Halozyme Therapeutics, Inc. issued the following announcement on July 26.
Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that Genentech, a member of the Roche Group, 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 Halozyme's proprietary ENHANZE® drug-delivery technology in combination with chemotherapy.
The global Phase 3 study is investigating the combination as a single fixed-dose in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant and adjuvant settings. The estimated administration time for the initial loading dose of the combination is 7 to 8 minutes and subsequent maintenance doses are approximately 5 minutes.
"We are excited to support the initiation by Genentech of the first Phase 3 study exploring a fixed-dose combination of two therapeutics," said Dr. Helen Torley, president and CEO of Halozyme. "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."
The Phase 3 study follows a Phase 1b clinical trial that assessed the safety, tolerability and pharmacokinetics of the same fixed-dose combination presented at the 2017 San Antonio Breast Cancer Symposium.
Perjeta (pertuzumab) and Herceptin (trastuzumab) are registered trademarks of Genentech, a member of the Roche Group.
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