Greenwich LifeSciences is making significant strides with its Phase III clinical trial, Flamingo-01, designed to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The company has received approval to expand the trial into Europe's five largest countries and is broadening patient enrollment in the US. These developments promise to accelerate the trial and potentially extend the benefits of GLSI-100 to a wider patient population.
European Expansion Approved
Flamingo-01 has been formally approved for expansion into Spain, France, Germany, Italy, and Poland. This expansion will incorporate academic networks such as Geicam (Spain), Unicancer (France), GBG (Germany), and GIM (Italy). With regulatory clearance secured, Greenwich LifeSciences plans to activate 105 sites across these countries, with site initiation visits commencing as early as the week of March 4, 2024. This strategic move aims to tap into a population of approximately 300 million people, significantly enhancing patient enrollment and study progress.
According to CEO Snehal Patel, "The interest in developing a vaccine to prevent the recurrence of breast cancer is very high in the European clinical and academic community, especially given the promising efficacy and safety profile from the prior GLSI-100 trials."
Expansion of Non-HLA-A*02 Patient Enrollment
The Flamingo-01 Steering Committee has agreed to expand the third arm of the study to enroll up to 250 patients with non-HLA-A02 types. This decision follows new research suggesting that GP2, the active ingredient in GLSI-100, may bind to various HLA types, not just HLA-A02. This expansion could potentially broaden the patient population who could benefit from this immunotherapy.
Dr. Mothaffar F. Rimawi, Chair of the Steering Committee, noted, "The expansion of the unblinded non-HLA-A*02 arm is also significant as it reflects the interest among patients and investigators in exploring the activity of GLSI-100 in these patients, which may expand the patient population who could benefit from this exciting vaccine."
Planned Interim Analysis and BLA Preparation
The Flamingo-01 trial is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for the primary analysis. An interim analysis for superiority and futility is planned after at least half of these events (14) have occurred. The trial's design provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
Greenwich LifeSciences is also actively preparing for the submission of a Biologics License Application (BLA) in the US. This includes compiling commercial manufacturing data and study reports from prior clinical trials. The company has completed the first three commercial lots of GP2 active ingredient, which could be used to prepare approximately 200,000 doses. Additionally, a comprehensive study report of the Phase II trial is being prepared for the FDA.
About Flamingo-01 and GLSI-100
Flamingo-01 (NCT05232916) is a Phase III clinical trial evaluating the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who have completed both neoadjuvant and postoperative adjuvant trastuzumab-based treatment. The trial aims to enroll approximately 500 HLA-A*02 patients in the double-blinded arms and up to 250 patients of other HLA types in the third arm.
