GSK’227 Gets FDA Breakthrough Therapy Designation for ES-SCLC

A novel treatment for extensive-stage small cell lung cancer has received a breakthrough therapy designation from the FDA.

The Food and Drug Administration (FDA) has granted breakthrough therapy designation to the antibody-drug conjugate GSK5764227 (GSK’227) for the treatment of relapsed or refractory extensive-stage small cell lung cancer.

GSK’227 manufacturer GSK announced in a news release that it plans to begin global phase 1/2 trials in support of a registrational pathway for the drug in the second half of this year.

The breakthrough therapy designation process is “designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s),” the FDA states on its website.

Approximately 10% to 15% of lung cancers are small cell lung cancer, and about two-thirds of people with small cell lung cancer have extensive-stage disease — meaning it has spread throughout the lung, to the other lung or other parts of the body — at diagnosis, according to the American Cancer Society. GSK, in its news release, cited statistics that the five-year survival rate of extensive-stage small cell lung cancer is 3% and that the median overall survival (how long a patient lives, regardless of disease status) for patients with relapsed disease is five to six months.

Antibody-drug conjugates (ADC) such as GSK’227 deliver chemotherapy directly to cancer cells with the intention of sparing healthy cells from harmful effects.

Learn More in Our “Speaking Out” Video Series: Advancements, Challenges and Hope in a ‘Pivotal Year’ for Lung Cancer Research

“Extensive-stage small-cell lung cancer is aggressive with poor prognosis and significant need for new treatments. [This] 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, Global Head Oncology, R&D, GSK, in the company’s news release.

The breakthrough therapy designation for patients who have experienced disease progression on or after platinum-based chemotherapy was supported by data from the phase 1 ARTEMIS-001 clinical trial.

Data from ARTEMIS-001 presented this year at the American Society of Clinical Oncology Annual Meeting showed what researchers described as encouraging efficacy, with 96.2% of patients experiencing tumor shrinkage in targeted lesions, with deep responses experienced by 44.2% of patients.

Further results from the trial will be presented in September at the 2024 World Conference on Lung Cancer, GSK announced.

The breakthrough therapy designation received by GSK’227 is the latest promising news announced this year for patients with extensive-stage small cell lung cancer. In May, the FDA approved Imdelltra for the treatment of patients with advanced small cell lung cancer that progressed on or after a platinum-based chemotherapy.

LEARN MORE: Imdelltra for Small Cell Lung Cancer Addresses Key Unmet Needs

These developments echo what Amy C. Moore, vice president of global engagement and patient partnerships for the LUNGevity Foundation, told CURE® earlier this year about small cell lung cancer: It’s a time to be hopeful.

“There have been various reasons why we haven’t seen as many gains in this space,” Moore said. “I think it’s just a much different beast than non-small cell lung cancer (NSCLC) for a variety of reasons. But we’re more hopeful now than we’ve been in quite some time.”

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