An easily injectable formulation of Roche’s breast cancer drug Herceptin has been shown to be as safe and effective as the intravenous version now available.

The new version of Herceptin (trastuzumab), available via subcutaneous (SC) injection, reduces the drug’s administration time from 30 to five minutes.

UK patients who are eligible for the SC formulation could be treated more rapidly, freeing up capacity in hospital chemotherapy facilities.

The HannaH trial compared Herceptin SC with Herceptin IV in 596 women with untreated HER2-positive early-stage breast cancer.

The study met its primary endpoint of ‘non-inferiority’ for pharmacokinetics and success in tumour eradication, and there were no new safety concerns.

Breast cancer is the most common cancer in the UK, with more than 48,000 newly diagnosed patients and 12,000 fatalities in 2008.

Herceptin is a targeted drug that blocks the function of HER2, a protein produced by a gene with cancer-causing potential. It uses the body’s immune system to destroy the tumour cells.

In 15% of women with breast cancer, increased quantities of the HER2 receptor are present on the tumour cells. HER2-positive breast cancer is associated with relatively poor survival rates.

Herceptin is indicated in Europe for the treatment of early-stage and metastatic breast cancer and metastatic gastric cancer. It is currently approved in an IV formulation only.

Herceptin SC uses a specialised technology to break down the skin barrier to drugs, enabling the subcutaneous injection of large volumes of medication.

Dr Mark Verrill, Consultant Medical Oncologist at Freeman Hospital, Newcastle Upon Tyne, commented: “The result of the HannaH trial is good news, particularly for patients. Herceptin is the standard of care, so the ability to deliver the drug in approximately five minutes without the need to secure intravenous access makes the treatment far more convenient.

“Aside from the benefit for patients, Herceptin SC has the potential to ease capacity at busy chemotherapy day units and may facilitate treatment close to home, resonating with the Cancer Reform Strategy.”

Roche is the world’s largest biotechnology firm, specialising in the development of personalised medicines for oncology, virology, inflammation, metabolism and CNS disorders.

GlaxoSmithKline’s breast cancer drug Tyverb (lapatinib) has failed to show a significant increase in disease-free survival (DFS) when used alone in patients with early-stage HER2-positive breast cancer.

The results of the TEACH phase III clinical trial mean that Tyverb (known as Tykerb in the US) is unlikely to succeed as a monotherapy in this indication, though it will continue to be used in combination therapy.

The TEACH trial established that 13% of patients treated with Tyverb following initial surgery or chemotherapy for breast cancer achieved DFS after four years, compared to 17% on placebo.

The trial did not compare Tyverb with Roche’s breast cancer drug Herceptin (trastuzumab). The two drugs were approved by the FDA for use in combination in 2007, and in that indication earned GSK $360 million in 2010.

However, whereas Herceptin has proved successful as a monotherapy, Tyverb has not. In September, GSK abandoned the monotherapy arm of another trial (ALTTO) after concluding that Tyverb was less effective in treating early-stage breast cancer than Herceptin alone.

The TEACH trial is still expected to support the use of Tyverb in combination with Herceptin.

“We are disappointed that the improvement in disease-free survival with lapatinib monotherapy in TEACH did not reach statistical significance,” said Rafael Amado, Senior VP of Oncology Development at GSK.

“Lapatinib combination therapy remains an important treatment option for patients with metastatic HER2-positive breast cancer whose disease has progressed on treatment with trastuzumab-based regimens.”