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. Additionally, regulatory authorities in the United States and Europe have supported planned protocol changes that include expanding enrollment to as many as 2,000 patients, increasing enrollment rates by including all HLA types, and maintaining enrollment through interim analyses. These changes aim to strengthen the study design and increase the probability of success.
According to the company, more than 1,500 patients have been screened across approximately 170 to 180 clinical sites in 11 countries, with plans to expand into additional European markets as well as the U.K. and Canada. The company also reported preliminary data from the fully enrolled open-label non-HLA-A*02 arm, which continues to show a 70% to 80% reduction in breast cancer recurrence following the primary immunization series. However, Greenwich LifeSciences emphasized that these findings remain preliminary and are not predictive of the final Phase 3 results.
The FLAMINGO-01 trial is evaluating GP2, a 9 amino acid transmembrane peptide of the HER2 protein, which is expressed in 75% of breast cancers at low, intermediate, and high levels. Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2 as an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. For more information, visit the company's website at www.greenwichlifesciences.com.
The full press release is available at https://ibn.fm/elLnN. This announcement underscores the potential of GLSI-100 to address a significant unmet medical need in breast cancer recurrence prevention.
