Greenwich LifeSciences Provides Update on Open Label HLA Data from FLAMINGO-01

Core Viewpoint - Greenwich LifeSciences, Inc. is advancing its Phase III clinical trial, FLAMINGO-01, to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with recent updates on HLA data indicating a 46% prevalence of the HLA-A02 allele among screened patients [1][12]. Group 1: Trial Design and Patient Population - FLAMINGO-01 is a prospective, randomized, double-blinded, multi-center study designed to assess the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients [5][12]. - Approximately 500 patients with the HLA-A02 allele will be randomized to receive GLSI-100 or a placebo, while an additional 250 patients without the HLA-A02 allele will be enrolled in an open label arm [6][13]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [13]. Group 2: HLA Data Insights - Preliminary analysis shows that about 46% of all screened patients possess at least one HLA-A02 allele, aligning with the expected prevalence of 40-50% [2][4]. - The prevalence of double HLA-A02 alleles, where patients receive the allele from both parents, is approximately 8% [12]. - The trial will also explore various HLA-A types and their combinations to assess immune response and clinical outcomes, potentially informing commercial development strategies [4][11]. Group 3: Ethnic and Racial Prevalence - Among self-reported White patients, approximately 50% have at least one HLA-A02 allele, with 10% having double HLA-A02 alleles [12]. - In Hispanic or Latino patients, the prevalence of at least one HLA-A02 allele is also around 50%, with 7% having double alleles [12]. - For Black or African-American patients, about 40% have at least one HLA-A*02 allele, while the prevalence in Asian patients is approximately 17% [12].