Greenwich LifeSciences, Inc. (NASDAQ: GLSI) provided an update on its Phase 3 FLAMINGO-01 clinical trial evaluating GLSI-100, an immunotherapy designed to prevent breast cancer recurrence. The company announced that the Data Safety Monitoring Board (DSMB) recommended the trial continue without modification following its review in May 2026. This recommendation signals that the study is progressing safely and as planned.
In addition, regulatory authorities in the United States and Europe have supported planned protocol changes. These changes 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 goal is to strengthen the study design and increase the probability of success. More than 1,500 patients have already been screened across approximately 170 to 180 clinical sites in 11 countries, with plans to expand into additional European markets, the U.K., and Canada.
Greenwich LifeSciences also reported preliminary data from the fully enrolled open-label non-HLA-A*02 arm. The 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. The immunotherapy, GP2, is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor expressed in 75% of breast cancers at various levels.
The FLAMINGO-01 trial is a pivotal study that, if successful, could offer a new treatment option for breast cancer patients at high risk of recurrence. The expanded enrollment and DSMB approval are critical milestones that bring the therapy closer to potential regulatory submission. For more details, the full press release is available at https://ibn.fm/elLnNA. More information about the company can be found at www.greenwichlifesciences.com.
