Frontline Adebrelimab Shows Promise in Real-World ES-SCLC Treatment

"These data support adebrelimab’s role in real-world ES-SCLC management while highlighting the critical need for biomarker-driven strategies," according to the study authors.

The real-world use of adebrelimab (Ariely) demonstrated promising efficacy among a small cohort of patients with extensive-stage small cell lung cancer (ES-SCLC), according to data from a retrospective study published in Frontiers.1

After a median follow-up of 18.5 months (IQR, 12.3-24.1) among 35 evaluable patients, the objective response rate (ORR) was 62.8%, which consisted entirely of partial responses (PRs). Additionally, 14.3% of patients experienced stable disease, yielding a disease control rate (DCR) of 77.1%.

Data showed a median overall survival (OS) of 15.0 months (95% CI, 10.47-19.53). Adebrelimab also produced a median progression-free survival (PFS) of 7.1 months (95% CI, 5.47-8.53).

Per univariate analyses, risk factors correlating with worse PFS outcomes included having 2 or more metastatic organs vs fewer than 2 (HR, 3.463; 95% CI, 1.474-8.134; P = .004), an ECOG performance status of 2 vs 0 or 1 (HR,19.657; 95% CI, 3.462-111.600; P = .001), and a lactate dehydrogenase (LDH) of 250 or higher vs lower than 250 (HR, 2.966; 95% CI, 1.325-6.637; P = .008). Potential risk factors for worse OS included having 2 or more metastatic organs (HR, 4.501; 95% CI, 1.613-12.558; P = .004), an ECOG performance status of 2 (HR, 10.938; 95% CI, 2.636-45.380; P = .001), and a C-reactive Protein score of 5 or higher vs lower than 5 (HR, 3.171; 95% CI, 1.146-8.775; P = .026).

Multivariate analysis showed that a higher ECOG performance status (HR, 9.446; 95% CI, 1.596-56.151; P = .013) significantly correlated with PFS outcomes. Additionally, having CRP levels of 5 or higher (HR, 3.337; 95% CI, 1.034-10.768; P = .044) and 2 or more metastatic organs (HR, 3.594; 95% CI, 1.020-12.657; P = .046) correlated with worse OS.

“This study suggests potential real-world effectiveness of first-line adebrelimab in ES-SCLC, achieving survival benchmarks set by [randomized clinical trials] despite [an] older, comorbid [population]. ECOG [performance status of 2 or higher], metastatic burden [in 2 or more] organs, and elevated CRP/LDH identify high-risk subgroups needing tailored approaches,” lead study author Kaili Xu, from the Department of Pulmonary and Critical Care Medicine of The Quzhou Affiliated Hospital of Wenzhou Medical University at Quzhou People′s Hospital in Quzhou, Zhejiang, China, wrote with coauthors in the publication.1 “The safety profile remains manageable, though hematologic toxicity and rare cardiotoxicity necessitate vigilant monitoring. These data support adebrelimab’s role in real-world ES-SCLC management while highlighting the critical need for biomarker-driven strategies.”

Previously, adebrelimab, when combined with carboplatin/etoposide, significantly improved PFS and OS vs chemotherapy alone among patients with ES-SCLC in the phase 3 CAPSTONE-1 trial (NCT03711305), which supported the regimen’s approval in China.2 Despite studies like CAPSTONE-1 establishing the role of PD-L1 inhibitors in the management of ES-SCLC, the study authors noted a scarcity of real-world data focusing on adebrelimab in the frontline setting.

Investigators of this retrospective study collected data from the electronic medical record system on 35 patients with ES-SCLC who received first-line adebrelimab. Patients underwent treatment with adebrelimab and chemotherapy at Quzhou People’s Hospital from September 2021 to March 2025.

Those with histologically or cytologically confirmed ES-SCLC, adequate hepatic and renal function, receipt of a frontline treatment regimen including adebrelimab, and at least 1 measurable lesion were included in the analysis. Patients with a history of autoimmune disease, an ECOG performance status of more than 2, pregnancy, and multiple primary malignant neoplasms were ineligible for inclusion. Study end points included ORR, DCR, PFS, OS, and adverse effects (AEs).

The median age was 72 years (range, 52-87), and most patients were male (88.6%) and currently smoking (48.6%). Additionally, most patients had 2 or more metastatic organs (51.4%), an ECOG performance status of 0 or 1 (85.7%), and chemotherapy with etoposide/cisplatin (51.4%).

Subgroup analyses showed that independent risk factors for worse PFS and OS, respectively, included higher performance statuses (P <.001; P <.001), higher metastatic burden (P = .001; P = .002), and higher LDH levels (P = .001; P = .014).

The most common grade 1/2 AEs included anemia (85.7%), fatigue (74.3%), thrombocytopenia (42.9%), and nausea (34.3%). Grade 3/4 toxicities consisted of neutropenia (51.4%), thrombocytopenia (20.0%), liver impairment (14.3%), anemia (14.3%), fatigue (8.6%), and elevated creatinine (2.9%). Investigators observed no grade 5 AEs in the study.

References

1. Xu K, Wang J, Weng Z, Wang J, Chen J. Real-world study of adebrelimab as first-line therapy for extensive-stage small cell lung cancer: a retrospective study. Front Immunol. 2025;16:1678020. doi:10.3389/fimmu.2025.1678020
2. Wang J, Zhou C, Yao W, et al. Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022;23(6):739-747. doi:10.1016/S1470-2045(22)00224-8