GSK secures FDA breakthrough therapy designation for GSK5764227 in lung cancer treatment

GSK plc (LSE/NYSE: GSK) has announced a significant milestone in its oncology program, with the US Food and Drug Administration (FDA) granting Breakthrough Therapy Designation for its investigational drug GSK5764227 (GSK’227). This designation, aimed at expediting the development and review of drugs that could offer substantial improvements over existing therapies, underscores the potential of GSK’227 in treating patients with extensive-stage small-cell lung cancer (ES-SCLC) who have experienced disease progression following platinum-based chemotherapy.

Potential Game-Changer in Lung Cancer Treatment

Lung cancer remains one of the most prevalent cancers globally, with small-cell lung cancer (SCLC) comprising about 15% of all lung cancer cases in the United States. The aggressive nature of extensive-stage SCLC, which affects approximately 70% of SCLC patients, is underscored by a dismal 5-year survival rate of around 3%. The standard of care for relapsed ES-SCLC offers limited efficacy, with median overall survival rates lingering between 5 to 6 months. In this context, GSK’227 represents a promising new option.

Hesham Abdullah, Senior Vice President and Global Head of Oncology R&D at GSK, commented on the breakthrough: “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.”

Strategic Acquisition and Trial Progress

Earlier in 2024, GSK secured exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) to develop and commercialize GSK’227 from Hansoh Pharma. The FDA’s Breakthrough Therapy Designation is supported by encouraging data from the ongoing ARTEMIS-001 Phase 1 trial, an open-label, multi-center study involving over 200 patients. This trial, conducted by Hansoh Pharma, is assessing the safety, tolerability, and preliminary anti-tumor activity of GSK’227 in various advanced solid tumors, including relapsed or refractory ES-SCLC.

The findings from ARTEMIS-001 will be unveiled at the upcoming World Conference on Lung Cancer, scheduled from September 7-10, 2024, in San Diego, California. Building on these results, GSK plans to launch global Phase 1/2 trials in the latter half of 2024, aiming to establish a registrational pathway for GSK’227.

A Novel Approach to Cancer Treatment

GSK5764227, also referred to as HS-20093, is a cutting-edge investigational B7-H3-targeted antibody-drug conjugate (ADC). The ADC consists of a fully humanized anti-B7-H3 monoclonal antibody, which is covalently linked to a topoisomerase inhibitor (TOPOi) payload. This innovative drug is being developed by Hansoh Pharma to target various cancers, including lung cancer, sarcoma, and head and neck cancers, through multiple Phase I and II clinical trials in China. GSK’s global Phase I trials for GSK5764227 are set to commence in the second half of 2024.

The Breakthrough Therapy Designation marks a crucial step forward in GSK’s mission to offer transformative treatments for aggressive and difficult-to-treat cancers like ES-SCLC. With promising preliminary results and strategic global partnerships, GSK’227 could soon provide a much-needed new option for patients battling this devastating disease.