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. Regulatory authorities in the U.S. 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 to strengthen the study design and increase the probability of success.
Greenwich LifeSciences reported that 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 disclosed 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, the company 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 various levels. Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on preventing breast cancer recurrences in patients who have undergone surgery. The company's progress in this trial represents a significant step toward potentially offering a new treatment option for breast cancer patients. For more information, visit the company's website at www.greenwichlifesciences.com.
This announcement is important as it highlights the advancement of a novel immunotherapy that could significantly reduce breast cancer recurrence rates. The expanded study design and international enrollment underscore the potential global impact of this treatment. The full press release can be accessed at https://ibn.fm/elLnNA.
