FeDeriCa clinical trial results : Phase 3 trial in HER2-positive breast cancer meets primary endpoint

FeDeriCa clinical trial results : Roche’s Genentech reported that the phase 3 FeDeriCa study evaluating the investigational fixed-dose combination (FDC) of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase in HER2-positive breast cancer met its primary endpoint.

The Perjeta and Herceptin combination, which was subcutaneously injected in combination with intravenous (IV) chemotherapy, showed non-inferior levels of Perjeta in the blood (pharmacokinetics) in comparison to standard IV infusion of Perjeta plus Herceptin and chemotherapy in patients with HER2-positive early breast cancer (eBC).

The safety profile of Perjeta and Herceptin FDC was in line with that of the two drugs injected intravenously.

FeDeriCa clinical trial results of of Perjeta and Herceptin

FeDeriCa clinical trial results : Genentech’s fixed dose subcutaneous combination of Perjeta and Herceptin shows non-inferiority to intravenous formulations in HER2-positive breast cancer. Photo courtesy of F. Hoffmann-La Roche Ltd.

Commenting on the FeDeriCa clinical trial results, Sandra Horning – chief medical officer and head of Global Product Development at Genetech, said: “With this single injection under the skin, people with HER2-positive breast cancer receiving Perjeta and Herceptin can have a faster treatment option.

“Our medicines have helped millions of people living with HER2-positive breast cancer and this latest development is particularly exciting as, for the first time, we have combined two therapeutic antibodies as a single subcutaneous formulation.”

According to Genetech, the subcutaneous administration of the fixed-dose combination of Perjeta and Herceptin takes nearly eight minutes for the initial loading dose, and around five minutes for each subsequent maintenance dose. This is in comparison to nearly 150 minutes for infusion of a loading dose of the two drugs using the standard IV formulations, and 60-150 minutes for subsequent maintenance infusions for the Perjeta and Herceptin combination.

Genetech said that full data from the FeDeriCa clinical study will be presented at an upcoming medical meeting and to health authorities across the world.

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