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GSK plc (LSE/NYSE:GSK) announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to GSK5764227 (GSK'227), the Company’s investigational B7-H3-targeted antibody-drug conjugate (ADC). This designation is for the treatment of patients with extensive-stage small-cell lung cancer (ES-SCLC) who have experienced disease progression on or after platinum-based chemotherapy.
The Breakthrough Therapy Designation is intended to expedite the development and review of drugs that show potential to offer substantial improvements over existing therapies for serious conditions. For ES-SCLC, which is a particularly aggressive form of lung cancer, current treatment options are limited and often result in poor outcomes. GSK's designation highlights the promising early clinical evidence observed with GSK'227 in treating this challenging tumor type.
Hesham Abdullah, Senior Vice President and Global Head of Oncology R&D at GSK, emphasized the significance of this designation: “Extensive-stage small-cell lung cancer is aggressive with poor prognosis and significant need for new treatments. Today's Breakthrough Therapy Designation supports our ambition to accelerate GSK'227 for these patients as part of our broader ADC program focused on developing new treatment options with transformational and first-to-market potential.”
Lung cancer remains one of the most prevalent cancers worldwide, with small-cell lung cancer (SCLC) accounting for approximately 15% of all cases in the US. Among these, 70% are classified as extensive-stage, where the cancer has spread beyond the lungs to other parts of the body. This stage of SCLC is notoriously difficult to treat, with a dismal 5-year survival rate of around 3%. Patients who relapse after initial treatment typically have a median overall survival of only 5-6 months with current standard-of-care therapies.
GSK’s GSK'227 is currently under evaluation in the ARTEMIS-001 Phase 1 open-label, multi-center trial, which includes over 200 patients with locally advanced or metastatic solid tumors, including relapsed or refractory ES-SCLC. This trial, previously conducted by Hansoh Pharma, provides the preliminary data supporting the Breakthrough Therapy Designation. Results from this trial are expected to be presented at the 2024 World Conference on Lung Cancer in San Diego, California, from September 7-10.
Earlier this year, GSK acquired exclusive worldwide rights to develop and commercialize GSK'227, excluding certain regions in China, from Hansoh Pharma. The Company plans to initiate global Phase 1/2 trials in the second half of 2024 to further support a registrational pathway for GSK'227, aiming to bring a novel treatment option to patients with this challenging form of cancer.
