Greenwich LifeSciences provides update on Phase III clinical trial Flamingo-01

Greenwich LifeSciences provided the following update on the Phase III clinical trial, Flamingo-01. The Flamingo-01 DSMB met twice in 2023 and recommended to continue the study as is without modification. No serious adverse events related to GLSI-100 have been reported to date. Approximately 30 clinical sites with 87 locations at multiple hospitals and the largest oncology network in the US are currently recruiting patients. Pending European regulatory approval, which is expected in 2024, contracts are in place to add up to an additional 105-120 sites in Europe. European academic networks in each country are planning to participate in Flamingo-01. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in the third arm. For the HLA-A*02 randomized arms, the trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. CEO Snehal Patel commented, “With the addition of the European sites and approximately 150 total sites, peak enrollment rates could be reached by the end of 2024 allowing for a refinement in the interim analysis. Currently, enrollment will likely end before the interim analysis is triggered by 14 events. However, the interim analysis could be modified such that an additional sizing interim analysis is conducted before enrollment ends to reaffirm the size of the 2 randomized arms. While the hazard ratio of 0.3 assumes that the recurrence rate of the treated arm will be 30% of the recurrence rate in the placebo arm and thus a 70% reduction in recurrence rate, and while the Phase II trial showed even greater reduction in recurrence rate, we are likely to see recurrences in the treated arm of the Phase III trial and have designed the trial accordingly. Using the early Phase III trial data to reaffirm the size of the arms of the Phase III trial may be the best information we could use to reduce risk and improve the chances of success of Flamingo-01.”