Core Insights - Greenwich LifeSciences, Inc. announced an approximately 80% reduction in breast cancer recurrence rates in the non-HLA-A*02 arm of its Phase III clinical trial, FLAMINGO-01 [1][4][7] Group 1: Clinical Trial Results - The open label non-HLA-A*02 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-A*02 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-A*02 patients are trending similarly to those in the HLA-A*02 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-A*02 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]

Core Insights - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial FLAMINGO-01 to Austria, which is aimed at evaluating GLSI-100, an immunotherapy for preventing breast cancer recurrences [1][2] Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy targeting breast cancer recurrences in patients post-surgery [6] - The company has initiated the FLAMINGO-01 trial, which is designed to assess the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients [4][6] Clinical Trial Details - FLAMINGO-01 is a Phase III trial that includes sites in the US and Europe, with plans to expand to 150 sites globally [4] - The trial will randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types [4] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [4] Market Context - In Austria, breast cancer is the most common cancer among women, accounting for about 28% of all female cancers, with 6,070 new cases diagnosed in 2022 [3] - Breast cancer was the leading cause of cancer-related deaths in women in Austria, with 1,789 deaths reported in 2022 [3] Collaboration and Expansion - The company is collaborating with principal investigators at Ordensklinikum Linz in Upper Austria, with plans to activate this site within the year and explore additional sites in Vienna and Salzburg [4]