Halozyme Therapeutics today announced positive endpoint results from its phase III intravenous chemotherapy trial.
Genentech’s FeDeriCa study used Halozyme’s Enhanze drug-delivery technology for subcutaneous administration of a fixed-dose combination of pertuzumab (Perjeta) and trastuzumab (Herceptin), in combination with intravenous chemotherapy. The results showed non-inferior levels of Perjeta in the blood compared to standard IV infusion with Herceptin in chemotherapy 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,” president & CEO Helen Torley said in a news release. “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.”
A fixed-dose combination of Perjeta and Herceptin through subcutaneous administration takes eight minutes for the initial loading dose and about five minutes for each subsequent maintenance dose, according to Halozyne. Standard IV formulations of the drug combination take about 150 minutes for IV administration and 60-150 minutes for subsequent maintenance doses.
The study also showed the safety profile of the drug combination was consistent with the safety profile of IV-administered Perjeta and Herceptin.