Greenwich LifeSciences Expands FLAMINGO-01 Breast Cancer Trial to Ireland, Adding to Global Network of 150 Sites
Key Insights
Greenwich LifeSciences received European regulatory approval to expand its Phase III FLAMINGO-01 clinical trial to Ireland, adding to a global network of 150 trial sites across seven countries.
The trial evaluates GLSI-100 immunotherapy in HER2-positive breast cancer (search) patients with residual disease or high-risk pathologic complete response after surgery and trastuzumab treatment.
Ireland diagnosed 3,723 new breast cancer (search) cases in 2022, representing 30% of all cancers in women and the second leading cause of cancer death with 883 deaths.
Greenwich LifeSciences has received formal approval from European regulators to expand its Phase III FLAMINGO-01 clinical trial to Ireland, marking a significant milestone in the company's global clinical development strategy. The expansion adds Ireland to an international network that now includes Spain, France, Germany, Italy, Poland, Romania, and the United States, with plans to open up to 150 sites globally.
Clinical Trial Design and Patient Population
FLAMINGO-01 (NCT05232916) is evaluating GLSI-100 (GP2 + GM-CSF), an immunotherapy designed to prevent breast cancer (search) recurrences in HER2 (search)-positive patients. The trial targets patients who had residual disease or high-risk pathologic complete response at surgery and have completed both neoadjuvant and postoperative adjuvant trastuzumab-based treatment.
The double-blinded Phase III trial will randomize approximately 500 HLA-A*02 (search) patients to GLSI-100 or placebo, with up to 250 patients of other HLA types receiving GLSI-100 in a third arm. The study has been designed to detect a hazard ratio of 0.3 in invasive breast cancer (search)-free survival, requiring 28 events for analysis. An interim analysis for superiority and futility will be conducted when at least 14 events have occurred, with the sample size providing 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
Ireland's Clinical Research Landscape
The expansion to Ireland addresses a significant medical need in the country, where breast cancer (search) represents a substantial health burden. According to the European Cancer Information System, Ireland diagnosed 3,723 new cases of breast cancer in 2022, making it the most common cancer diagnosed in women and representing approximately 30% of all cancers in women. Breast cancer is the second leading cause of death from cancer in women in Ireland, with 883 deaths recorded in 2022.
Dr. Janice Walshe from St Vincent's University Hospital in Dublin will serve as the national principal investigator for FLAMINGO-01 in Ireland. Dr. Walshe is a key member of Cancer Trials Ireland research group, ensuring access to novel agents and research opportunities for Irish women affected by breast cancer (search). Through the clinical research clinic at St Vincent's University Hospital, she has served as national principal investigator for numerous important international trials in breast cancer and was a three-year member of the ASCO Scientific Program Committee in triple negative breast cancer from 2013-2015.
Strategic Implications and Market Context
The HER2 (search) protein is expressed in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels, representing a significant patient population. In the United States alone, one in eight women will develop invasive breast cancer (search) over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors.
CEO Snehal Patel commented on the expansion: "We have visited St. Vincent's multiple times over the past few years, once to present GP2 and FLAMINGO-01 at their conference and most recently to train the study team. We have also been approached by Irish breast cancer (search) patients who wish to participate in FLAMINGO-01 and who can now be considered for enrollment through the Dublin site."
Regulatory Status and Development Timeline
The FLAMINGO-01 trial is led by Baylor College of Medicine and currently includes clinical sites from university-based hospitals and academic and cooperative networks across the United States and Europe. The trial has received Fast Track Designation from the FDA, signaling regulatory recognition of the potential therapeutic benefit.
GLSI-100 consists of GP2, a 9 amino acid transmembrane peptide of the HER2 (search) protein, combined with GM-CSF as an adjuvant. The immunotherapy approach aims to stimulate the immune system to recognize and eliminate cancer cells expressing the HER2 protein, potentially preventing disease recurrence in high-risk patients who have completed standard treatment protocols.