Hansoh Pharma Initiates Phase 1b Trial of B7-H3 ADC HS-20093 in Combination Therapy for Osteosarcoma, Enrolling 448 Patients

▎Armstrong

On November 21, 2024, Hansoh Pharma registered a Phase 1b clinical trial on Clinicaltrials.gov for the B7H3 ADC new drug HS-20093 in combination therapy for osteosarcoma.

The Phase 1b Clinical Study of HS-20093 Combined immunotherapy (e.g., Adebrelimab) / vascular endothelial growth factor receptor tyrosine kinase inhibitor (e.g., Anlotinib Hydrochloride Capsules) with or without anthracyclines (e.g., Epirubicin) for the treatment of advanced bone and soft tissue sarcoma, planning to enroll 448 patients, with an expected preliminary completion by the end of 2026.

This Year's ASCO ConferenceAt the conference, Hansoh Pharma disclosed the latest Phase II clinical data of HS-20093 monotherapy for osteosarcoma. As of March 20, 2024, Cohort 1 (Patients with advanced osteosarcoma who have progressed after standard treatment) Enrolled 42 patients with osteosarcoma, with a median of 3 prior treatment lines. Among them, 35 patients (83.3%) had lung metastases, and 38 patients had at least one tumor assessment after baseline.The ORR of the 12.0mg/kg group was 17.4%, with the median progression-free survival (PFS) not reached; the median PFS of the 8mg/kg group was 4.0 months.Cohort 2 (Patients with bone and soft tissue sarcoma that is inoperable, lacks standard treatment options, or has failed/intolerant to standard treatment.) A total of 20 patients with osteosarcoma were enrolled, with a median of 3 prior treatment lines. Among them, 18 patients (90%) had lung metastases, and all 20 patients with other bone and soft tissue sarcomas were evaluable for efficacy.ORR was 25%, with a median PFS of 7.1 months.In terms of safety, common Grade ≥3 adverse events (incidence rate ≥10%) included decreased neutrophil count, decreased white blood cell count, decreased lymphocyte count, decreased platelet count, and anemia.

Summary

Hansoh Pharma has identified osteosarcoma as another significant breakthrough for its B7H3 ADC, which had already received Breakthrough Therapy Designation for small cell lung cancer. Meanwhile, Yilian Biologics' B7H3 ADC, following its progress in small cell lung cancer, has demonstrated excellent efficacy data in nasopharyngeal carcinoma.