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

Core Insights - Greenwich LifeSciences, Inc. is conducting a Phase III clinical trial, FLAMINGO-01, to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][13] - Preliminary analysis of open label HLA data indicates that approximately 46% of screened patients possess at least one HLA-A02 allele [2][11] - The trial includes a third open label arm for patients without the HLA-A02 allele, which has been expanded from 100 to 250 patients [7] Trial Design and Patient Population - FLAMINGO-01 is a prospective, randomized, double-blinded, multi-center study with approximately 500 patients with the HLA-A02 allele randomized to receive GLSI-100 or placebo [5][6] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [13] - The patient population is stratified to balance treated and placebo arms, with a focus on major screening criteria [5] HLA Data Analysis - The open label arm investigates the safety and efficacy of GLSI-100 in patients lacking the HLA-A02 allele, with potential for immune response conclusions [3][10] - CEO Snehal Patel noted that the 46% prevalence of HLA-A02 aligns with expectations and supports sample size estimates [4] - The prevalence of double HLA-A02 alleles is about 8%, with various other HLA types also prevalent among the screened patients [11] Ethnic and Racial Prevalence - Among self-reported White patients, approximately 50% have at least one HLA-A02 allele, with 10% having double alleles [11] - In Hispanic or Latino populations, 50% have at least one HLA-A02 allele, with 7% having double alleles [11] - For Black or African-American patients, about 40% have at least one HLA-A*02 allele, while Asian patients show a prevalence of 17% [11] Future Directions - The company is interested in analyzing immune response and efficacy across various HLA types, which may inform commercial development strategies [4][10] - A central laboratory is sequencing DNA to determine HLA types, potentially identifying other alleles that may associate with therapeutic effects [10]