Roche has reported positive results from the Phase III KATHERINE trial after meeting the study's primary endpoint.
The trial evaluated the efficacy and safety of Kadcyla (trastuzumab emtansine) in comparison with Herceptin (trastuzumab) in treating people with HER2-positive early breast cancer (eBC) with pathological residual disease in the breast and/or axillary lymph nodes following neoadjuvant therapy that included Herceptin and taxane-based chemotherapy.
It included an international, multi-centre, two-arm, randomised, open-label setting.
The primary objective of the KATHERINE study is invasive disease-free survival (iDFS). This refers to the time from randomisation to invasive breast cancer recurrence, or death from any cause.
Secondary objectives comprise disease-free survival and overall survival.
The latest results showed that Kadcyla as a single agent significantly lowered the risk of disease recurrence or death over Herceptin as an adjuvant (after surgery) treatment in the enrolled patients.
They also demonstrated similar safety profile of Kadcyla with those found in previous clinical trials. No new safety signals were observed in the KATHERINE trial.
Roche Global Product Development head and chief medical officer Sandra Horning said: “We look forward to discussions with regulatory authorities with the goal of bringing this new treatment option to patients as soon as possible.”
The company’s Kadcyla is an antibody-drug conjugate (ADC), developed to provide potent chemotherapy directly to HER2-positive cancer cells with an aim to potentially reduce damage to healthy tissue.
Kadcyla features two anti-cancer properties joined together by a stable link.