Injectable Herceptin set to transform breast cancer care, says Roche

Data from the Phase III HannaH trial presented last Friday at the European Breast Cancer Conference, Vienna, Austria, could mean that women living with HER2-positive early stage breast cancer may soon be able to receive Herceptin (trastuzumab) in approximately five minutes via a subcutaneous (SC) injection instead of the current 30 minute intravenous (IV) infusion.

Herceptin is the standard of care for HER2-positive early-stage breast cancer and is a blockbuster drug from Swiss drug major Roche (ROG: SIX), which generated sales of 5.23 billion Swiss francs ($5.7 billion) for the company in 2011, with turnover up 9% year-on-year.

The neoadjuvant HannaH trial compared Herceptin SC formulations with Herceptin IV given to women with untreated HER2-positive early stage breast cancer, confined to the breast and regional lymph nodes. The study had a positive outcome, meeting its primary endpoint of “non-inferiority” for pharmacokinetics and pathological complete response rate (pCR). The results showed that, in 45.4% of patients receiving the SC formulation the tumor was completely eliminated, referred to as pathological complete response (pCR). The pCR for patients who received the IV formulation was 40.7%, and there were no new or unexpected safety concerns with the SC formulation.