Greenwich LifeSciences has announced a collaboration with Gruppo Italiano Mammella (GIM), Italy's largest academic cooperative breast cancer research group, to include Italian sites in its Phase III FLAMINGO-01 trial. The trial is evaluating GLSI-100, an immunotherapy designed to prevent breast cancer recurrence. This partnership aims to address the significant unmet medical need in Italy, where 58,160 new breast cancer cases were diagnosed in 2022, representing approximately 30% of all cancers in women.
Italian Expansion of FLAMINGO-01
Nine leading institutions within the GIM network, comprising over 150 participating centers and approximately 500 investigators, will participate in the FLAMINGO-01 trial. These sites have received approval from Italian authorities, facilitating in-person training and initiation activities. Updates on the FLAMINGO trial and potential new research proposals were discussed at the annual national GIM conference in September 2024.
Professor Grazia Arpino, Professor in Oncology and head of the Breast Cancer Group at the University of Naples Federico II, emphasized the importance of the trial, stating, "The FLAMINGO-01 trial is of great interest to me and to my patients... I felt that it was important to give the opportunity to patients in Italy to participate in the trial... My institution was the first site in Italy to be activated, and we have already started enrollment and treatment of patients."
GLSI-100 and the FLAMINGO-01 Trial Design
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial assessing the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2-positive breast cancer patients. These patients must have residual disease or high-risk pathologic complete response post-surgery and have completed neoadjuvant and postoperative adjuvant trastuzumab-based treatment. The trial, led by Baylor College of Medicine, initially included US clinical sites and is now expanding into Europe, aiming for 150 sites globally.
The trial design includes a double-blinded arm where approximately 500 HLA-A*02 patients will be randomized to either GLSI-100 or placebo. Additionally, up to 250 patients with other HLA types will be treated with GLSI-100 in a separate arm. The study is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for the primary analysis. An interim analysis for superiority and futility is planned after at least half of these events (14) have occurred. This sample size provides 80% power, assuming an annual event rate of 2.4% or greater in placebo-treated subjects.
Addressing HER2-Positive Breast Cancer
Professor Sabino De Placido, head of the GIM group, noted the advancements in HER2-positive breast cancer treatment but highlighted the remaining need for improvement, especially in high-risk patients. "The vaccine being tested in the FLAMINGO-01 study offers an excellent, innovative opportunity to reduce these relapses without increasing the side effects of treatment," he stated.
Management Perspective
CEO Snehal Patel commented on the expansion, "Italy is the first country where we have personally visited and trained all of the sites participating in FLAMINGO-01... We are truly grateful for the time and commitment from our Italian colleagues."
