The TH3RESA study assessed Kadcyla (ado-trastuzumab emtansine) for the treatment of advanced HER2-positive breast cancer that had progressed despite prior treatment with at least two HER2-targeted medicines. At a minimum, patients must have received Herceptin® (trastuzumab), Tykerb® (lapatinib), and a taxane. The trial included approximately 600 patients who were randomized, on a two-to-one basis, to receive either Kadcyla or a treatment of their physician’s choice. Eighty percent of the patients treated with physician’s choice received a regimen containing Herceptin plus a second agent.
Kadcyla was found to significantly extend duration of progression-free survival (PFS) compared to treatment with physician’s choice (median 6.2 months vs. 3.3 months, respectively) and reduced the risk of disease progression or death by 47 percent (HR=0.528; p<0.0001). In the planned interim analysis, overall survival (OS) favored Kadcyla, but the data are not yet mature. PFS and OS are co-primary endpoints of the trial. No new safety signals were observed with Kadcyla.
Based on the earlier EMILIA Phase III trial, Kadcyla is approved for marketing in several countries, including the US,
“The TH3RESA trial provides further support of improved progression-free survival with Kadcyla in patients with advanced HER2-positive breast cancer,” commented
Kadcyla consists of Roche’s trastuzumab antibody and ImmunoGen’s DM1 cytotoxic agent. The DM1 is attached to the antibody using one of ImmunoGen’s linkers. Roche has global development and commercialization rights for Kadcyla; ImmunoGen is entitled to receive specified milestone payments and royalties on product sales.
Roche is conducting a number of studies assessing Kadcyla for potential additional uses. These include for the first-line treatment of HER2-positive metastatic breast cancer, for early stage HER2-positive breast cancer and for advanced HER2-positive gastric cancer.
Kadcyla®, Herceptin®, and Tykerb® are registered trademarks of their respective owners.
Executive Director, Investor Relations and Corporate Communications
The Yates Network