Roche's Kadcyla reduced the risk of disease recurring in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment

F. Hoffmann-La Roche Ltd / Roche's Kadcyla reduced the risk of disease recurring in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• Phase III KATHERINE study shows Kadcyla significantly improved invasive disease-free survival compared to Herceptin in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment

Data will be submitted to health authorities around the world, including the US Food and Drug Administration and European Medicines Agency

Results will be presented at the 2018 San Antonio Breast Cancer Symposium in December

Basel, 15 October 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the phase III KATHERINE study met its primary endpoint, showing Kadcyla (trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival, iDFS) compared to Herceptin (trastuzumab) as an adjuvant (after surgery) treatment in people with HER2-positive early breast cancer (eBC) who have residual disease (pathological invasive residual disease in the breast and/or axillary nodes) present following neoadjuvant (before surgery) treatment. The safety profile of Kadcyla in the KATHERINE study was consistent with previous clinical trials and no new safety signals were identified. ^[1,2]

"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," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "We look forward to discussions with regulatory authorities with the goal of bringing this new treatment option to patients as soon as possible."

Full results will be submitted to health authorities around the world, and will be presented at the 2018 San Antonio Breast Cancer Symposium on Wednesday 5 December at 11.00 am CST.

The KATHERINE trial investigated a population of people with HER2-positive eBC who did not achieve a pathological complete response to neoadjuvant treatment. This state of residual disease is associated with a worse prognosis.^[3,4]