The European Medicines Agency (EMA) has approved the expansion of Greenwich LifeSciences’ Phase III FLAMINGO-01 breast cancer trial in Europe to add 11 new sites across Germany, Poland, and Spain.
This trial evaluates the immunotherapy GLSI-100 for preventing breast cancer recurrences.
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The approved expansion will allow the activation of nearly 110-115 sites throughout Europe.
Further applications to include 5-10 additional sites in Romania, Ireland, and other European nations, are being planned by the company to submit to the EMA regulators depending on the principal investigators’ interest.
Greenwich LifeSciences CEO Snehal Patel said: “The expansion of FLAMINGO-01 into Europe has been complimentary to the activated sites in the US, which also increased in 2024.
“In total we now have approximately 100 sites globally that are activated and screening patients. We believe that the interest level in Europe is very high as we have seen a large increase in patient screening in the second half of 2024.”
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By GlobalDataLed by Baylor College of Medicine, FLAMINGO-01 is a pivotal trial assessing the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
The trial includes US university-based hospitals and cooperative networks, with plans to open up to 150 sites globally.
Around 500 HLA-A*02 subjects will be randomised to receive either GLSI-100 or a placebo in the double-blinded arms of the Phase III trial.
Additionally, up to 250 subjects with other human leukocyte antigens (HLA) types will be treated with GLSI-100 in a separate arm.
The trial aims to identify a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events to occur.
An interim analysis for superiority and futility is planned when at least 14 events have been recorded.
The trial’s design ensures an 80% power to detect a significant difference if the annual rate of events in placebo-treated subjects is 2.4% or higher.
In August 2022, the company commenced the Phase III Flamingo-01 trial of GLSI-100.
