MARIANNE is an international, multicenter, randomized, three-arm study comprising 1,095 patients with advanced HER2-positive breast cancer. Patients enrolled had either inoperable locally advanced disease that had worsened during or returned after previous treatment, or metastases.
The study assessed the feasibility of three different regimens targetting HER2 in people with previously untreated (first-line) advanced HER2-positive breast cancer. Patients enrolled in the study received one of the three composites: Kadcyla (ado-trastuzumab emtansine) plus Perjeta (pertuzumab), Kadcyla alone, and Herceptin (trastuzumab) plus either docetaxel or paclitaxel chemotherapy.
An Independent Review Committee assessed progression-free survival (PFS), the study’s primary endpoint. Overall survival, response rate and the incidence of adverse events were all secondary endpoints. Variations in these endpoints were assessed in each of the Kadcyla-containing treatment arms compared to the Herceptin plus chemotherapy arm, and also between the two Kadcyla-containing arms.
Results from MARIANNE trial showed that all the three regimens were feasible in progression-free survival (PFS) for a similar amount of time.
In a recent news release, Sandra Horning, M.D., chief medical officer and head of Global Product Development said, “Over the past 30 years, we have made significant progress in treating one of the most aggressive forms of advanced breast cancer with medicines that extend patients’ lives across the course of their disease. In this study, we had hoped to show improvement in progression-free survival without the use of traditional chemotherapy in the first-line treatment of patients with advanced HER2-positive breast cancer. While MARIANNE didn’t achieve this result, we will continue to study these medicines, as well as investigational treatments for other types of breast cancer, with the goal of improving outcomes for patients.” Dr. Horning added.
In their approved uses for advanced HER2-positive breast cancer, Kadcyla and Perjeta have been shown to extend survival.
Results from the MARIANNE trial revealed, however, that none of the Kadcyla-containing regimen arms significantly improved PFS compared to Herceptin plus chemotherapy. Additionally, the researchers observed side effects in the two experimental arms of the study consistent with those seen in previous studies of Kadcyla and/or Perjeta.
Results from the MARIANNE study will be presented at an upcoming medical meeting. Moreover, Roche and Genentech will discuss these results with health authorities.