Roche $5.7 Billion Tumor Drug Sales Hinge on Rival Tests

After surgery, radiotherapy, chemotherapy, 80 visits to oncologists and more than 300 hours in clinics, Stephanie Butland decided she had had enough cancer treatment for one lifetime.

The British author quit Roche Holding AG (ROG)’s cancer drug Herceptin after half the time it’s normally prescribed.

“I was ready to say, I’m done with cancer now and am back to my life,” Butland said. “I think it’s not uncommon for people to feel that Herceptin is kind of like the straw that breaks the donkey’s back.”

In cutting her treatment short, Butland took a bet that her cancer wouldn’t return. Many more women may be encouraged to do the same after next week’s meeting of the European Society for Medical Oncology, where a French medical team will present the results of a study of whether Herceptin is just as effective at postponing the recurrence of cancer and helping women live longer after six months as it is after one year of treatment, the current standard of care.

Roche will also attend the Vienna event armed with its own test results that may argue for women not cutting their treatment short. The results could, in fact, support a case for doubling treatment to as long as two years.

Billions of dollars are at stake. If the French trial shows six months of treatment are better than a year, it will provide cash-strapped governments with ammunition to trim health-care spending, while causing a hit to Roche’s bottom line. If the Roche tests make a strong case for doubling treatment times, the outcome could be the reverse.

Doubling Treatment

Were doctors around the world to start prescribing Herceptin to post-surgery breast cancer patients for six months instead of a year, it could cost Roche as much as 12 percent of its earnings per share, Tim Anderson, a New York-based analyst for Sanford C. Bernstein & Co., wrote in a note to investors on Sept. 21. If half the doctors in the European Union adopted the shorter treatment period, earnings could drop 2 percent, Anderson said.

“There’s a downside” here for Roche, Pascal Soriot, the company’s former pharma head now set to become chief executive officer of AstraZeneca Plc (AZN), acknowledged to analysts in July.

Yet should the findings go the other way and suggest treatment times be extended, Roche stands to profit handsomely. The Basel, Switzerland-based drugmaker made 5.29 billion Swiss francs ($5.7 billion) in sales last year from Herceptin.

Sales among breast cancer patients who underwent surgery may increase 25 percent -- worth about another $1 billion a year -- if Roche can show two years of Herceptin beat one, analysts from Jefferies Group Inc. estimated in a Sept. 12 report.

Downside for Herceptin

What would be good for Roche’s bottom line would be bad news for governments working to save money as they face financial turmoil. In England, where Butland was treated, Herceptin costs about 24,600 pounds ($39,975) to 28,000 pounds per patient per year. The country’s cost-conscious National Health Service agreed in 2006 to pay for a year’s treatment to help prevent breast cancer from returning after women have surgery.

The debate isn’t about whether Herceptin works. Rather, the trials should help determine whether doctors can achieve the same results with fewer side effects by treating women for a shorter period of time, said Helena Earl, an oncologist at Addenbrooke’s Hospital in Cambridge.

‘Shivering and Exhausted’

Earl is one of the leaders of Persephone, a U.K. trial also comparing six months of Herceptin to one year. The drug often leaves women with flu-like symptoms and is administered through an IV in a hospital or clinic, requiring patients to go back to the doctor for several hours every few weeks.

“I had quite bad flu-like symptoms, shivering, feeling achy,” Butland recalled. “The inside of my nose was always bleeding, and I felt exhausted. I’d get myself picked up, but I’d never feel 100 percent. It got worse with each round of Herceptin.”

Butland writes about her “dance with breast cancer” on a blog called Bah!tocancer. She was first diagnosed in November 2008, stopped Herceptin in 2010 after consulting with her oncologist about the body of evidence hinting that six months’ treatment might be enough, and now describes herself as thriving.

Earl, the University of Cambridge oncologist, recalls the day she squeezed into a lecture hall at the American Society of Clinical Oncology meeting in 2005 to hear the trial results that made Herceptin a standard treatment. Even then, she remembers one of the speakers raising the important question of how long women should take the medicine.

Pragmatic Decision

There’s no obvious scientific rationale for Roche having tested the drug for a year in the first place, she says.

“It was a pragmatic decision,” Stefan Frings, Roche’s head of medical affairs for oncology, said in a telephone interview. The company knew the majority of cancer relapses would occur within the first two years. Testing Herceptin for a year allowed the treatment to cover “a substantial portion of that period,” he said.

Taking the medicine for less time might reduce the risk of heart damage, a potential side effect, according to Earl.

Roche’s two-year trial, dubbed Hera after the wife of Greek god Zeus, is the continuation of one of the studies that established the drug as crucial for patients with a gene mutation that results in extra proteins known as HER2 being pumped out of their cancer cells -- making their tumors susceptible to Herceptin. About one in five breast cancer patients fall into this category.

Not Black, Not White

The other trial due to be presented next week, the French study called PHARE, also has its roots in the 2005 studies that established Herceptin as the gold standard of breast-cancer treatment. After French authorities saw those results, they decided to pay for a year’s treatment for breast cancer patients after surgery, said Xavier Pivot, an oncologist at the University Hospital of Besancon and principal investigator of the trial. At the same time, they decided to fund their own trial to see whether the medicine could be given for less time with the same benefit, Pivot said.

Spurring the French researchers forward was a smaller study in Finland that showed nine weeks of Herceptin -- given with chemotherapy -- resulted in no heart failure side effects, Pivot said. The short course of Herceptin staved off cancer recurrence and death in the trial, published in the New England Journal of Medicine in 2006.

Data from Hera and PHARE will be presented back-to-back at the ESMO conference in Vienna on Oct. 1.

The results probably won’t give “a black and white answer,” Pivot said, adding that the researchers will probably need to look at subsets of patients to see who benefits from six months of treatment and who should get a full year. “More work will probably be needed.”

‘To Be Well’

Countries with tighter budgets may opt to interpret the results differently than richer ones, according to Pivot. Six months of Herceptin might be better than nothing in places where a year’s treatment is considered prohibitive, he said.

There may be similar shades of gray among patients, with some keen to stay on the drug as long as possible to ensure cancer stays away and others, like Butland, wanting their life back.

“The decision is not simply to stop Herceptin,” Butland wrote in a blog posting that spelled out her rationale. “The decision is to be well. The decision is to get on with living in a world that doesn’t have cancer at the heart of it.”

To contact the reporter on this story: Naomi Kresge in Berlin at nkresge@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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