Greenwich LifeSciences Sees 33% Surge in Trial Screening, Non-HLA Arm Shows 80% Recurrence Drop
Greenwich LifeSciences boosted its FLAMINGO-01 trial screening to over 800 patients per year, a 33% rise from 600 annual screens, driven by new and high-performing sites activated in 2025. The non-HLA-A*02 arm’s 250 patients showed a preliminary 80% reduction in recurrence after the primary immunization series.
1. Screening Rate Increase
Greenwich LifeSciences achieved its highest patient screening pace in FLAMINGO-01, reaching approximately 200 patients per quarter (over 800 annually), a 33% jump from the previous 600 per year. This growth reflects the activation of new U.S. and EU clinical sites in 2025 and increased patient momentum at existing centers.
2. Non-HLA-A*02 Arm Enrollment and Preliminary Efficacy
The non-HLA-A*02 arm has now enrolled all 250 planned patients, who have completed the Primary Immunization Series with GLSI-100. Preliminary analysis after the initial six-month series indicates an 80% reduction in breast cancer recurrence, mirroring results from the earlier Phase IIb study.
3. Trial Design and Next Milestones
FLAMINGO-01 is a Phase III trial evaluating Fast Track-designated GLSI-100 in up to 500 HLA-A*02 patients randomized between active treatment and placebo and 250 non-HLA patients in an open-label arm. The study plans an interim superiority and futility analysis at 14 invasive breast cancer events and aims for a hazard ratio of 0.3 in invasive disease-free survival.