Greenwich LifeSciences, Inc. (NASDAQ: GLSI) provided an update on its Phase 3 FLAMINGO-01 trial evaluating GLSI-100, an immunotherapy designed to prevent breast cancer recurrence. The company announced that the study’s Data Safety Monitoring Board (DSMB) recommended the trial continue without modification following its May 2026 review. This recommendation underscores the safety profile of the investigational therapy and allows the trial to proceed as planned.
The company also disclosed that regulatory authorities in the United States and Europe have supported planned protocol changes. These modifications include expanding enrollment to as many as 2,000 patients, increasing enrollment rates by including all HLA types, and maintaining enrollment through interim analyses. The changes aim to strengthen the study design and increase the probability of success. By broadening the patient population, the trial could yield more generalizable results and potentially accelerate the path to regulatory approval.
Greenwich LifeSciences reported that more than 1,500 patients have been screened across approximately 170 to 180 clinical sites in 11 countries. The company plans to expand into additional European markets as well as the United Kingdom and Canada. This global reach enhances the diversity of the study population and supports the scalability of the treatment if approved.
In addition to the enrollment updates, the company shared preliminary data from the fully enrolled open-label non-HLA-A*02 arm. This data continues to show a 70% to 80% reduction in breast cancer recurrence following the primary immunization series. However, the company emphasized that these findings remain preliminary and are not predictive of the final Phase 3 results. Investors should interpret these early signals with caution, as larger randomized data are needed to confirm efficacy.
The FLAMINGO-01 trial is evaluating GP2, a 9-amino acid transmembrane peptide of the HER2 protein. HER2 is expressed in a variety of common cancers, including 75% of breast cancers at low (1+), intermediate (2+), and high (3+) levels. Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2 to prevent breast cancer recurrences in patients who have previously undergone surgery.
For more information about the trial and company, visit the full press release at https://ibn.fm/elLnN or the company’s website at www.greenwichlifesciences.com.
