Switzerland-based Roche has revealed new data from the phase III FeDeriCa study that indicated that the investigational fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab), administered by subcutaneous injection in combination with intravenous chemotherapy, showcased non-inferior levels of Perjeta in the blood (pharmacokinetics) and comparable efficacy and safety to standard intravenous infusions of Perjeta plus Herceptin and chemotherapy in eligible people with HER2-positive early breast cancer (eBC), it was reported on Friday.

The new data is to be revealed in a spotlight session at the 2019 San Antonio Breast Cancer Symposium in Texas, US.

The FeDeriCa study met its primary endpoint, with subcutaneous administration of the fixed-dose combination demonstrating non-inferior levels of Perjeta in the blood during a given dosing interval (Ctrough) when compared to intravenous administration of Perjeta. The safety profile of the FeDeriCa in combination with chemotherapy was comparable to that of intravenous administration of Perjeta and Herceptin and chemotherapy and no new safety signals were found, including no meaningful difference in cardiac toxicity. The most common adverse events in both arms were alopecia, nausea, diarrhoea and anaemia.