Roche has announced that its antibody drug conjugate Kadcyla cut the risk of disease recurrence when given after neoadjuvant treatment and surgery to certain breast cancer patients with residual disease.
The Phase III KATHERINE study met its primary endpoint, showing Kadcyla (trastuzumab emtansine) alone significantly reduced the risk of disease recurrence or death compared to Herceptin (trastuzumab), when used as adjuvant treatment in people with HER2-positive early breast cancer.
Also of note, no new safety signals were revealed by the trial, the Swiss drugmaker noted.
Sandra Horning, Roche’s chief medical officer and head of global product development, said the findings are highly encouraging and that the firm now intends to enter regulatory discussions “with the goal of bringing this new treatment option to patients as soon as possible.”
Kadcyla is currently the only antibody drug conjugate approved as a single agent in 104 countries, including the US and EU, for the treatment of people with HER2-positive metastatic breast cancer who have previously received Herceptin and taxane chemotherapy, separately or in combination.
It is hoped that results from the KATHERINE trial will pave the way for the drug’s use earlier in the breast cancer treatment pathway.
Full data from the trial are to be presented at the 2018 San Antonio Breast Cancer Symposium on in December.