Real-world study of adebrelimab for immune resumption after immune-related adverse events (irAEs).

Abstract

e23334 Background: "Management of Immunotherapy-Related Toxicities. NCCN Guidelines V2.2024" suggests considering restarting immunotherapy after resolution of some grade 2-3 irAEs to ≤ grade 1. Adebrelimab, a humanized PD-L1 inhibitor, demonstrates a favorable safety profile due to its unique structural optimization. In the real world, whether patients can continue to derive benefit from restarting immunotherapy after experiencing irAEs remains worthy of further exploration. Methods: This was a prospective, open-label, real-world study conducted across 83 hospitals in Jiangsu Province, China. Adult patients (≥18 years) with advanced solid tumors who developed irAEs during ICI treatment without disease progression were enrolled when irAEs resolved to ≤ grade 1. They received treatment based on adebrelimab. The primary endpoint was the 2-year survival rate. Secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response (DoR), objective response rate (ORR), and safety. Results: From April 16, 2025, to July 28, 2025, 141 patients were enrolled. Among them, 106 (75.18%) were male; the median age was 69 years (range, 40-93); 133 (94.33%) had an ECOG PS of 1; diagnoses included SCLC (30 patients, 21.28%), ESCC (26, 18.44%), NSCLC (22, 15.60%), and HCC (15, 10.64%); 118 patients (83.69%) were in second-line therapy; 131 patients (92.91%) had received anti-PD-1 therapy. At the data cutoff, the median duration of follow-up was 4.9 months (95% CI, 4.77-5.1). Treatment regimens included adebrelimab monotherapy (41 patients, 29.08%), combination with chemotherapy (68, 48.23%), combination with antiangiogenic agents (24, 17.02%), combination with antiangiogenic agents and chemotherapy (4, 2.84%), and combination with other therapies (4, 2.84%). The overall response rate(ORR) was 17.73%, with confirmed 1 (0.71%) complete response (CR) and 24 (17.02%) partial responses (PR). Stable disease (SD) was observed in 88 patients (62.41%), resulting in a disease control rate (DCR) of 80.14%. The median PFS was 5.23 months (95% CI, 5.2-NA). The median OS was not reached yet, the 6-month OS rate was 83% (95% CI, 75.9%-90.8%). After immune Resumption, the incidences of all-grade and grade ≥3 treatment-related adverse events (TRAEs) were 99.29% and 22.70%, respectively. Regarding irAEs post-resumption: 17.02% of patients experienced the same irAE, 17.73% experienced a different irAE, 2.84% experienced both the same and a different irAE, and 62.41% did not experience an irAE. The irAEs more likely to recur were rash, fatigue, and pneumonitis. Newly occurring irAEs included hepatotoxicity, thyroid dysfunction, fever, pneumonitis, and rash. Conclusions: Adebrelimab is safe and effective for immune resumption after irAEs. Clinical trial information: ChiCTR2500101774.