ALVAREZ, ROSA, Rocha, Pedro, FELIP, ENRIQUETA |
| Prispievatelia: | Institut Català de la Salut, Calles A, Álvarez R Medical Oncology Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain. Navarro A Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Medica Scientia Innovation Research (MEDSIR), Barcelona (Spain), Ridgewood, New Jersey. Doger de Speville Uribe BG START Madrid-FJD, Hospital Fundación Jiménez Díaz, Madrid, Spain. Álvarez Colomé E, Rocha P, Felip E Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. de Miguel M START Madrid-CIOCC, Centro Integral Oncológico Clara Campal, Madrid, Spain, Vall d'Hebron Barcelona Hospital Campus |
| Zdroj: | Scientia |
| Informácie o vydavateľovi: | Elsevier |
| Rok vydania: | 2025 |
| Predmety: | Avaluació de resultats (Assistència sanitària), Pulmons - Càncer - Tractament, Anticossos monoclonals - Ús terapèutic, Quimioteràpia combinada, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome, DISEASES::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms::Bronchial Neoplasms::Carcinoma, Bronchogenic::Small Cell Lung Carcinoma, Other subheadings::Other subheadings::Other subheadings::/drug therapy, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols, CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Antibodies, Monoclonal, Humanized, Other subheadings::Other subheadings::/therapeutic use, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento, ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares::neoplasias de los bronquios::carcinoma broncogénico::carcinoma pulmonar de células pequeñas, Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada, COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::anticuerpos monoclonales humanizados, Otros calificadores::Otros calificadores::/uso terapéutico |
| Popis: | Lurbinectedin; Pembrolizumab; Platinum-sensitive ; Lurbinectedina; Pembrolizumab; Sensible al platino ; Lurbinectedina; Pembrolizumab; Sensible al platí ; 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/m2 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 ... |
| Druh dokumentu: | article in journal/newspaper |
| Popis súboru: | application/pdf |
| Jazyk: | English |
| Relation: | Journal of Thoracic Oncology;20(7); https://doi.org/10.1016/j.jtho.2025.02.005; Calles A, Navarro A, Doger Speville Uribe BG, Álvarez Colomé E, de Miguel M, Álvarez R, et al. Lurbinectedin plus pembrolizumab in relapsed small cell lung cancer (SCLC): the phase I/II LUPER study. J Thorac Oncol. 2025 Jul;20(7):969–82.; https://hdl.handle.net/11351/13720 |
| DOI: | 10.1016/j.jtho.2025.02.005 |
| Dostupnosť: | https://hdl.handle.net/11351/13720 https://doi.org/10.1016/j.jtho.2025.02.005 |
| Rights: | Attribution-NonCommercial-NoDerivatives 4.0 International ; http://creativecommons.org/licenses/by-nc-nd/4.0/ ; info:eu-repo/semantics/openAccess |
| Prístupové číslo: | edsbas.A81C0CB0 |
| Databáza: | BASE |
Nájsť tento článok vo Web of Science | Abstrakt: | Lurbinectedin; Pembrolizumab; Platinum-sensitive ; Lurbinectedina; Pembrolizumab; Sensible al platino ; Lurbinectedina; Pembrolizumab; Sensible al platí ; 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/m2 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 ... |
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| DOI: | 10.1016/j.jtho.2025.02.005 |