1. GLSI reports 80% recurrence rate reduction in FLAMINGO-01 trial. 2. The trial focuses on immunotherapy GLSI-100 for breast cancer prevention. 3. Data is preliminary, following trends similar to Phase IIb results. 4. CEO highlights positive trends despite potential future result variations. 5. FLAMINGO-01 will expand to 150 global clinical sites.
FAQ
Why Bullish?
The reported 80% reduction in recurrence rates is significant, suggesting strong efficacy. Historical comparisons show similar or worse outcomes with existing treatments, indicating GLSI-100 could gain market preference.
How important is it?
The significant announcement about recurrence rate and trial expansion could impact investor confidence and valuation. Success in clinical trials is crucial for future growth and market positioning of GLSI.
Why Long Term?
If GLSI-100 continues to demonstrate efficacy, it could lead to FDA approval and long-term revenue growth. The ongoing clinical trials will solidify its market position over time.
Greenwich LifeSciences Reports Significant Reduction in Breast Cancer Recurrence Rates
STAFFORD, Texas, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI), a leading clinical-stage biopharmaceutical company, announced a remarkable preliminary analysis indicating an approximately 80% reduction in breast cancer recurrence rates within the open label non-HLA-A*02 arm of its Phase III clinical trial, FLAMINGO-01. The trial, which evaluates GLSI-100, an innovative immunotherapy designed to prevent breast cancer recurrences, includes a total of 250 fully enrolled participants in this particular arm.
Key Findings from the FLAMINGO-01 Trial
The analysis utilized two methods to estimate the recurrence rate reduction, revealing findings consistent with previous Phase IIb trial outcomes, where patients with the HLA-A*02 type experienced similar reductions. Notably, while comparative data from other approved products indicated a 20-50% reduction in recurrence rates, GLSI-100 demonstrated a much more substantial decline.
- Trial Enrollment: 250 patients in the non-HLA-A*02 arm.
- Recurrence Rate Reduction: Approximately 80% after completing the Primary Immunization Series (PIS).
- Comparison Group: Patients treated with TDM1 (Kadcyla) showing 3.5-4% recurrences per year in initial years.
Understanding the Primary Immunization Series (PIS)
The PIS for GLSI-100 involves six injections over the first six months, followed by five booster injections every six months. This regimen is critical for achieving peak immune response and long-term protection against breast cancer recurrence. The majority of the 250 treated patients received GLSI-100 after initially being treated with TDM1, which further strengthens the analysis results.
Between the two methods employed to analyze the recurrence rate, the following insights were gleaned:
- Method 1: Compared post-PIS recurrence rates to historical data from the Katherine study.
- Method 2: Analyzed differences in rates during initial six months of vaccination versus post-PIS completion.
Company Insights and Future Directions
CEO Snehal Patel expressed enthusiasm regarding the preliminary findings, stating, "We are very excited to announce in our 100th press release since going public that the first patient has completed the full primary and booster vaccination series in FLAMINGO-01. Despite these being preliminary results, the expectation of an 80% reduction in recurrence rates is enormously encouraging."
The findings from the FLAMINGO-01 trial highlight the potential of GLSI-100 as a crucial development in the fight against breast cancer, specifically for patients categorized as non-HLA-A*02. This could lead to the ongoing treatment of these patients under a controlled placebo setting.
Background on FLAMINGO-01 and GLSI-100
FLAMINGO-01, identified by the ClinicalTrials.gov identifier NCT05232916, is a Phase III clinical trial assessing the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients. These individuals have either residual disease or high-risk pathologic complete response post-surgery, following a regimen of neoadjuvant and postoperative adjuvant trastuzumab treatment. The trial will ultimately involve around 500 HLA-A*02 patients randomized to either GLSI-100 or a placebo, alongside up to 250 patients from other HLA types treated with GLSI-100.
For a deeper dive into GLSI-100 and the FLAMINGO-01 trial, further information can be found on the Company’s official channels.