Some biostatisticians may scoff, but Antigenics is not giving up on its treatment to stimulate the immune system to fight cancer. The Lexington, MA-based biotech company (NASDAQ: AGEN) has found that nine years after its most important clinical trial began, its experimental drug appears to be helping certain kidney cancer patients live longer.
The data are still preliminary, but Antigenics has found that kidney cancer patients with an intermediate risk of relapse after they had tumors surgically removed had a 46 percent lower risk of dying if they also got the company’s vitespen (Oncophage) treatment, compared with those who didn’t. The finding comes from analyzing records of 362 patients out of 604 who enrolled in an Antigenics clinical trial from 2000 to 2005, according to research being presented today at the American Society of Clinical Oncology.
This finding, while provocative, is sure to spark debate about whether it is legit. The original study wasn’t designed to show a survival advantage for Oncophage, and the trial actually failed on its main goal—to reduce the risk of cancer relapse after tumors were surgically removed. But Antigenics has persisted over the past three years, because after further digging through the data, it found that the drug could keep patients in remission longer—as long as they were among the 60 percent of patients who have an intermediate risk of recurrence. That data was strong enough for the company to win approval to market the product in Russia, and Antigenics has applied for approval on that basis in the European Union. The company’s hope is that since the survival analysis will buttress its argument that Oncophage’s effect is real, the drug deserves a shot in the marketplace.
A strict reading of biostatistics says this whole exercise, at worst, is a “fishing expedition,” because it looks backward in time, and at best, it might be interesting fodder for generating a new hypothesis for a clinical trial. But Antigenics says it’s not practical to spend the many years and millions of dollars it would take to test this hypothesis in a new trial—especially when you’re talking about the gold standard measurement for cancer drugs—survival time.
“You can not cheat on survival,” says Garo Armen, Antigenics’ CEO. “The person is either alive or dead. It’s black or white.”
If Antigenics can ever get this drug approved by the FDA, it has potential to reach a large group of patients. About 54,000 new cases of kidney cancer were diagnosed in the U.S. last year, and 13,000 died from the disease.
At least one prominent statistician, Richard Simon of the National Cancer Institute, has looked at the data and told the company he considers it a valid exercise, Armen says. The principal investigator of the trial, Christopher Wood of M.D. Anderson Cancer Center in Houston, TX, said in a company statement, “these interim results show that Oncophage has a real promise of improving survival in patients with earlier-stage disease for whom current prognosis remains poor.”
Still, Armen stopped short … Next Page »