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Roche subcutaneous Herceptin Phase 3 trial yields positive data

Halozyme Therapeutics has announced positive results of Roche's Phase 3 HannaH trial, which tested the efficacy of subcutaneous (SC) injection of Herceptin (trastuzumab) in women with HER2-positive early breast cancer.

HannaH, an open-label trial involving 596 women compared Herceptin given as subcutaneous (SC) injection versus that given as an intravenous (IV) infusion.

Herceptin SC uses Enhanze Technology which enables the injection deliver large volumes of a medication under the skin.

The data showed that SC administration takes around 5 minutes to administer whereas the IV formulation takes around 30 minutes to infuse.

The co-primary endpoints comprised trastuzumab concentration in the blood (serum concentrations) and efficacy, while secondary endpoints included event-free survival and overall survival.