Greenwich LifeSciences Announces Preliminary Analysis Showing 80% Recurrence Rate Reduction in the Open Label Arm of FLAMINGO-01

Core Insights - Greenwich LifeSciences, Inc. announced an approximately 80% reduction in breast cancer recurrence rates in the non-HLA-A02 arm of its Phase III clinical trial, FLAMINGO-01 [1][4][7] Group 1: Clinical Trial Results - The open label non-HLA-A02 arm of FLAMINGO-01 showed an 80% reduction in recurrence rates compared to historical data from the Katherine study, which reported recurrence rates of about 3.5-4% per year [4][5] - The trial included 250 non-HLA-A02 patients, significantly larger than the approximately 50 patients in the Phase IIb trial, allowing for more robust data [4] - The immune response and safety profile in non-HLA-A02 patients are trending similarly to those in the HLA-A02 arms of FLAMINGO-01 and the Phase IIb study [2][7] Group 2: Immunization Series - The Primary Immunization Series (PIS) consists of 6 GLSI-100 injections over the first 6 months, followed by 5 booster injections every 6 months to enhance long-term immune response [3] - The data suggests that peak immunity is achieved after the completion of the PIS, leading to an 80% reduction in recurrence rates compared to the initial 6 months of vaccination [5] Group 3: Future Directions - The company plans to continue treating non-HLA-A02 patients in a placebo-controlled manner within the study, with ongoing data analysis and potential updates [7] - FLAMINGO-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients, with plans to expand to 150 clinical sites globally [9]