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 endorsement signals that the interim safety data do not raise concerns, allowing the trial to proceed as planned.
Regulatory authorities in the United States and Europe have supported planned protocol changes that include expanding enrollment to as many as 2,000 patients. The amendments also include increasing enrollment rates by including all HLA types and maintaining enrollment through interim analyses. These changes are intended to strengthen the study design and increase the probability of success. The expanded criteria could accelerate patient recruitment and enhance the statistical power of the trial.
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 broad geographic reach may facilitate faster enrollment and provide a more diverse patient population for the study.
Preliminary data from the fully enrolled open-label non-HLA-A*02 arm 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 data suggest potential efficacy, but definitive conclusions await the trial’s completion.
The FLAMINGO-01 trial evaluates GLSI-100, which targets GP2, a peptide derived from the HER2 protein. HER2 is expressed in a variety of common cancers, including 75% of breast cancers at low, intermediate, and high levels. Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2 immunotherapy to prevent breast cancer recurrences in patients who have 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.
