Bayer AG (BAYN)’s experimental cancer drug regorafenib delayed progression of stomach cancer in patients who weren’t benefiting from standard treatments, potentially giving doctors a third weapon to battle gastrointestinal tumors.
Patients who got regorafenib gained an average of about four months longer before their tumors got worse than those who took a placebo, the Leverkusen, Germany-based drugmaker said today at the American Society of Clinical Oncology meeting in Chicago. The Bayer-funded trial, called GRID, didn’t prove that regorafenib helped patients live longer.
Bayer said it plans to ask U.S. and European regulators in the second half of the year to approve regorafenib for the form of stomach tumors called gastrointestinal stromal tumors. If approved, the Bayer treatment could provide another option for the more than 85 percent of patients whose tumor develops a resistance to the only approved drugs on the market, Pfizer Inc. (PFE)’s Sutent and Novartis AG (NOVN)’s Gleevec.
“By inhibiting abnormal signals we’ve increase survival from three-to-six months before 2000 to 5 years or more,” said George Demetri, an associate professor at Harvard University Medical School in Boston, who helped conduct the study. “I’m still taking care of patients who have been on Gleevec for 12 years, but 9 out of 10 aren’t so lucky.”
Bayer has said regorafenib has the potential to generate more than 1 billion euros ($1.2 billion) in annual sales if it’s approved in several different types of cancer. The company agreed last year to pay Onyx Pharmaceuticals Inc. (ONXX), a South San Francisco, California-based biotechnology company, a 20 percent royalty for the use of regorafenib in oncology.
Until recently, Bayer had few cancer drugs in testing compared to its competitors, and only one cancer drug, Nexavar, on the market. That’s starting to change this year after the company decided in 2000 to start heavily investing in cancer research, said Alison Ayers-Ptaszek, head of oncology for Bayer. The German drugmaker has also filed regorafenib for regulatory approval in metastatic colorectal cancer.
“We feel like we have really turned a corner,” said Ayers-Ptaszek. “We aren’t afraid of tackling the difficult things.”
In the study reported today, researchers looked at 199 patients whose tumors had spread or couldn’t be removed, and whose cancer didn’t respond to Sutent or Gleevec.
In those being treated with regorafenib, they had 4.8 months before their tumor progressed compared to 0.9 months among those taking a placebo. The study may not have found an improvement in survival because patients who failed on placebo were allowed to switch over to regorafenib, Demetri said.