Roche Cancer Drug Shows No Added Benefit With Longer Use

Roche Holding AG’s Herceptin breast-cancer medicine didn’t help women more when treatment was extended from one year to two in a company-sponsored trial, scuttling chances for a $1 billion-a-year boost in sales.

Meanwhile, a second trial that sought to cut treatment to six months proved not to be a clear-cut failure, with a doctor from the Roche-sponsored two-year trial saying that some patients may eventually benefit from a shorter course of the $54,000-a-year drug.

The studies presented back-to-back today at the European Society for Medical Oncology’s Vienna meeting didn’t end a debate over the best length of time to use Herceptin.

“There is a strong suggestion that there are some patients who will do just as well with the shorter duration,” said Richard Gelber, a Harvard Medical School professor and an author of the Roche study, at a press conference. “If we stop all the research now, we will never know who they are.”

Women who took Herceptin for two years after surgery and chemotherapy were no less likely to relapse and lived just as long as those on the drug for the current standard of a year, according to results of the Roche-sponsored study, dubbed Hera and conducted by the research consortium Breast International Group. Exactly the same number of women died or relapsed in both groups.

Best Duration?

The two-year trial should put the longer treatment hypothesis to rest, said Christoph Zielinski, chairman of the clinical division of oncology at Medical University Vienna. He wasn’t involved in either study.

That study was the continuation of one of the trials that helped establish Herceptin as a standard of care in 2005. The drug helps women with a gene mutation that results in extra proteins known as HER2 being generated from their cancer cells.

After a median eight years of follow-up, Herceptin was still helping to extend lives and prevent cancer from returning, the Breast International Group said.

“This study provides evidence and reassurance that one year of treatment is optimal,” Sandra Horning, head of oncology research for Roche, said in a telephone interview.

Roche rose 2.3 percent to close at 179.80 Swiss francs.

Roche Statement

Roche also issued a statement saying today’s second trial, dubbed Phare and run by the French National Cancer Institute, also confirmed a year’s treatment as optimal. Women who got six months of Herceptin were 28 percent more likely to die or have their breast cancer recur than those who got a year, the drugmaker said.

The Roche statement isn’t accurate, said Xavier Pivot, an oncologist of the University of Franche-Comte who led the French study.

That’s because while the Phare trial showed a trend toward a year being better than six months, the data wasn’t statistically significant. So while the investigators couldn’t say that six months are just as good as as a year, they also couldn’t say a year is better.

Gelber, the senior biostatistician on Roche’s own trial, agreed that the French study was inconclusive.

Changing Data

Phare hasn’t been going on for long enough for the data to be mature, Gelber said. He pointed to a Power Point slide with data that had changed in the few weeks between when the French researchers filed the slide with ESMO and when they presented it to reporters. That means the data is still developing, he said, arguing that doctors should to wait at least a year before telling the public that six months’ treatment is worse.

Billions of dollars are at stake as doctors and health systems interpret today’s data.

Roche may have stood to gain another $1 billion in revenue had the two-year results turned out differently, according to an estimate from Jefferies Group Inc. analysts. The Basel, Switzerland-based drugmaker made about 5.3 billion Swiss francs ($5.6 billion) in sales last year from Herceptin, its third-biggest-selling drug.

If researchers can show that six months of treatment are just as good as or better than a year, it may encourage governments to cut the amount of time they pay for the drug. A one-year course of Herceptin costs about 24,600 pounds ($39,700) to 28,000 pounds in England. It costs $54,000 in the U.S.

Earnings Effect

If half the doctors in the European Union switch to the shorter treatment period, Roche’s earnings per share may drop 2 percent, Sanford C. Bernstein & Co. analysts estimated.

Meanwhile, in markets where 12 months of Herceptin is too expensive, “the data suggest that if you can treat twice as many women for six months, you had better give six months instead of denying treatment,” Gelber said.

Analysis of Phare will continue. The French team will look more closely at subgroups of patients in a presentation scheduled for December, Pivot said.

Researchers in the U.K. and Finland are also studying whether shorter treatment with Herceptin may provide patients just as much benefit with fewer side effects. Unwanted effects of the cancer drug may include flu-like symptoms and heart damage.

“I think the only sensible thing to do is to continue,” said Helena Earl, an oncologist at Addenbrooke’s Hospital in Cambridge and one of the leaders of Persephone, the U.K. six-month trial. “We need more patients to be clear.”

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