HS-20093, a B7-H3-targeted antibody-drug conjugate in lung cancer: Results from the ARTEMIS-001 phase 1a/b trial

Clinical Snapshot

Key Findings

• P Value: Not reported in abstract

• Effect Size: Objective response rate: 52.3% (ES-SCLC) and 22.4% (NSCLC)

• Primary Outcome: Maximum tolerated dose established at 12.0 mg/kg, with 8.0 mg/kg selected for phase 3 development

• Nnt Or Sensitivity: Number needed to treat approximately 2 for ES-SCLC and 4-5 for NSCLC based on response rates

• Confidence Interval: ES-SCLC: 95% CI 39.5-64.9%; NSCLC: 95% CI 16.0-29.8%

Clinical Application

Requires specialized oncology centers with ADC administration experience and intensive monitoring capabilities Would require TGA approval and PBS listing consideration. Fits within current lung cancer treatment pathways for refractory disease, complementing existing immunotherapy and targeted therapy options Patients with previously treated advanced lung cancer, particularly extensive-stage SCLC where response rates were higher

Abstract

This phase 1a/b study (NCT05276609) evaluated the safety, pharmacokinetics, and efficacy of B7-H3-targeted antibody-drug conjugate HS-20093 (GSK5764227) in 306 patients with previously treated advanced solid tumors. In phase 1a, 12.0 mg/kg was established as the maximum tolerated dose. Among 236 lung cancer patients who received 8.0 or 10.0 mg/kg HS-20093, the most frequent grade ≥3 treatment-related adverse events (AEs) included decreased neutrophil (25.5% vs. 50.5%) and white blood cell counts (19.7% vs. 42.4%), and anemia (16.8% vs. 34.3%), respectively. Treatment-related interstitial lung disease and AEs leading to death occurred in 3.4% and 3.8% of patients, respectively. Among response-evaluable patients, the confirmed objective response rate was 52.3% (95% CI: 39.5, 64.9) for extensive-stage SCLC (ES-SCLC, N = 65) and 22.4% (95% CI: 16.0, 29.8) for non-small cell lung cancer (NSCLC, N = 152) patients, with comparable rates between 8.0 mg/kg and 10.0 mg/kg dose cohorts across both groups. These results support further development of HS-20093, with 8.0 mg/kg selected for phase 3 trials.

References

1. 1.Duan, J., Sun, Y., Wang, Q., Xing, L., Wu, L., Han, L., Chen, J., Liu, B., Lu, P., Shi, H., Yu, X., Zhang, J., Zhang, G., Hu, Y., Cheng, Y., Sun, H., Yang, H., Zhang, Z., Ning, F., He, Z., Yao, W., Dong, Y., Zhang, M., Song, B., Zhou, Y., Mao, X., Liu, Q., & Wang, J. (2026). HS-20093, a B7-H3-targeted antibody-drug conjugate in lung cancer: Results from the ARTEMIS-001 phase 1a/b trial. Cancer Cell. https://doi.org/10.1016/j.ccell.2026.02.006