Roche Holding AG said Kadcyla is better than Herceptin in lowering the risk of disease recurrence in early breast cancer patients, meeting the main goal of a late-stage study.
The Swiss drugmaker was studying Kadcyla — a formulation of the active ingredient trastuzumab with chemotherapy agent DM1 — in a phase 3 trial known as Katherine, which enrolled patients with human epidermal growth factor receptor-2 positive, or HER2-positive, early breast cancer who received a primary treatment, such as Herceptin and taxane-based chemotherapy, to help shrink tumors and improve surgical outcomes.
Trastuzumab is also the active ingredient in Roche's blockbuster drug Herceptin.
The study found that Kadcyla was better than Herceptin in reducing the risk of disease recurrence or death when administered in patients who had residual disease following surgery. Results from the study also showed that Kadcyla helped prolong the period in which the patients survived without any signs or symptoms of cancer.
According to Sandra Horning, Roche's chief medical officer and head of global product development, the company will conduct discussions with regulatory authorities for Kadcyla's approval as soon as possible. Doctors could then prescribe Kadcyla as an adjuvant treatment to help eliminate any remaining cancer cells in the body and to help reduce the risk of the disease returning.
Kadcyla, an antibody-drug conjugate which delivers chemotherapy directly to HER2-positive cancer cells and limits damage to healthy tissues, is currently only approved for HER2-positive breast cancer that has spread to other parts of the body after prior treatment with Herceptin and chemotherapy.