New Herceptin-Perjeta Formulation Shows Promising Safety and Pharmacokinetic Profile, Phase 3 Trial Shows

When given together with Herceptin (trastuzumab) at a fixed dose through an under-the-skin (subcutaneous) injection, Perjeta (pertuzumab) reaches levels in the blood in women with HER2-positive breast cancer that is similar to those seen when the medication is administered intravenously, data from a Phase 3 trial shows.

This new mode of administration also is faster than the standard intravenous route, the trial found.

These are the first findings of the global, randomized, open-label, FeDeriCa Phase 3 trial (NCT03493854). The study is being conducted by Genentech, a subsidiary of Roche, at 122 sites worldwide.

FeDeriCa was the first study to investigate the pharmacokinetic properties and safety profile of a subcutaneous fixed-dose combination of Perjeta-Herceptin when administered together with intravenous chemotherapy, in a group of women with HER2-positive breast cancer. Pharmacokinetics is the study of how a drug is absorbed, distributed, metabolized, and eliminated from the body — basically, what the body does to a drug.

The simultaneous administration of both medications through an under-the-skin injection was performed using Halozyme Therapeutics’ ENHANZE proprietary drug delivery technology. It eliminates the limitations traditionally associated with the amount of biologics that can be subcutaneously administered.

New data from FeDeriCa showed the trial met its primary outcome of non-inferiority. The subcutaneous Perjeta reached levels in the blood of study participants similar to those seen when the medication is administered intravenously.

Moreover, this new mode of administration surpassed the dosing speed of the standard intravenous route by far, the results found.

Study findings revealed the initial loading dose of subcutaneous Perjeta-Herceptin takes approximately eight minutes, with an additional five minutes for each subsequent maintenance dose. Conversely, when administered intravenously, the initial loading dose of Perjeta takes approximately 150 minutes, and between 60-150 minutes for each subsequent maintenance dose.

In addition, analyses demonstrated that the safety profile of the new fixed-dose combination of Perjeta-Herceptin was consistent with the safety profile of both medications when administered separately by an intravenous route.

“The results of the Phase 3 FeDeriCa study represent an important development for our ENHANZE drug delivery technology,” Helen Torley, president and CEO of Halozyme Therapeutics, said in a press 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.”

Full data from the trial will be presented at an upcoming meeting, and submitted to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).