Hansoh Pharmaceutical's B7-H3-Targeted ADC HS-20093 Receives FDA Breakthrough Therapy Designation for Extensive-Stage Small Cell Lung Cancer

HONG KONG, CHINA - Media OutReach - Hansoh Pharma (03692) announced that GSK's GSK5764227 (also known as HS-20093) has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). This B7-H3-targeted antibody-drug conjugate (ADC) is being evaluated for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed during or after platinum-based chemotherapy (recurrent or refractory).

HS-20093 is a novel B7-H3-targeted ADC, composed of a fully humanized B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor (TOPOi) payload. It is currently undergoing multiple Phase I and Phase II clinical trials in China for the treatment of lung cancer, sarcoma, head and neck cancer, and other solid tumors.

The FDA Breakthrough Therapy Designation was supported by data from the ongoing ARTEMIS-001 Phase I open-label, multi-center trial led by the group. The trial, which involved more than 200 patients, evaluated the safety, tolerability, and preliminary anti-tumor activity of the treatment for locally advanced or metastatic solid tumors, including relapsed or refractory ES-SCLC. The results of the trial will be presented at the 2024 World Conference on Lung Cancer (WCLC) to be held in San Diego, California, USA, from September 7 to 10, 2024.