2018-10-22| R&DTrials & Approvals

Roche’s breast cancer drug, Kadcyla succeeds phase III trial

by Rajaneesh K. Gopinath
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By Rajaneesh K Gopinath

Approved by the FDA in 2013, Kadcyla is used as a single agent for the treatment of patients with HER2-positive, metastatic breast cancer who previously received Herceptin and a taxane.

On October 15th, Roche announced that the phase III KATHERINE study has met its primary endpoint, which was invasive disease-free survival (iDFS). This international, multi-centre, two-arm, randomised, open-label study showed that, in comparison to Herceptin (trastuzumab), Kadcyla (ado-trastuzumab emtansine) significantly reduced the risk of disease recurrence or death when used as an adjuvant treatment. The results of the study will be presented at the 2018 San Antonio Breast Cancer Symposium scheduled to be held in December.

Kadcyla is an antibody-drug conjugate (ADC) that combines the HER2-targeting property of the recombinant HER2 monoclonal antibody trastuzumab conjugated to the chemotherapy agent maytansinoid DM1 via a nonreducible thioether linkage. While the trastuzumab moiety binds to the tumor cells that overexpress HER2, the DM1 moiety binds to the tubulin of those cells and disrupt microtubule assembly/disassembly dynamics thereby proving detrimental to their growth and proliferation. Kadcyla is the third product of Roche following Herceptin and Perjeta (pertuzumab) that has helped to transform the treatment of HER2-positive breast cancer. At the moment, it is currently the only antibody drug conjugate approved as a single agent in 104 countries, including the US and EU.

Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development expressed her excitement. “We are highly encouraged by these positive results with adjuvant Kadcyla treatment in people with HER2-positive early breast cancer who have residual disease after neoadjuvant therapy. We look forward to discussions with regulatory authorities with the goal of bringing this new treatment option to patients as soon as possible.” she said.





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