Greenwich LifeSciences Provides Global Update on FLAMINGO-01, Screening Over 1,000 Patients to Date

Core Viewpoint - Greenwich LifeSciences, Inc. is making significant progress in its Phase III clinical trial, FLAMINGO-01, aimed at evaluating GLSI-100, an immunotherapy for preventing breast cancer recurrences [1][2]. Group 1: FLAMINGO-01 Progress - The company has screened over 1,000 patients in the FLAMINGO-01 trial, maintaining a screening rate of approximately 150 patients per quarter, equating to 600 patients annually across 140 active sites [2][3]. - The company is considering a strategy to continue enrolling patients in both HLA-A02 and non-HLA-A02 arms until interim analyses are conducted [2]. Group 2: Clinical Trial Details - FLAMINGO-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have residual disease or high-risk pathologic complete response after surgery [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]. - An interim analysis for superiority and futility will be conducted after at least 14 events have occurred, with the trial designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival [4]. Group 3: Company Overview - Greenwich LifeSciences is focused on developing GP2, an immunotherapy aimed at preventing breast cancer recurrences in patients post-surgery [6]. - The company is actively expanding its clinical trial sites, with plans to open up to 150 sites globally [4].