Greenwich LifeSciences, Inc. (GLSI) has shared promising new data from its Phase 3 FLAMINGO-01 trial, showing that breast cancer recurrence rates in one arm of the study has dropped to less than 1% per year- a major step forward for its immunotherapy candidate, GLSI-100.
The update focuses on the open-label arm of the trial, which includes 250 patients who are not HLA-A*02 positive- a genetic marker that typically guides immunotherapy eligibility. All patients in this arm received GLSI-100 after completing standard treatment with Kadcyla (TDM1), and most have now finished the Primary Immunization Series (PIS)- six monthly doses designed to build peak immune protection.
Over an average of 1.2 years of follow-up, the recurrence rate in these patients was just 0.7% per year, compared to the 4% annual rate seen in similar patients treated with Kadcyla alone in the historical Katherine study. That's an 83% reduction, and the difference is statistically significant.
While this arm doesn't include a placebo group, the company used historical comparisons to assess impact. The results mirror earlier findings from GLSI-100's Phase 2b trial, where recurrence rates dropped by up to 80% in HER2-positive patients.
Greenwich emphasized that the data is still preliminary and will be updated as more patient years accumulate. The trial remains blinded in its randomized arms, and future updates may be presented at upcoming conferences.
GLSI-100 combines a HER2-derived peptide (GP2) with GM-CSF to stimulate the immune system and prevent recurrence in high-risk breast cancer patients. The broader FLAMINGO-01 trial is expected to enroll up to 750 patients across three arms, with an interim analysis planned once half of the required recurrence events have occurred.
GLSI has traded between $7.78 and $34.10 over the past year. The stock closed Monday's trading session at $28.13, up 5.20%. In pre-market trading the stock is up $33.58, up 20%.
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