Greenwich LifeSciences is significantly expanding its Phase III FLAMINGO-01 clinical trial, which is evaluating GLSI-100, an immunotherapy designed to prevent breast cancer recurrences. The company has made strategic partnerships and site additions across the United States and Europe, enhancing the trial's scope and expertise.
Expansion into Europe
Greenwich LifeSciences has partnered with Unicancer, the largest academic breast cancer research network in France, to activate approximately 19 clinical sites for the FLAMINGO-01 study. This collaboration aims to leverage Unicancer's extensive network, which includes 18 Cancer Centers (CLCCs) caring for nearly 530,000 patients annually.
According to the European Cancer Information System, France diagnosed 66,328 new cases of breast cancer in 2022, making it the most common cancer in women, accounting for approximately 33% of all cancers in women. Breast cancer was also the leading cause of cancer death in women in France, with 14,739 deaths in 2022.
"Participation in the FLAMINGO study will allow us to stay at the forefront of clinical research in the domain of vaccination against cancer," said Dr. T. Bachelot, President of the UCBG.
In Germany, Greenwich LifeSciences has partnered with GBG (German Breast Group), the largest academic breast cancer research network in the country, with approximately 38 sites participating in FLAMINGO-01. The GBG Forschungs GmbH, is recognized as one of the world's leading breast cancer research organizations. In 2023, GBG published 64 research articles with a cumulative impact factor of 1,291.
Data from the European Cancer Information System indicates that in 2022, Germany had 75,267 new cases of breast cancer, representing approximately 29% of all cancers in women. Breast cancer was the leading cause of cancer death in women in Germany, with 20,601 deaths.
Professor Sibylle Loibl, a member of the FLAMINGO-01 Steering Committee, stated, "This trial has the potential to further improve our understanding of preventing breast cancer recurrences and improving patient outcomes."
The European Medicines Agency (EMA) has approved the addition of 11 sites in Spain, Germany, and Poland. Academic networks participating include Geicam (Spain), Unicancer (France), GBG (Germany), GIM (Italy), and a network of Polish sites. This approval paves the way for activating approximately 110-115 sites in Europe.
In Poland, collaboration with Dr. Piotr Wysocki is leading to the activation of 9 to 11 sites. According to the European Cancer Information System, Poland had 24,599 new cases of breast cancer in 2022, representing approximately 25% of all cancers in women, with 8,723 deaths.
U.S. Site Additions and Steering Committee Expansion
In the United States, Harvard University and Johns Hopkins University have joined the FLAMINGO-01 trial, with principal investigators Dr. Laura Spring and Dr. Cesar Santa-Maria joining the Steering Committee. Dr. Spring is a clinical/translational investigator and breast medical oncologist at the Massachusetts General Hospital Cancer Center (MGH) and Harvard Medical School.
Dr. Santa-Maria is a board-certified medical oncologist at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center and Director of Breast Clinical Trials in the Breast and Gynecological Malignancies Disease Group.
Trial Design and Objectives
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial evaluating the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2-positive breast cancer patients with residual disease or high-risk pathologic complete response after surgery, who have completed neoadjuvant and postoperative adjuvant trastuzumab-based treatment. The trial, led by Baylor College of Medicine, aims to expand to 150 sites globally.
The trial is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events. 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.
