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2024 World Conference on Lung Cancer (WCLC) - Post ...
P1.13A.07 Real-World First-Line Serplulimab-Based ...
P1.13A.07 Real-World First-Line Serplulimab-Based Immunochemotherapy for Extensive-Stage Small Cell Lung Cancer: The Multicenter ASTRUM-005R Study
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The interim analysis of the multicenter ASTRUM-005R study investigates the real-world efficacy and safety of serplulimab-based immunochemotherapy for patients with extensive-stage small-cell lung cancer (ES-SCLC) in China. This study follows the promising results of the phase III ASTRUM-005 study but is designed to address the need for real-world evidence due to the strict eligibility criteria of randomized controlled trials.<br /><br />Data from 538 patients across 14 Chinese institutions were included, with patients receiving at least two cycles of treatment. The primary endpoint was real-world progression-free survival (rwPFS), while secondary endpoints included overall survival (OS), objective response rate (ORR), and safety.<br /><br />Key findings highlight that the median rwPFS was 9.1 months. The 1-year rwPFS rate was 34.6%, and the 2-year rate was 11.3%. An impressive objective response rate of 71.29% was observed. Notably, patients without liver metastasis and those receiving more than four cycles of treatment had significantly higher rwPFS. The study also reports good tolerability, with 38.85% of patients experiencing adverse events of special interest (AESI), 15.43% of which were grade 3.<br /><br />The ASTRUM-005R study reaffirms the value of serplulimab plus chemotherapy in a real-world setting, demonstrating even better 1-year PFS rates compared to the initial ASTRUM-005 clinical trial. This study thus supplements the pivotal data of the phase III trial, providing critical real-world insights into the treatment's practical effectiveness and safety for a broader patient demographic with ES-SCLC.
Asset Subtitle
ChengPing Hu
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Speaker
ChengPing Hu
Topic
SCLC & Neuroendocrine Tumors
Keywords
ASTRUM-005R
serplulimab
immunochemotherapy
small-cell lung cancer
real-world efficacy
progression-free survival
objective response rate
adverse events
China
real-world evidence
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