315TiP - HERMIONE: A phase 2, randomized, open label trial comparing MM-302 plus trastuzumab with chemotherapy of physician's choice plus trastuzumab, in an...

Date 10 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Breast Cancer, Metastatic
Presenter Javier Cortes Castan
Citation Annals of Oncology (2016) 27 (6): 68-99. 10.1093/annonc/mdw365
Authors J. Cortes Castan1, S. Verma2, S. Hurvitz3, I.E. Krop4, D. Tripathy5, D.A. Yardley6, M. Dionne7, J. Reynolds7, T. Wickham7, I. Molnar7, K. Miller8
  • 1Medical Oncology, Ramon y Cajal University Hospital, Madrid and Vall d’Hebron Institute of Oncology (VHIO), 08035 - Barcelona/ES
  • 2Medical Oncology, Sunnybrook Odette Cancer Center, Sunnybrook HSC, M4N 3M5 - Toronto/CA
  • 3Hematology/oncology, UCLA Medical Center, Santa Monica, 90404 - Santa Monica/US
  • 4Breast Cancer Treatment Center, Dana Farber Cancer Institute, Boston/US
  • 5Department Of Breast Medical Oncology, MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 6Breast Cancer Research Program, Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville/US
  • 7Development, Merrimack, 02139 - Cambridge/US
  • 8Oncology, Indiana University Melvin and Bren Simon Cancer Center, 46202 - Indianapolis/US

Abstract

Background

Although HER2-targeted therapies such as pertuzumab and ado-trastuzumab emtansine (T-DM1) have improved patient outcomes, treatment resistance typically occurs. MM-302 is a HER2-targeted antibody-liposomal doxorubicin conjugate in development by Merrimack Pharmaceuticals. In a Phase 1 study, patients with HER2-positive metastatic breast cancer (MBC) were treated with MM-302 alone and in combination with trastuzumab with or without cyclophosphamide. MM-302 had an acceptable safety profile, and promising efficacy was observed in patients not previously exposed to an anthracycline.

Trial design

HERMIONE is a randomized Phase 2, two-arm, open-label trial in patients with anthracycline naïve, trastuzumab-, pertuzumab- and T-DM1-pretreated HER2-positive locally advanced breast cancer (LABC)/MBC. Patients are randomized 1:1 to receive MM-302 (30mg/m2, Q3W) plus trastuzumab (6mg/kg, Q3W) or chemotherapy of physician's choice (vinorelbine, capecitabine, or gemcitabine) plus trastuzumab (6mg/kg, Q3W).

Clinical trial identification

NCT02213744

Legal entity responsible for the study

Merrimack Pharmaceuticals

Funding

Merrimack Pharmaceuticals

Disclosure

J. Cortes Castan: Employment: MedSir Consulting/Advisory Role: Genentech, Celgene Ownership Interest: MedSir Honoraria: Genentech, Novartis, Eisai, Celgene. S. Verma: Consulting/Advisory Role: Genentech, Amgen, Novartis, AstraZeneca, Lilly, Eisai Honoraria: Pfizer, Novartis, Genentech, Amgen, Boehringer Ingelheim, Merck. S. Hurvitz: Travel, Accommodations, Expenses: Boehringer Ingelheim, Novartis, Genentech, Lilly, Pfizer, Bayer Honoraria: Genentech, Novartis, GSK, Boehringer Ingelheim, Sanofi, Pfizer, Amgen, OBI, Puma, Dignitana, Bayer, Biomarin, Lilly, Merrimack.

I.E. Krop: Vertex: employment of immediate family Travel/Accommodations/Family: Bayer Ownership Interest: Vertex Research Funding: Genentech. D. Tripathy: Consulting/Advisory: Merck, Novartis, Oncoplex, Nextar, Pfizer. Travel/Accommodations/Expenses: Novartis, Merck Research Funding: Genentech, Novartis. M. Dionne, J. Reynolds, T. Wickham, I. Molnar: Employment: Merrimack Stock/Ownership Interest: Merrimack. K. Miller: Consulting/Advisory: Nektar, Clovis, ImClone, Tesaro, Incyte Research Funding: Genentech, Merrimack, ImClone, EntreMed, Taiho, Macrogenics, Medivation, Novartis, Seattle Genetics, Clovis. All other authors have declared no conflicts of interest.