Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster session 03

353TiP - Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01

Date

21 Oct 2023

Session

Poster session 03

Topics

Clinical Research;  Targeted Therapy;  Immunotherapy

Tumour Site

Breast Cancer

Presenters

Snehal Patel

Citation

Annals of Oncology (2023) 34 (suppl_2): S278-S324. 10.1016/S0923-7534(23)01258-9

Authors

S. Patel1, J. Thompson1, M. Patel1, F.J. Daugherty1, M. Rimawi2

Author affiliations

  • 1 Clinical And Regulatory, Greenwich LifeSciences, Inc., 77477 - Stafford/US
  • 2 Hematology And Oncology, Baylor College of Medicine, 77030 - Houston/US

Resources

Login to get immediate access to this content.

If you do not have an ESMO account, please create one for free.

Abstract 353TiP

Background

GP2 is a biologic nine amino acid peptide of the HER2/neu protein delivered in combination with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) that stimulates an immune response targeting HER2/neu expressing cancers, the combination known as GLSI-100. In a prospective, randomized, single-blinded, placebo-controlled, multicenter phase IIb study, no recurrences were observed in the HER2+ population after 5 years of follow-up, if the patient was treated with GLSI-100, survived, and was followed for more than 6 months (p = 0.0338). Immunotherapy elicited a potent response measured by skin tests and immunological assays. Of the 146 patients that have been treated with GLSI-100 over 4 clinical trials, GLSI-100 was well-tolerated and no serious adverse events observed were considered related to the immunotherapy.

Trial design

This phase III trial is a prospective, randomized, double-blinded, multi-center study. After 1 year of trastuzumab-based therapy, 6 intradermal injections of GLSI-100 or placebo will be administered over the first 6 months and 5 subsequent boosters will be administered over the next 2.5 years. The participant duration of the trial will be 3 years treatment plus 1 additional year follow-up. Approximately 498 patients will be enrolled. To detect a hazard ratio of 0.3 in invasive breast cancer free survival (IBCFS), 28 events will be required. An interim analysis for superiority and futility will be conducted when at least 14 events have occurred. This sample size provides 80% power if the annual rate of events in placebo patients is 2.4% or greater. Up to 100 non-HLA-A*02 subjects will be enrolled in an open-label arm. The patient population is defined by these key eligibility criteria: 1) HER2/neu positive and HLA-A*02 and 2) Residual disease or High risk pCR (Stage III at presentation) post neo-adjuvant therapy. The trial objectives are to: 1) Determine if GP2 therapy increases IBCFS, 2) Assess the safety profile of GP2, and 3) Monitor immunologic responses to treatment and assess relationship to efficacy and safety. The study has been initiated in the US with plans to open in Europe.

Clinical trial identification

NCT05232916.

Editorial acknowledgement

Legal entity responsible for the study

Greenwich LifeSciences. Inc.

Funding

Greenwich LifeSciences, Inc.

Disclosure

S. Patel: Financial Interests, Personal, Ownership Interest: Greenwich LifeSciences, Inc.; Financial Interests, Personal, Stocks/Shares: Greenwich LifeSciences, Inc.; Financial Interests, Personal, Member of Board of Directors: Greenwich LifeSciences, Inc.; Financial Interests, Personal, Officer: Greenwich LifeSciences, Inc.; Financial Interests, Personal, Full or part-time Employment: Greenwich LifeSciences, Inc.. J. Thompson: Financial Interests, Personal, Ownership Interest: Greenwich LifeSciences, Inc.; Financial Interests, Personal, Stocks/Shares: Greenwich LifeSciences, Inc.; Financial Interests, Personal, Officer: Greenwich LifeSciences, Inc.; Financial Interests, Personal, Full or part-time Employment: Greenwich LifeSciences, Inc.. M. Patel: Financial Interests, Personal, Ownership Interest: Greenwich LifeSciences, Inc.; Financial Interests, Personal, Stocks/Shares: Greenwich LifeSciences, Inc.; Financial Interests, Personal, Full or part-time Employment: Greenwich LifeSciences, Inc.. F.J. Daugherty: Financial Interests, Personal, Ownership Interest: Greenwich LifeSciences, Inc.; Financial Interests, Personal, Stocks/Shares: Greenwich LifeSciences, Inc.; Financial Interests, Personal, Member of Board of Directors: Greenwich LifeSciences, Inc.; Financial Interests, Personal, Officer: Greenwich LifeSciences, Inc.; Financial Interests, Personal, Full or part-time Employment: Greenwich LifeSciences, Inc.. M. Rimawi: Other, Personal, Speaker’s Bureau: Daiichi Sankyo, Genentech, Macrogenics, Seattle Genetics; Other, Personal, Other, Contracted Research: F. Hoffmann-La Roche Ltd., Pfizer; Other, Personal, Principal Investigator: Greenwich LifeSciences, Inc.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.