Roche’s Herceptin phase III trial shows positive results
Halozyme Therapeutics has reported that the phase III 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.
HannaH is a phase III, open-label trial involving 596 women with HER2-positive early breast cancer. The trial was designed to compare trastuzumab concentration in the blood (pharmacokinetics), efficacy (pathologic complete response) and safety of Herceptin SC to that of Herceptin IV.
The trial met its co-primary endpoints that were trastuzumab concentration in the blood (serum concentrations) and efficacy. Secondary endpoints included event-free survival and overall survival. In the trial the most common side effects seen were infections and abnormal blood counts (anaemia and low white blood count) similar to other trials with chemotherapy and Herceptin IV. No new safety signals were observed and adverse events were overall consistent with Herceptin IV.