Genentech has dosed the first patient in a Phase 3 study of a fixed-dose combination of pertuzumab (Perjeta) and trastuzumab (Herceptin) for subcutaneous administration using US-based biotechnology firm Halozyme's proprietary Enhanze drug-delivery technology in combination with chemotherapy.
The Phase 3 study examines the combination as a single fixed-dose in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in both neoadjuvant and adjuvant settings.
The administration time for the initial loading dose of the combination is estimated to be seven to eight minutes, with subsequent maintenance doses being around five minutes.
Halozyme president and CEO Dr. Helen Torley said: "We are excited to support the initiation by Genentech of the first Phase 3 study exploring a fixed-dose combination of two therapeutics."
"For breast cancer patients and healthcare professionals, the approach of administering pertuzumab and trastuzumab subcutaneously in a single injection with ENHANZE offers the potential for a new treatment administration option."
This Phase 3 study comes after the Phase 1b clinical trial that evaluated the safety, tolerability and pharmacokinetics of the same fixed-dose combination.
Perjeta (pertuzumab) and Herceptin (trastuzumab) are registered trademarks of Genentech, a member of the Roche Group.
Halozyme's proprietary Enhanze drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20), which has shown removal of traditional limitations on the volume of biologics that can be delivered subcutaneously.
With the use of rHuPH20, some biologics and compounds that are given intravenously, may also be delivered subcutaneously.
Furthermore, Enhanze technology may also benefit subcutaneous biologics by minimising the requirement for several injections. Studies have shown that this delivery method could reduce healthcare practitioner’s time required for administration, as well as cut down time for drug administration.
Halozyme Therapeutics focuses on developing and commercialising novel oncology therapies that target the tumour microenvironment.