Genentech's fixed dose subcutaneous combination of Perjeta + Herceptin showed non-inferiority when compared to intravenous formulations for HER2-positive breast cancer

-Genentech, has announced the Phase III FeDeriCa study met its primary endpoint. The study showed a new investigational fixed-dose combination (FDC) of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, demonstrated non-inferior levels of Perjeta in the blood (pharmacokinetics) compared to standard IV infusion of Perjeta plus Herceptin and chemotherapy in people with HER2-positive early breast cancer (eBC).

The safety profile of Perjeta and Herceptin FDC was consistent with that of Perjeta and Herceptin administered intravenously. “With this single injection under the skin, people with HER2-positive breast cancer receiving Perjeta and Herceptin can have a faster treatment option,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development."For the first time, we have combined two therapeutic antibodies as a single subcutaneous formulation.”

SC administration of the FDC takes approximately 8 minutes for the initial loading dose, and approximately 5 minutes for each subsequent maintenance dose. This is compared to approximately 150 minutes for infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions for the combination. Full data from the FeDeriCa study will be submitted for presentation at an upcoming medical meeting and to health authorities around the world.

About the FDC ( Fixed Dose Combination) of Perjeta and Herceptin- The FDC of Perjeta and Herceptin is a new SC formulation that combines pertuzumab and trastuzumab with Halozyme Therapeutics’ Enhanze drug delivery technology. Trastuzumab in the FDC is the same monoclonal antibody in IV Herceptin, and pertuzumab is the same monoclonal antibody in IV Perjeta. The mechanisms of action of Perjeta and Herceptin are believed to complement each other as both bind to the HER2 receptor, but to different places. The combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of the HER signaling pathways. Halozyme’s Enhanze drug delivery technology may enable and optimize SC drug delivery for appropriate co-administered therapeutics. The technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that temporarily degrades hyaluronan - a glycosaminoglycan or chain of natural sugars in the body, to aid in the dispersion and absorption of other injected therapeutic drugs.