GSK5764227 Receives Breakthrough Therapy Designation to Treat Extensive-Stage Small–Cell Lung Cancer

The FDA has granted breakthrough therapy designation for GSK5764227 (GSK’227; GSK), an investigational B7-H3-targeted antibody drug conjugate (ADC) for the treatment of extensive-stage small–cell lung cancer (ES-SCLC) among individuals with disease progression who are on or following platinum-based chemotherapy.¹

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Around 15% of lung cancer cases in the U.S are small cell, and 70% of cases are in the extensive stage of the disease. According to the American Cancer Society, the extensive stage occurs when the cancer has spread throughout the lung, to the other lung, or to other parts of the body, including the bone marrow and the lymph nodes.² Study authors noted that ES-SCLC is difficult to treat and has limited treatment options, as only 3% of individuals who are diagnosed survive 5 years. Additionally, most individuals with ES-SCLC relapse following first line of treatment with current standard-of-care treatments with the median overall survival of 5 to 6 months, according to study authors.¹

“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,” said Hesham Abdullah, senior vice president and global head of oncology research and development at GSK, in a news release.¹

The study authors noted that GSK’227, also known as HS-20093, is composed of a “fully humanised anti-B7-H3 monoclonal antibody covalently linked to topoisomerase inhibitor (TOPOi) payload.”¹

“B7-H3 is highly expressed in a broad range of solid tumors where there remains a significant need for novel treatment options. We look forward to progressing this potential new treatment across several indications and in future potential combination approaches with our established portfolio,” said Abdullah, in a news release.³

The breakthrough therapy designation was granted based on data from the ARTEMIS-001 Phase 1 open-label, multi-center trial, which is ongoing. The study includes 200 individuals and is assessing the safety, tolerability, and preliminary anti-tumor activity among individuals with locally advanced or metastatic solid tumors as well as relapsed or refractory ES-SCLC.¹

“HS-20093 is a novel B7-H3 targeting antibody-drug conjugate showing encouraging early clinical signals in lung cancer. We are excited to enter this new license agreement with GSK, our existing licensee on HS-20089, furthering Hansoh’s goal of bringing a potentially transformative treatment option to cancer patients globally,” said Eliza Sun, Executive Director of Board, Hansoh Pharma, in a news release.³

REFERENCES

1. GSK receives US FDA Breakthrough Therapy Designation for its B7-H3-targeted antibody-drug conjugate in relapsed or refractory extensive-stage small-cell lung cancer. GSK. News release. August 20, 2024. Accessed August 20, 2024. https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-breakthrough-therapy-designation/.

2. Small Cell Lung Cancer Stages. American Cancer Society. News release. January 29, 2024. Accessed August 20, 2024. https://www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/staging-sclc.html#:~:text=This%20describes%20cancers%20that%20have,be%20extensive%20stage%20as%20well.

3. GSK enters exclusive license agreement with Hansoh for HS-20093. GSK. News release. December 20, 2023. Accessed August 20, 2024. https://www.gsk.com/en-gb/media/press-releases/gsk-enters-exclusive-license-agreement-with-hansoh-for-hs-20093/.