Clinical TrialJun 1, 2026, 08:17 AM
Greenwich LifeSciences GLSI-100 Phase III Data Shows Strong Immune Response
AI Summary
Greenwich LifeSciences presented preliminary Phase III FLAMINGO-01 clinical trial data at ASCO 2026, demonstrating statistically significant increases in injection site reactions (ISRs) in non-HLA-A*02 patients treated with GLSI-100. Erythema ISRs rose from 20.2% to 55.3%, and induration ISRs from 14.9% to 34.6% after multiple vaccinations. These findings support the drug's mechanism of action and suggest GLSI-100's applicability beyond HLA-A*02 patients, potentially doubling its market. Preliminary analysis also indicates a 70-80% reduction in recurrence rates in the non-HLA-A*02 arm, consistent with Phase IIb results.
Key Highlights
- Preliminary Phase III FLAMINGO-01 data presented at ASCO 2026.
- Erythema ISRs increased from 20.2% to 55.3% (2.7x increase) after 4th-6th vaccinations (McNemar p < 0.001).
- Induration ISRs increased from 14.9% to 34.6% (2.3x increase) after 4th-6th vaccinations (McNemar p < 0.001).
- Immune reactivity increased by 60% to 280% across HLA-A types with increased GLSI-100 vaccinations.
- Preliminary analysis in non-HLA-A*02 arm shows 70-80% reduction in recurrence rate.
- Non-HLA-A*02 open label arm fully enrolled with 247 patients.
- Phase III trial designed to detect 0.3 hazard ratio, requiring 28 events for interim analysis.
Price Impact
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