PharmaMar presenta nuevos resultados con lurbinectedina como agente único en pacientes con cáncer de pulmón microcítico recurrente en ASCO 2018 .
- Se trata del ensayo basket de fase II que comenzó reclutando 15 pacientes con cáncer de pulmón microcítico recurrente y que se ha ampliado a 100, tras obtenerse respuestas positivas.
- En un total de 61 pacientes ya analizados, se han observado respuestas en un 39,3%, con una mediana de duración de respuesta de 6,2 meses, y una mediana de supervivencia global de 12 meses.
- El objetivo principal del estudio es la tasa global de respuesta, con otros objetivos secundarios que incluyen la duración de respuesta, la supervivencia libre de progresión, la supervivencia global y el perfil de seguridad.
- “Los pacientes incluidos en este estudio con cáncer de pulmón microcítico están respondiendo favorablemente al tratamiento con lurbinectedina como agente único. Hemos observado que la molécula es activa en este grupo de pacientes, sin embargo tendremos más información una vez terminemos el reclutamiento y evaluemos a todos los pacientes”, explica el Dr. Arturo Soto, director del departamento de Clínica de la unidad de negocio de Oncología de PharmaMar.
Efficacy and Safety of Lurbinectedin (PM1183) in Small Cell Lung Cancer (SCLC) : Results from a Phase 2 Study.Sub-category : Small Cell Lung Cancer
Abstract No : 8570
Author(s) : Jose Manuel Trigo Perez, Alexandra Leary, Benjamin Besse, Daniel E. Castellano, Santiago Ponce Aix, Jennifer ARRONDEAU, Victor Moreno, Bernard Doger, Rafael Lopez, Ahmad Awada, Christiane Jungels, Martin David Forster, Valentina Boni, Pilar Lardelli, Mariano Siguero, Carmen Maria Kahatt, Arturo Soto-Matos, Rebecca Sophie Kristeleit; Hospital Virgen de la Victoria, Malaga, Spain; Gustave Roussy Cancer Campus, Villejuif, France; Gustave Roussy, Villejuif, France; Hospital 12 de Octubre, Madrid, Spain; Hôpital Cochin, Paris, France; START Madrid-FJD, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain; IDIS; CIBERONC,Hospital Clínico Universitario de Santiago de Compostela, Santiago De Compostela, Spain; Medical Oncology Clinic, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium; University College London Hospitals, London, United Kingdom; START Madrid-CIOCC, Hospital Universitario San Chinarro, Madrid, Spain; PharmaMar, Madrid, Spain
Abstract Disclosures
Abstract :
Background : SCLC is a deadly cancer and despite initial 80% response, almost all patients (pts) will relapse and die of this disease. Limited options exist after failure of first line, with a median time to progression (TTP) of around 3.5 months. New therapeutic agents are needed. Lurbinectedin (L) is a new anticancer drug that blocks transcription and induces DNA double-strand breaks, leading to apoptosis.
Methods : A multicenter phase 2 basket trial to assess the efficacy and safety of L in several types of advanced solid tumors, including SCLC, is ongoing. In the SCLC cohort, 15 adult patients without brain metastases, who had received one prior chemotherapy line, were recruited. If at least one confirmed response was observed, recruitment would be increased to 100 patients. The study intervention comprised L 3.2 mg/m2 in a 1-hour infusion every 3 weeks.
Results : 50 pts were treated and evaluable for efficacy. Median age was 60 years (range, 40-83) and 29 (58%) were males. 45 (80%) had an ECOG of 0/1. 34 pts (68%) had metastatic disease at study entry. 25 (50%) pts had a chemotherapy free interval (CTFI) ≥ 90 days and 22 (44%) had a CTFI < 90 days (unknown in 3). Pts received a median of 5 cycles of therapy (range, 1-18) and a median total dose of 15.9 mg/m2 (range, 2.9-58.2). Nineteen pts (38%) had a partial response (PR); among pts with CTFI ≥ 90 days, 52% (13/25) had a PR. Twenty pts (40%) had disease stabilization, 6 of them for > 4 months. Median response duration was (K-M) 5.3 (CI 95% 2.8-8.8) and median progression free survival (PFS) was 4.2 months (CI 95% 2.8-6.3). Median PFS for pts with CTFI ≥ 90 days was 4.7 months 95% CI (3.1-7.4). Myelosuppression was the most common adverse event: 44% neutropenia grade (G) 3/4, 12% febrile neutropenia, and 8% thrombocytopenia G 3/4; 8 pts had dose delay due to neutropenia G2-4, and 10 pts had dose reduced because of neutropenia G4. G-CSF was given to 9 pts. There was one protocol-defined withdrawal due to neutropenia.
Conclusions : Lurbinectedin as a single agent shows compelling activity as second line treatment in SCLC, with an acceptable tolerability and manageable safety profile. No unexpected or grade 5 toxicity occurred. Updated results will be presented.
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