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 that two abstracts have been accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS), including two corresponding posters. SABCS 2020 will be held in a virtual format from December 8-11, 2020. SABCS anticipates publishing the abstracts in late November 2020 and the posters on December 9, 2020.
Snehal Patel, CEO of Greenwich LifeSciences, commented, "While we previously reported that in the GP2 Phase IIb clinical trial that no recurrences were observed in the HER2/neu 3+ adjuvant setting after 5 years of follow-up if the patient received their primary GP2 treatments, we are pleased to be able to present the final 5 year analysis, including Kaplan-Meier disease free survival curves and patient demographics."
Dr. F. Joseph Daugherty, CMO of Greenwich LifeSciences, commented, "We look forward to sharing this data with breast cancer key opinion leaders as we recruit clinicians and clinical sites for participation in our planned Phase III clinical trial. This data will further advance the development of GP2 and support our common goal to provide patients and clinicians with a safe and effective treatment option to prevent recurrences following surgery, and thereby prevent metastatic breast cancer."
The first abstract and poster will present the final 5 year follow-up efficacy and demographic data across all patient populations from the completed prospective, randomized, placebo-controlled, single-blinded, multicenter, Phase IIb clinical study evaluating the reduction of recurrences. The presentation will include disease free survival curves for both HER2/neu 3+ and HER2/neu 1-2+ patient populations, including the demographics for stage of cancer, hormone receptor status, node status, and prior treatment with chemotherapy, radiation, endocrine therapy or trastuzumab.
The second abstract and poster will present the design of the planned Phase III clinical trial. The trial is designed as a single registration trial which will include an interim analysis seeking conditional marketing approval from the FDA upon the interim analysis data read out followed by submission of a Biologics Licensing Application (BLA).
The 2 abstracts and posters are entitled:
Program Number: PS10-23 - Five year median follow-up data from a prospective, randomized, placebo-controlled, single-blinded, multicenter, Phase IIb study evaluating the reduction of recurrences using HER2/neu peptide GP2 + GM-CSF vs. GM-CSF alone after adjuvant trastuzumab in HER2 positive women with operable breast cancer
Program Number: OT-13-03 - A prospective, randomized, multicenter, double-blinded, placebo-controlled Phase III trial of the HER2/neu peptide GP2 + GM-CSF versus bacteriostatic saline/WFI placebo as adjuvant therapy after any trastuzumab-based therapy in HER2-positive women with operable breast cancer