Multicenter phase 1a/b trial of HS-20093, a B7-H3 targeted antibody-drug conjugate, for non-small cell and small cell lung cancer

The multicenter phase 1a/b ARTEMIS-001 study in China evaluated the B7-H3-targeted antibody-drug conjugated HS-20093 in 306 patients with previously treated advanced solid tumors. In phase 1a (n=53), 12.0 mg/kg once every three weeks 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 included decreased neutrophil (25.5% and 50.5%) and white blood cell counts (19.7% and 42.4%) and anemia (16.8% and 34.3%), respectively. Treatment-related interstitial lung disease occurred in 3.4% of patients and TRAEs leading to death in 3.8%. Among response-evaluable patients, the confirmed objective response rate was 52.3% (95% CI 39.5-64.9) for extensive-stage small cell lung cancer (n=65) and 22.4% (16.0-29.8) for non-small lung cancer (n=152), with comparable rates between 8.0 mg/kg and 10.0 mg/kg dose cohorts across both groups. The authors conclude that these results support further development of HS-20093, with 8.0 mg/kg selected for phase 3 trials.