Halozyme announced the global phase III FeDeriCa study conducted by Genentech, a member of the Roche Group, met its primary endpoint. The FeDeriCa study investigated a fixed-dose combination of pertuzumab (Perjeta®) and trastuzumab (Herceptin®) for subcutaneous administration using Halozyme's ENHANZE® drug delivery technology in combination with intravenous chemotherapy. The study results demonstrated non-inferior levels of Perjeta® in the blood (pharmacokinetics) compared to standard intravenous (IV) infusion of Perjeta® plus Herceptin® and chemotherapy in patients with HER2-positive early breast cancer.
"The results of the phase III FeDeriCa study represent an important development for our ENHANZE® drug delivery technology," said Dr. Helen Torley, President and CEO. "This is the first study to combine two therapeutic antibodies as a single fixed-dose subcutaneous formulation utilizing our ENHANZE® technology, thereby providing patients with HER2-positive breast cancer the possibility of a faster treatment option."
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Subcutaneous administration of the fixed-dose combination of Perjeta® and Herceptin® is approximately 8 minutes for the initial loading dose and approximately 5 minutes for each subsequent maintenance dose. Intravenous administration is approximately 150 minutes for the loading dose of Perjeta® and Herceptin® using standard IV formulations and between 60-150 minutes for subsequent maintenance infusions for the combination.
The study also demonstrated that the safety profile of the fixed dose subcutaneous combination of Perjeta® and Herceptin® was consistent with the safety profile of Perjeta® and Herceptin® administered intravenously.
Full data from the FeDeriCa study will be submitted for presentation at an upcoming medical meeting and to health authorities worldwide, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Halozyme's proprietary ENHANZE® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.