HS-20093 shows response in lung cancers in Phase 1a/b trial

This Phase 1a/b trial evaluated HS-20093, a B7-H3-targeted antibody-drug conjugate, in 306 patients with previously treated advanced solid tumors, including lung cancers. The intervention was HS-20093 at doses of 8.0 mg/kg or 10.0 mg/kg, with no comparator reported. The primary outcomes were safety, pharmacokinetics, and efficacy, with a follow-up duration not reported.

For efficacy, the confirmed objective response rate was 52.3% (95% CI: 39.5, 64.9) in extensive-stage small cell lung cancer (N = 65) and 22.4% (95% CI: 16.0, 29.8) in non-small cell lung cancer (N = 152). Effect sizes and direction were not reported. The maximum tolerated dose was established at 12.0 mg/kg.

Safety data showed adverse events including decreased neutrophil counts (25.5% vs. 50.5%), decreased white blood cell counts (19.7% vs. 42.4%), anemia (16.8% vs. 34.3%), treatment-related interstitial lung disease (3.4%), and adverse events leading to death (3.8%). Serious adverse events included treatment-related interstitial lung disease (3.4%), with discontinuations not reported. Limitations were not specified, and funding or conflicts were not reported.

Practice relevance is limited as this is an early-phase trial; the 8.0 mg/kg dose was selected for Phase 3 trials, but results should be interpreted with caution due to the lack of a comparator and incomplete safety reporting.