Date: 2013-09-28
Type of information:
phase: 3
Announcement: results
Company: Roche (Switzerland)
Product: Kadcyla® (trastuzumab emtansine (T-DM1)
Action mechanism: antibody drug conjugate (ADC). Because a stable linker is used, the ADC largely remains intact outside the cancer cell, with the cytotoxic agent in an inactive state until it enters the cancer cell, thereby minimising exposure of normal cells to the chemotherapy. The humanized monoclonal antibody (trastuzumab) binds to the HER2-positive cancer cells, and is thought to block out of control signals that contribute to cancer growth and survival while also calling on the body’s immune system to attack the cells. After binding, trastuzumab emtansine (T-DM1) is internalized into those cancer cells, DM1 containing metabolites of the conjugate specifically destroy the cells.
Disease: advanced HER2-positive breast cancer (metastatic or locally recurrent unresectable) who have received at least two prior treatments including Herceptin, lapatinib and a taxane
Therapeutic area: Cancer - Oncology
Country:
Trial
details: TH3RESA is a phase III randomised, open-label study comparing Kadcyla to the physician's choice of treatment in approximately 600 people with advanced HER2-positive breast cancer (metastatic or locally recurrent unresectable) who have received at least two prior treatments including Herceptin, lapatinib and a taxane. The co-primary endpoints are investigator-assessed PFS and OS. The secondary endpoints include objective response rate and safety profile.
Latest
news: * On September 28, 2013, Roche has announced that Kadcyla® (trastuzumab emtansine) significantly extended the time people with advanced HER2-positive breast cancer (metastatic and unresectable locally advanced/recurrent) lived without their disease worsening (progression-free survival [PFS], a co-primary endpoint) compared to people who received a treatment of their physician’s choice in an open-label phase III study called TH3RESA. The data also showed the risk of disease worsening or death was reduced by 47 percent for people who received Kadcyla® (HR=0.528, P<0.0001). Data for overall survival, the other co-primary endpoint, are not yet mature. No new safety signals were observed with Kadcyla®. The study enrolled people with advanced HER2-positive breast cancer who had progressed despite prior treatment with at least two prior HER2-targeted medicines. It randomised people to receive either treatment with Kadcyla® or a treatment of their physician’s choice. Eighty percent of people treated with physician’s choice received a regimen containing Herceptin (trastuzumab). The late-breaking TH3RESA data will be presented at the European Cancer Congress (ECC), by Dr Hans Wildiers, University Hospital Leuven, Gasthuisberg, Belgium.Kadcyla ®recently received a positive opinion from the European Union’s Committee for Medicinal Productsfor Human Use (CHMP) as a single agent, for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. A European Commission decision on EU marketing approval is expected by the end of the year. In February 2013, Kadcyla was approved by the FDA for the treatment of people with HER2-positive mBC who have received prior treatment with Herceptin and a taxane chemotherapy and have either already received treatment for metastatic cancer, or have had their early-stage cancer come back during or within six months of completing a course of treatment following surgery.
