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Study: Kadcyla Not Superior to Herceptin and Chemotherapy for PFS in HER2-Positive Breast Cancer

But MARIANNE trial finds Kadcyla treatment options non-inferior

Two treatment options using trastuzumab emtansine (Kadcyla, Roche) did not help people with previously untreated, advanced HER2-positive breast cancer live significantly longer without the disease worsening compared with treatment using trastuzumab (Herceptin, Roche) plus taxane chemotherapy, the phase III MARIANNE study found.

Roche has announced top-line results of the MARIANNE study, which evaluated three HER2-targeted regimens — trastuzumab emtansine plus pertuzumab (Perjeta, Roche), trastuzumab emtansine alone, and trastuzumab plus taxane chemotherapy — in this patient population. The study showed the three regimens led to progression-free survival (PFS) for a similar amount of time, meeting its non-inferiority endpoint as assessed by an Independent Review Committee (IRC). However, neither trastuzumab emtansine-containing treatment arm significantly improved PFS compared to trastuzumab and chemotherapy.

Adverse events observed in the two experimental arms of the study were generally consistent with those seen in previous studies of Kadcyla and/or Perjeta.

In their approved uses for advanced HER2-positive breast cancer, Kadcyla and Perjeta have been shown to extend survival. Kadcyla is approved for people with previously treated disease (second and later lines). Perjeta is approved in combination with Herceptin and chemotherapy for people with previously untreated disease (first line).

“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,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “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.”

Data from the MARIANNE study will be presented at an upcoming medical meeting. Roche will discuss the data with health authorities.

The MARIANNE study is an international, randomized, multicenter, three-arm study involving 1,095 people with HER2-positive advanced breast cancer — either with inoperable, locally advanced disease that had worsened during or returned after previous treatment, or with disease that had spread to other areas of the body. People with advanced breast cancer at diagnosis and people whose disease had worsened following either neoadjuvant or adjuvant treatment were eligible.

People enrolled in the study received treatment with either a combination of Kadcyla and Perjeta; Kadcyla alone; or Herceptin and either docetaxel or paclitaxel chemotherapy.

The primary endpoint of the MARIANNE study is PFS as assessed by an Independent Review Committee. Secondary endpoints include overall survival, response rate, and the incidence of adverse events. Differences 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.

Kadcyla is an antibody-drug conjugate (ADC), combining two anticancer properties: the HER2-targeting properties of trastuzumab (the active ingredient in Herceptin) and the cytotoxic chemotherapy agent DM1. In Kadcyla, trastuzumab and DM1 are joined together using a stable linker to deliver DM1 directly to HER2-positive cancer cells. Roche licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.

Source: Roche; December 19, 2015.

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