MARIANNE Study of HER2+ Metastatic Breast Cancer: Trastuzumab Emtansine With or Without Pertuzumab vs Trastuzumab Plus Taxane

MedicalResearch.com Interview with:

Edith Perez, MD Vice President and Head of U.S. Medical Affairs Genentech BioOncology

Dr. Edith Perez

Edith Perez, MD
Vice President and Head of U.S. Medical Affairs
Genentech BioOncology

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: MARIANNE was designed to evaluate three HER2-targeted regimens in previously untreated (first-line) HER2-positive metastatic breast cancer (Kadcyla alone, Kadcyla plus Perjeta, Herceptin plus chemotherapy). The study met its non-inferiority endpoint, showing similar progression-free survival (PFS) among the three treatment arms. However, neither Kadcyla-containing treatment arm significantly improved PFS compared to Herceptin and chemotherapy.

MedicalResearch.com: What should readers take away from your report?

Response: In the MARIANNE study, we had hoped to show improvement in PFS without the use of traditional chemotherapy in people with previously untreated HER2-positive metastatic breast cancer. While the study didn’t achieve this outcome, we continue to study Kadcyla and Perjeta, as well as investigational treatments for other types and stages of breast cancer, with the goal of improving outcomes for patients

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Over the past 30 years, we’ve made significant progress in treating HER2-positive metastatic breast cancer — one of the most aggressive forms of breast cancer — with medicines that extend patients’ lives across the course of their disease. We are continuing to evaluate the data from MARIANNE to better understand potential reasons for these results and remain committed to helping people with breast cancer. We also continue to study Kadcyla and Perjeta, as well as investigational treatments for other types of breast cancer, in various settings and combinations.

MedicalResearch.com: Is there anything else you would like to add?

Response: The results of the MARIANNE study do not impact the FDA-approved uses of Perjeta or Kadcyla for HER2-positive metastatic breast cancer, where each has been shown to extend survival. Kadcyla has been shown to help people with previously treated HER2-positive metastatic breast cancer live nearly six months longer compared to lapatinib and Xeloda (capecitabine) (median overall survival [OS]: 30.9 months vs. 25.1 months); and the combination of Perjeta, Herceptin and chemotherapy has been shown to help people with previously untreated HER2-positive metastatic breast cancer live nearly five years, the longest survival observed to date in a clinical study of people with this aggressive type of advanced breast cancer (median PFS: 18.5 months vs. 12.4 months; median OS: 56.5 months vs. 40.8 months).

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Trastuzumab Emtansine With or Without Pertuzumab Versus Trastuzumab Plus Taxane for Human Epidermal Growth Factor Receptor 2–Positive, Advanced Breast Cancer: Primary Results From the Phase III MARIANNE Study
Edith A. PerezCarlos BarriosWolfgang EiermannMasakazu ToiYoung-Hyuck ImPierfranco ConteMiguel MartinTadeusz PienkowskiXavier PivotHoward Burris IIIJennifer A. PetersenSven StanzelAlexander StrasakMonika PatrePaul EllisEdith A. Perez, Mayo Clinic, Jacksonville, FL; Howard Burris III, Sarah Cannon Research Institute and Tennessee Oncology, Nashville, TN; Jennifer A. Petersen, Genentech, South San Francisco, CA; Carlos Barrios, Pontifícia Universidade Católica do Rio Grande do Sul School of Medicine, Porto Alegre, Brazil; Wolfgang Eiermann, Interdisciplinary Oncology Center, Munich, Germany; Masakazu Toi, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Young-Hyuck Im, Samsung Medical Centre, Seoul, Korea; Pierfranco Conte, University of Padova and Istituto Oncologico Veneto, Padova, Italy; Miguel Martin, Facultad de Medicina, Universidad Complutense, Madrid, Spain; Tadeusz Pienkowski, Postgraduate Medical Education Center, Warsaw, Poland; Xavier Pivot, University Hospital Jean Minjoz, Besançon, France; Sven Stanzel, Alexander Strasak, Monika Patre, F. Hoffmann-La Roche, Basel, Switzerland; and Paul Ellis, Guys Hospital and Sarah Cannon Research Institute, London, United Kingdom.
Journal of Clinical Oncology 0 0:0
http://ascopubs.org/doi/abs/10.1200/JCO.2016.67.4887

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