Greenwich LifeSciences Reveals 5-Year Data for GP2 Immunotherapy In Breast Cancer Settings

Greenwich LifeSciences Inc GLSI has published new GP2 Phase 2b trial data. The trial enrolled HER2 positive patients, who received a standard course of trastuzumab after surgery, and HER2 low patients, who did not receive trastuzumab after surgery.

• 22.8% or 33 of the 145 patients reacted to GP2 at baseline with a positive immune response.
• Of the 33 patients who did have a positive baseline DTH immune response to GP2, eight patients recurred, a recurrence rate of 24.2%, with a median time to recurrence of 99 days (0.27 years).
• Of the 112 patients who did not have a positive DTH baseline immune response to GP2, 14 patients recurred a recurrence rate of 12.5%, with a median time to recurrence of 438 days (1.2 years).
• If the patient completed the Primary Immunization Serie, the 5-year disease-free survival rate in the 46 HER2 3+ patients treated with GLSI-100 was 100% versus 89.4% in the 50 placebo patients treated with GM-CSF.
• GLSI-100 was found to be well tolerated with no SAEs deemed related to study medication and elicited a potent immune response.
• Injection site reactions were common, occurring in almost 100% of patients treated with either GLSI-100 or GM-CSF alone.
• Price Action: GLSI shares are down 8.52% at $31.69 during the market session on the last check Thursday.