Drugs brand boosted by trial data

Roche, the world’s biggest maker of cancer drugs, got a boost as results of trials that will protect sales of its breast cancer drug Herceptin coincided with data showing a new drug in the franchise helped patients live longer.

Results were inconclusive but showed a trend in favour of 12 months’ treatment

Two trials on Roche’s blockbuster Herceptin wiped out a risk that they could have indicated a shorter period of treatment than the current recommendation of one year – a finding that could have cost up to €1.16 billion in sales.

A third trial comparing Roche’s experimental drug TDM-1 with a standard cocktail of drugs in patients with an aggressive form of advanced breast cancer showed the new drug helped patients live more than five months longer.

TDM-1, or trastuzumab emtansine, is an “armed antibody” drug being developed by Roche and Immunogen as a successor to Herceptin, which could be exposed to so-called “biosimilar” generic competition in Europe from around 2015.

Roche released results of a study investigating whether there is a benefit in using Herceptin for two years rather than one, while a separate French study looked whether patients got the same benefit from just six months of Herceptin treatment.

The Roche study found no difference in the rate at which patients’ cancer recurred or in how long patients lived. The French study’s results were inconclusive, in other words they did not show that a shorter treatment was as good.

Data from both trials was presented at the European Society of Medical Oncology (ESMO) conference in Vienna.

Analysts at brokerage Chevreux in London said the overall picture from the two studies was “reassuring for the Herceptin franchise”.

Analysts had said the Swiss firm could lose up to €1.16 billion in sales from the blockbuster drug in the medium term if six months’ treatment had been shown to be just as beneficial.

Herceptin, known generically as trastuzumab, was first approved in 1998 and had 2011 sales of 5.25 billion Swiss francs (€4.25 billion). It is used as a treatment for around a quarter of breast cancer patients who have tumours that generate a protein called HER2, which tends to make their disease more aggressive.

“The key message for 2012 is that one year of treatment with trastuzumab remains the standard of care for HER2-positive early breast cancer patients,” said Richard Gelber, a professor at Harvard Medical School and Dana-Farber Cancer Institute in Boston,US, who led the Roche trial.

Presenting the French study, Xavier Pivot of the University of Franche-Comté in France said the results were “inconclusive” but showed a “trend in favour of 12 months’ treatment”.