Greenwich LifeSciences (NASDAQ: GLSI) has announced the completion of enrollment in the open label non-HLA-A*02 arm of FLAMINGO-01.
FLAMINGO-01 is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment.
In a statement, Snehal Patel, CEO of Greenwich, commented, “As we continue to analyze the immune response, safety, and recurrence rate data of the 250 patient non-HLA-A02 data set, it is important to remember that all 250 patients received GLSI-100, which is five times more than the approximately 50 patients treated in the Phase IIb trial. We can compare the open label recurrence rate data of these 250 treated patients to the expected historical recurrence rate for this population, which is well known and recently reported, to the HLA-A02 arms of FLAMINGO-01, and to the Phase IIb study. In addition, we may be able to compare the recurrence rate during the first six months of vaccination, also called the primary immunization series or PIS, to the recurrence rate after the PIS is completed and after peak immunity is achieved. We look forward to providing updates on this analysis at any time, including publications at conferences as we have previously done for the Phase IIb trial from 2020-2022.”
Mr. Patel added, “The use of GLSI-100 in the non-HLA-A*02 patient population is an invention by the company, and the company believes that any patent claims related to this invention are not subject to any license, royalties, or milestone payments. These patent claims should complement other patent claims that the company has recently filed to extend patent protection of GLSI-100 beyond 2040 potentially. The company believes that this patient population could double the number of U.S. and European patients eligible for GLSI-100 treatment to approximately 88,000 new patients per year with a market potential using the drug prices per year of Kadcyla or Enhertu in the range of $8-10 billion per year.”
