Greenwich LifeSciences Announces Poster Presentation of Five Year Data for GP2 Phase IIb Clinical Trial, Showing 0% Recurrence of Breast Cancer
Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced the publication of a poster for the GP2 Phase IIb clinical trial final efficacy analysis at the San Antonio Breast Cancer Symposium in a virtual format. The CEO of Greenwich LifeSciences, Snehal Patel, also recorded an audio track providing an overview. The full poster with figures, tables, and audio can be accessed or downloaded here on the Company website, as well as on the conference website by attendees.
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Poster PS10-23: San Antonio Breast Cancer Symposium 2020 Poster Presentation of GP2 Median 5 Year Top-Line Data (Graphic: Business Wire)
The poster presents the final 5 year follow-up disease-free survival curves evaluating the reduction of breast cancer recurrences for both HER2/neu 3+ (Figure 1) and HER2/neu 1-2+ (Figure 2) patient populations, including the demographics (Table 1) for stage of cancer, hormone receptor status, node status, and prior treatment with chemotherapy, radiation, endocrine therapy, or trastuzumab (Herceptin).
Mr. Patel commented, “The poster presented at the SABCS is important because the Kaplan Meier survival curves and demographic data further validate our promising HER2 3+ Phase IIb data and support our plan to commence a Phase III trial in 2021. Recurring breast cancer affects 1 in 8 women. Approximately 50% of women with recurring breast cancer do not respond to Herceptin or Kadcyla, resulting in metastatic breast cancer and a poor prognosis. Approximately 80-85% of metastatic breast cancer patients do not survive. By addressing this unmet need, GP2 may reach a potential market exceeding $5 billion.”
The conclusions of the poster are as follows:
‒ The trial met all of its clinical endpoints for HER2/neu 3+ patients, concluding that the first 6 intradermal injections of GP2+GM-CSF safely elicited a potent immune response and reduced recurrence rates to 0% in HER2/neu 3+ patients, who received a standard course of Herceptin after surgery. This reduction of recurrence rate was maintained over the gold standard of 5 years of follow-up. A pivotal Phase III trial is being initiated to treat HER2/neu 3+ patients in the neoadjuvant setting.