Positive results from Roche's Phase 3 HannaH trial for HER2-positive early breast cancer

Oct 18 2011

Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the diabetes, cancer, dermatology and drug delivery markets, today announced that the Phase 3 HannaH trial, conducted by Roche, showed that women with HER2-positive early breast cancer who received a new, investigational subcutaneous (SC) injection of Herceptin® (trastuzumab), experienced comparable results to Herceptin given as an intravenous (IV) infusion. The SC administration takes around 5 minutes to administer whereas the IV formulation (the current standard) takes around 30 minutes to infuse. Since the subcutaneous administration is an injection under the skin it may allow patients to spend less time in hospital receiving their treatment versus the intravenous method. The ready to use formulation may also significantly reduce pharmacy time as no medicine preparation time is required.

"We are very pleased to see this important program achieve success in a Phase 3 pivotal clinical trial," said Gregory Frost, Ph.D., Halozyme's president and CEO. "The convenience of subcutaneous administration may provide another option for women living with early breast cancer."

No new safety signals were observed and adverse events were overall consistent with Herceptin IV. Data from the trial will be submitted for presentation at an upcoming medical meeting and will support a marketing application to regulatory authorities in the European Union in 2012.

Roche has additional ongoing trials of a subcutaneous formulation of MabThera® (rituximab), using Enhanze™ Technology in patients with CD20+ non-Hodgkin's lymphoma (NHL) and Chronic Lymphocytic Leukaemia (CLL).