Immune-related adverse events and clinical outcomes in patients with solid tumors treated with adebrelimab: a...

To investigate the association between treatment efficacy and immune-related adverse events (irAEs) in patients with solid malignancies receiving adebrelimab.

Clinical data from 46 patients with solid tumors who received adebrelimab between June 2023 and March 2026 were retrospectively collected. Patients were categorized as having experienced irAEs during treatment, and efficacy outcomes were compared between the irAE and non-irAE groups. Logistic regression analysis was used to evaluate the association between irAEs and objective response rate (ORR), whereas the Kaplan-Meier method, Cox regression, and time-dependent Cox models were used to assess the association between irAEs and progression-free survival (PFS).

Of the 46 patients, 40 (87.0%) experienced treatment-related adverse events (TRAEs), including 5 (10.9%) with grade 3-4 events. Eighteen patients (39.1%) experienced irAEs, most of which were grade 1-2, with a median onset time of 62 days (IQR, 42-163; range, 22-417 days). The overall ORR and disease control rate (DCR) were 37.0% and 87.0%, respectively. The ORR was higher in the irAE group than in the non-irAE group (61.1% vs. 21.4%, P = 0.012), whereas no significant difference in DCR was observed between the two groups (94.4% vs. 82.1%, P = 0.380). In univariate analysis, irAE occurrence was associated with ORR (OR = 5.762, 95% CI: 1.557-21.328; P = 0.009); however, after adjustment for the number of treatment cycles, this association did not reach statistical significance (OR = 3.847, 95% CI: 0.961-15.410; P = 0.057). Neither conventional Cox regression nor time-dependent Cox regression demonstrated a statistically significant association between irAE occurrence and PFS (HR = 1.906, 95% CI: 0.710-5.113, P = 0.200; HR = 2.444, 95% CI: 0.911-6.557, P = 0.076, respectively).

Adebrelimab demonstrated an overall acceptable and manageable safety profile, with most irAEs being low-grade. Although irAE occurrence was associated with a higher ORR, this association was attenuated after adjustment for the number of treatment cycles, and no significant association between irAEs and PFS was observed. The current findings are insufficient to support irAEs as an independent predictor of adebrelimab efficacy, and further validation in larger, multicenter, prospective studies is warranted.