Shanghai-September 9, 2024, Hansoh Pharmaceutical Group Company Limited is pleased to announce updates from the ongoing Phase I ARTEMIS-001 trial evaluating the safety and efficacy of the B7-H3-targeted antibody-drug conjugate HS-20093 (also known as GSK5764227 or GSK’227) in patients with extensive-stage small-cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy (relapsed or refractory). The dose escalation and expansion trial showed a 61.3% (n=31) and 50.0% (n=22) overall response rate (ORR) and median PFS 5.9months (n=31）and 7.3 months (n=22) in patients receiving 8.0 mg/kg and 10.0 mg/kg of HS-20093 respectively as of data cutoff of June 30, 2024. These data are presented today at the World Conference on Lung Cancer (WCLC) 2024 (7-10 September) in San Diego, California, USA, as an oral presentation.
Eliza Sun, Executive Director of Board, Hansoh Pharmaceutical Group, said: “We are excited about the encouraging results presented at the World Conference on Lung Cancer evaluating HS-20093 in this very difficult to treat patient population. These results, along with our other ongoing trials evaluating HS-20093, continue to further our confidence in bringing this investigational agent forward as a potentially transformative treatment option for patients with unmet needs.”
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “Patients with ES-SCLC face a poor prognosis, with limited treatment options and a significant need for new therapies. These data, which supported GSK’s recent Breakthrough Therapy Designation from the US Food and Drug Administration, represent promising early clinical evidence of the potential for GSK’227 in relapsed or refractory ES-SCLC and support our plans to proceed into phase I/II clinical trials this year.”
The safety and tolerability profile of HS-20093 in patients with ES-SCLC mainly included hematologic and gastrointestinal events. Grade ≥3 treatment-related adverse events (with incidence ≥10%) were neutrophil count decreased (39.3%), white blood cell count decreased (33.9%), lymphocyte count decreased (25.0%), platelet count decreased (17.9%), and anemia (16.1%).
About ES-SCLC
Lung cancer is one of the most common cancers worldwide. ES-SCLC is an aggressive and difficult-to-treat cancer with limited treatment options. More than two thirds of the patients with SCLC are diagnosed with ES-SCLC and the 5-year survival rate is approximately 3%.
ABOUT HS-20093
HS-20093 is a novel B7-H3-targeted antibody-drug conjugate (ADC) composed of a fully-humanized anti-B7-H3 monoclonal antibody covalently linked to topoisomerase inhibitor (TOPOi) payload and being developed for the treatment of lung cancer, sarcoma, head and neck cancers and other solid tumors in multiple phase I and II clinical studies in China.
On December 20, 2023, the Group entered into the License Agreement with GSK, pursuant to which GSK obtained an exclusive worldwide license (excluding the Chinese Mainland, Hong Kong, Macau, and Taiwan) to develop, manufacture and commercialize HS-20093 (also known as GSK’227). GSK’s global Phase I trials for GSK’227 are set to begin this year.
ABOUT ARTEMIS-001
ARTEMIS-001 （NCT05276609） is an open-label, multi-center, dose-escalation and expansion, phase I study in adult participants with locally advanced or metastatic solid tumors, consisting of a dose escalation stage (Phase Ia) and a dose expansion stage (Part Ib).
