Hansoh Pharma Presents Phase 2 Data of B7-H3-Targeted ADC HS-20093 in Relapsed/Refractory Osteosarcoma at ASCO 2024 Oral Session

May 25, 2024 08:50 CST Updated 08:51

Hansoh Pharma

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The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting will be held in Chicago, USA, from May 31 to June 4 (local time). According to the abstract on the ASCO official website, Hansoh Pharma has developedAntibody-Drug Conjugates (ADC) Targeting B7-H3Treatment of Recurrent/Refractory Osteosarcoma PatientsThe Phase 2 study was selected for the oral presentation session. The data showed:Patient'sObjective Response Rate (ORR)Is 20.0%；Patients in the 8 mg/kg groupThe disease control rate (DCR) was 81.8%.Patients in the 12.0 mg/kg groupThe DCR is100%。

Osteosarcoma predominantly occurs in children and young adults. Patients with relapsed/refractory (R/R) osteosarcoma typically have a poor prognosis and limited treatment options. B7-H3 is an emerging anticancer target that has garnered significant attention in recent years. As a transmembrane protein of the B7 family, B7-H3 is frequently overexpressed in various cancers. Studies indicate that inhibitors targeting B7-H3, including antibodies, ADCs, and radioimmunotherapy, represent a new class of antitumor drugs.

HS-20093 is a novel ADC targeting B7-H3 developed by Hansoh Pharma. It consists of a humanized anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor (TOPOi) payload. In December 2023,GSK once reached a collaboration worth over $1.7 billion with Hansoh Pharma, obtaining the development, production, and commercialization rights for the drug in all other global regions outside of Greater China (including mainland China, Hong Kong, Macao, and Taiwan).

At this year's ASCO conference, Hansoh Pharma presented the phase 2 trial ARTEMIS-002 research data on HS-20093 for the treatment of patients with recurrent/refractory osteosarcoma.Previously, the drugHas demonstrated preliminary anti-tumor activity in the Phase 1 clinical study ARTEMIS-001.Based on the results of the Phase 1 clinical trial, the maximum tolerated dose for patients is 12mg/kg, administered once every three weeks (Q3W) via intravenous infusion. Osteosarcoma patients in the Phase 2 trial were randomized to receive 8 mg/kg.HS-20093or 12 mg/kgHS-20093 ‍Q3W, with an enrollment ratio of 1:1. The primary endpoint of the study is the objective response rate (ORR) according to RECIST 1.1.

From June to December 2023, a total of 34Relapsed/RefractoryPatients with osteosarcoma were enrolled to receive HS-20093 at a dose of 8.0 mg/kg (N=15) or 12.0 mg/kg (N=19). At baseline, most patients were assessed as having clinical stage IV disease and lung metastases. Among them, 22 patients (64.7%) had received ≥3 prior treatments. A total of 26 patients (76.5%) received four standard chemotherapies, including platinum, anthracycline, ifosfamide, and methotrexate.

As of the data cutoff date (December 25, 2023), the median follow-up time for 21 evaluable patients was 4.1 months.Patients receiving 12.0 mg/kg HS-20093 treatment (n=10) had an ORR of 20.0%.. Two confirmed partial responses were observed in patients in the 12.0mg/kg group, and the responses were maintained until the last follow-up, with the longest response duration being 4.0 months. Received8 mg/kgPatients in the HS-20093 treatment groupThe disease control rate was 81.8% (9/11), receiving12.0 mg/kgPatients in the HS-20093 treatment groupThe disease control rate is100%（10/10）。As of the data cutoff date,The median progression-free survival for all 21 patients has not yet matured.

In terms of safety, 33 patients experienced treatment-emergent adverse events (TEAEs). The common grade 3/4 TEAEs were: neutropenia, leukopenia, thrombocytopenia, lymphopenia, and anemia. The incidence rates of discontinuation, interruption, and dose reduction were 2.9%, 11.8%, and 23.5%, respectively. No deaths due to TEAEs occurred.

The study suggests that these data indicate HS-20093 demonstrates promising antitumor activity and acceptable toxicity in patients with relapsed/refractory osteosarcoma who have undergone extensive prior treatment. Currently, the ARTEMIS-002 study is still ongoing.

References:

[1]ARTEMIS-002: Phase 2 study of HS-20093 in patients with relapsed or refractory osteosarcoma.Retrieved May 24，2024, From https://meetings.asco.org/abstracts-presentations/233377
[2] Hansoh Pharma Insider Information - License Agreement with GSK. Retrieved 2023-12-20, from http://www.cninfo.com.cn/new/disclosure/detail?

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