Greenwich LifeSciences presents FLAMINGO-01 immune response data

Greenwich LifeSciences Inc. (NASDAQ: GLSI) presented data from its ongoing FLAMINGO-01 Phase III clinical trial at the ASCO Annual Meeting. The company reported preliminary injection site reaction immune response results from the open-label arm of the study evaluating GLSI-100, an immunotherapy designed to prevent breast cancer recurrences.

The trial enrolled 247 non-HLA-A*02 patients who received GLSI-100 treatment. According to the data, patients showed statistically significant increases in injection site reactions over time. Erythema reactions increased from 20.2% of patients after the first vaccination to 55.3% after the fourth, fifth, or sixth vaccination. Induration reactions rose from 14.9% to 34.6% over the same period.

The study measures immune responses through skin tests and injection site reactions 48-72 hours after injection. The company stated that 208 patients had both baseline vaccination and later vaccination assessments for comparison.

FLAMINGO-01 is evaluating GLSI-100 in HER2-positive breast cancer patients who had residual disease or high-risk pathologic complete response after surgery and completed neoadjuvant and adjuvant trastuzumab-based treatment. The trial includes approximately 140 sites in the US and Europe.

The treatment protocol involves six intradermal injections over the first six months, followed by five booster injections over 2.5 years. The company previously reported that a preliminary analysis showed an approximately 70-80% reduction in recurrence rates after the primary immunization series in the non-HLA-A*02 arm.

The study continues with ongoing data collection. Greenwich LifeSciences stated that final results may vary as the trial progresses and data cleaning is completed.

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