Roche Holding, a renowned Swiss healthcare company working in pharmaceuticals and diagnostics, reportedly announced novel data from its Phase 3 FeDeriCa trial. The trial showed the investigational FDC (fixed-dose combination) of pertuzumab (Perjeta®) and trastuzumab (Herceptin®), dosed by subcutaneous (SC) injection together with IV (intravenous) chemotherapy, showcased non-inferior Perjeta levels in blood (pharmacokinetics).

It also demonstrated comparable safety and efficacy to standard IV infusions of Herceptin plus Perjeta along with chemotherapy in patients suffering from HER2-positive eBC (early breast cancer).  

These novel data, from a key study analysis of the FeDeriCa trial, would be presented during a spotlight session at the 2019 SABCS (San Antonio Breast Cancer Symposium). SABCS is being held in Texas, US.

SC administration of FDC takes about eight minutes for the primary loading dose and about five minutes for every subsequent maintenance dose. This dose is compared to about 150 minutes needed for infusion of loading dose of Herceptin and Perjeta utilizing the standard IV formulations, and between 60 to 150 minutes for following maintenance infusions of two medicines.

Head of Global Product Development and Roche’s Chief Medical Officer, Levi Garraway, M.D., Ph.D. stated that this fixed-dose subcutaneous combination is capable of providing a less invasive and quicker method of administration for patients suffering from HER2-positive breast cancer, being treated with Herceptin and Perjeta.

Garraway further added that this is the first time that the company has combined two of its targeted antibodies as one subcutaneous injection which can be dosed in just minutes.

The safety profile of fixed-dose combination together with chemotherapy was comparable to IV administration of Herceptin plus Perjeta and chemotherapy. Also, no new safety signals were identified, which also includes no significant difference within cardiac toxicity. The most common adverse events found in both arms were nausea, alopecia, anemia, and diarrhea.

In earlier studies, subcutaneous administration has been shown to be highly preferred by most of the patients in comparison with IV administration of the very same medicine. The most common reason behind this was that this dosage needed less time inside the clinic.

Source credit: https://www.roche.com/media/releases/med-cor-2019-12-12.htm