- Efficacy and Safety of Lurbinectedin for Small Cell Lung Cancer in a Real-World Setting: Jazz EMERGE 402 Study
Introduction: Lurbinectedin monotherapy is approved in many countries, including the United States (US) and Canada for adults with metastatic (US) or stage 3/metastatic (Canada) small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. The Jazz EMERGE 402 phase 4 trial is assessing the real-world efficacy and safety of lurbinectedin for patients with extensive stage (ES)-SCLC. Preliminary safety data from this study were previously presented. For the first time, we report efficacy results along with updated safety data .
Methods: This observational, multicenter, single-arm study (NCT04894591) is enrolling patients with ES‑SCLC according to local approved labels, in the US and Canada .
Results: As of 02Jan2024, 171 patients had received ≥1 cycle of lurbinectedin; 13 (8%) had ongoing treatment and 158 (92%) discontinued with disease progression being the most common reason (n=104 [66%]). The median (range) age was 67 (29-89) years; 37 (22%) patients had an Eastern Cooperative Oncology Group performance status (ECOG PS) of ≥2; and 35 (20%) had central nervous system (CNS) involvement. Baseline characteristics were broadly similar between patients with a chemotherapy free interval (CTFI)<90 days vs ≥90 days. Ninety-two (54%) patients received lurbinectedin monotherapy as second-line (2L) and 59 (35%) as third-line. Median (range) number of lurbinectedin cycles was 4 (1-31) and duration of exposure was 105 (21-694) days
Results: As of 02Jan2024, 171 patients had received ≥1 cycle of lurbinectedin; 13 (8%) had ongoing treatment and 158 (92%) discontinued with disease progression being the most common reason (n=104 [66%]). The median (range) age was 67 (29-89) years; 37 (22%) patients had an Eastern Cooperative Oncology Group performance status (ECOG PS) of ≥2; and 35 (20%) had central nervous system (CNS) involvement. Baseline characteristics were broadly similar between patients with a chemotherapy free interval (CTFI)<90 days vs ≥90 days. Ninety-two (54%) patients received lurbinectedin monotherapy as second-line (2L) and 59 (35%) as third-line. Median (range) number of lurbinectedin cycles was 4 (1-31) and duration of exposure was 105 (21-694) days .
Conclusiones : Jazz EMERGE 402 ha inscrito una población de pacientes de SCLC más amplia y más enferma que el ensayo de fase 2 que condujo a la aprobación de lurbinectedina .
Los pacientes con CTFI <90 o ≥90 días que recibieron lurbinectedina en 2 litros mostraron una ORR, mPFS y mOS más altas que en líneas posteriores, y mostraron mOS y mPFS comparables a los del ensayo de canasta. El perfil de seguridad de lurbinectedina en el mundo real se hizo eco de informes anteriores, sin nuevas señales de seguridad .