Greenwich LifeSciences Reports Significant Immune Response Data in FLAMINGO-01 Trial — Greenwich LifeSciences, Inc.

Event summary

Greenwich LifeSciences presented preliminary immune response data from the FLAMINGO-01 Phase III trial at AACR Meeting 2026, showing a significant increase in DTH reactions in non-HLA-A*02 patients.
The frequency of DTH reactions increased by approximately 4x (290%) from baseline to month 4 or 6 in the open-label arm.
Over 1,300 patients have been screened for the FLAMINGO-01 trial, with the non-HLA-A*02 arm now fully enrolled.

The big picture

Greenwich LifeSciences' FLAMINGO-01 trial data suggests that its immunotherapy, GLSI-100, could be effective in a broader patient population than initially targeted. This aligns with the growing trend of personalized medicine and the push for immunotherapies that can address unmet needs in cancer treatment. The company's ability to secure regulatory approval for this expanded use will be critical in determining its market potential.

What we're watching

Regulatory Approval Pathway: Whether the FDA's review of protocol changes will allow for combined analysis of HLA-A*02 and non-HLA-A*02 patients, potentially expediting approval.
Clinical Efficacy Validation: The pace at which final results from FLAMINGO-01 will confirm the preliminary 70-80% reduction in recurrence rates observed in non-HLA-A*02 patients.
Market Expansion Strategy: How Greenwich LifeSciences will leverage the immune response data to expand the patient population eligible for GLSI-100 treatment beyond HLA-A*02 genotypes.