Abstract 75P
Background
Adebrelimab is a novel humanised IgG4 monoclonal antibody against PD-L1, indicated for the first-line treatment of adult Patients with ES-SCLC in China. A registry study was conducted with the use of disease-specific database of lung cancer, at 21 Centres in Jiangsu, China. Here, we report results of Cohort ADBL-LC-001: the efficacy and safety of adebrelimab in the first-line treatment of patients with SCLC.
Methods
We prospectively collected medical records from patients with SCLC, who initiated first-line treatment with adebrelimab. Primary endpoint is progression-free survival (PFS) by RECIST 1.1, secondary endpoints included overall survival (OS), objective response rate (ORR) , disease control rate (DCR) and safety.
Results
Between March 2023 and March 2024, 143 patients were included, the median follow-up was 10.3 months. Overall, 114(80%) patients were ES-SCLC and 29(80%) LS-SCLC, median age was 67 years (rang, 34-84), and most patients were ≥65 years (62%), male (78%), with an ECOG score of one (90%). 29 (25%) patients with ES-SCLC had liver metastases, 23 (20%) had Brain metastases. In the group ES-SCLC, mOS was 12.4 months (95% CI, 10.0-14.9) and mPFS was 6.7 months (95% CI, 5.3-7.7), the ORR, DCR was 34.2%, 85.1%, respectively. In the group LS-SCLC, mOS was 15.4 months (95% CI, 13.7-NA) and mPFS was 14.6 months (95% CI, 13.4-15.4), the ORR, DCR was 51.7%, 96.6%, respectively. In the IIT population, TEAEs occurred in 136 (95.1%) patients, grade 3 or worse TEAEs occurred in 29 (20.3%) patients. The most common grade ≥ 3 TEAEs were neutrophil count decreased (8.4%), lymphocyte count decreased (5.6%), anemia (3.5%), white blood cell decreased (2.8%), γ-glutamyltransferase increased (2.8%). The safety profile was generally manageable, without any unexpected adverse events. Table: 75P
The most common adverse events (incidence>20%)
AEs, n(%) | ES-SCLC(N=114) | LS-SCLC(N=29) | Total(N=143) | |||
Any gade | Gade ≥ 3 | Any gade | Gade ≥ 3 | Any gade | Gade ≥ 3 | |
All gade | 110 (96.5%) | 26 (22.8%) | 26 (89.7%) | 3 (10.3%) | 136 (95.1%) | 29 (20.3%) |
Anemia | 74 (64.9%) | 4 (3.5%) | 21 (72.4%) | 1 (3.5%) | 95 (66.4%) | 5 (3.5%) |
Lymphocyte count decreased | 51 (44.7%) | 8 (7.0%) | 15 (51.7%) | 0 | 66 (46.2%) | 8 (5.6%) |
Hypoalbuminemia | 51 (44.7%) | 1 (0.8%) | 7 (24.1%) | 0 | 58 (40.6%) | 1 (0.7%) |
White blood cell decreased | 35 (30.7%) | 4 (3.5%) | 5 (17.2%) | 0 | 40 (28.0%) | 4 (2.8%) |
Nausea | 29 (25.4%) | 0 | 10 (34.5%) | 0 | 39 (27.3%) | 0 |
Neutrophil count decreased | 29 (25.4%) | 11 (9.7%) | 9 (31.0%) | 1 (3.5%) | 36 (25.2%) | 12 (8.4%) |
Fever | 13 (11.4%) | 0 | 10 (34.5%) | 0 | 13 (9.1%) | 0 |
Conclusions
This Real-world data verified the efficacy and safety of adebrelimab in the first-line treatment of patients with SCLC.
Legal entity responsible for the study
The authors.
Funding
Jiangsu Hengrui Pharmaceutical Co. LTD.
Disclosure
All authors have declared no conflicts of interest.
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