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2023 World Conference on Lung Cancer (Posters)
P2.17. Real-world Safety and Dosing of Lurbinected ...
P2.17. Real-world Safety and Dosing of Lurbinectedin-Treated Patients with Small Cell Lung Cancer: Jazz EMERGE 402 Preliminary Analysis - PDF(Slides)
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The preliminary analysis of the Jazz EMERGE 402 study evaluated the real-world safety and dosing of lurbinectedin in patients with small cell lung cancer (SCLC) who had previously received treatment. Lurbinectedin is an approved monotherapy for relapsed SCLC based on its overall response rate and duration of response observed in a phase 2 trial.<br /><br />The ongoing phase 4 study enrolled 103 adult patients with SCLC who had received one prior platinum-based chemotherapy regimen. The study aimed to assess the real-world effectiveness and safety of lurbinectedin in a broader SCLC population. The patients were assessed by physicians and prescribed lurbinectedin according to local prescribing information.<br /><br />The results showed that lurbinectedin was generally well-tolerated in this real-world setting, with low rates of dose modifications and treatment discontinuation due to adverse events. Most patients received the full dose without dose adjustments. Prophylactic use of granulocyte colony-stimulating factor (G-CSF) may have contributed to the low rates of febrile neutropenia reported.<br /><br />The safety profile of lurbinectedin in this analysis was consistent with the findings from the phase 2 trial, and no new safety signals were identified. There were no reported incidences of treatment-related febrile neutropenia, and patients who received G-CSF had similar rates of dose delays and reductions compared to those who did not.<br /><br />Approximately one-third of patients in the study were still receiving lurbinectedin at the time of data extraction. The median number of treatment cycles administered was 3, with a median duration of treatment exposure of 81.0 days.<br /><br />Overall, the preliminary analysis suggests that lurbinectedin is well-tolerated and effective in a real-world setting for patients with SCLC who have received prior treatment. The ongoing Jazz EMERGE 402 study aims to provide further insights into the real-world effectiveness and safety of lurbinectedin in a broader population of SCLC patients.
Asset Subtitle
Balazs Halmos
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Speaker
Balazs Halmos
Topic
SCLC & Neuroendocrine Tumors: Relapse & Salvage Therapy
Keywords
Jazz EMERGE 402 study
lurbinectedin
small cell lung cancer
real-world safety
real-world dosing
monotherapy
relapsed SCLC
phase 2 trial
phase 4 study
platinum-based chemotherapy regimen
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