ASCO24 . POSTER 8094 : PHASE II Efficacy And Safety Of LURBINECTEDIN With IRINOTECAN in Patients With RELAPSED SMALL CELL LUNG CÁNCER ( SEGUNDA LÍNEA ) . PFS : 5,6 MESES . OS : 12,7 MESES . Treatment-Related Adverse Events (AEs) Were Observed in 99.0% of Patients ( Grade ≥3 in 69.3% ) .

 

Se Ha Echado en Falta Uno de los Principales Científicos Que Han Llevado a Cabo Dicho Ensayo Clínico ... ALI ZEAITER .

 En ASCO 2024 el POSTER Más Destacado Que Ha Presentado PharmaMar ... Es el 8094 con los Datos de FASE II de la Combinación entre LURBINECTEDIN y IRINOTECAN ... 

No Hubo Presentación Oral ... 

Y Nada se Presentó  Sobre las Fases III LAGOON NI IMFORTE .

Poster Numero 8094 Presentado Por PHARMAMAR en ASCO24 con Resultados de la FASE I-II en Pacientes con Cáncer de Pulmón Microcítico en Segunda Línea con la Combinación entre LURBINECTEDIN y IRINOTECAN ( PM1183-A-014-15 ) : 

The PHASE 1b/2 study PM1183-A-014-15 (NCT02611024) evaluated the LUR/IRI combination in pretreated pts with advanced solid tumors . The phase 1b part defined the recommended dose at LUR 2.0 mg/m2 on Day (D)1 + IRI 75 mg/m2 on D1,D8 every three weeks with primary G-CSF prophylaxis, and found promising results for the combination in SCLC pts after first-line therapy (Ponce Aix S. Ann Oncol 2019; 30: Abst 471P) .Methods :Eligibility criteria for this cohort of the phase 2 part of this study included : Confirmed SCLC, progression after one platinum-containing regimen, controlled brain metastases and ECOG PS ≤ 1. The primary endpoint was overall response rate (ORR).Results :101 Evaluable pts Were Enrolled . Baseline characteristics included: median age 63 (range, 45-77 y), 60.4% males, 76.2% ECOG PS 1, 28.7% CNS involvement, 39.6% bulky disease and 41.6% pretreated with immunotherapy . Chemotherapy-free interval (CTFI) was <90 d in 51.4% of pts (26.7% had CTFI<30 d. Median CTFI was 85 d (range, 0-323 d). Median number of cycles per pt was 6 (range, 1-34); 25.7% received >10 cycles. Efficacy results by independent review committee are summarized in the table .

Treatment-Related Adverse Events (AEs) Were Observed in 99.0% of Patients ( Grade ≥3 in 69.3% ).

 Most relevant grade ≥3 events/abnormalities were neutropenia (52.5%), anemia (27.7%), diarrhea (19.8%), fatigue (18.8%), and febrile neutropenia (9.9%). Treatment-related SAEs occurred in 25.0% of pts and 5.0% discontinued due to treatment-related AEs. No treatment-related deaths occurred .Conclusions :The LUR/IRI combination showed promising antitumor activity and a manageable safety profile in these pts with poor prognosis, Particularly Those With CTFI>30 d.