Johnson & Johnson’s experimental prostate-cancer drug, abiraterone, slowed the disease and extended lives, according to a company-sponsored study.
The trial involved 1,195 patients with advanced prostate cancer that was spreading after treatment with one or two chemotherapy regimens. Patients who received abiraterone, with the steroid prednisone, lived a median of 3.9 months longer than those treated with prednisone alone, the researchers found. The results were presented today at the European Society for Medical Oncology meeting in Milan.
The research is part of the last of the three stages of testing usually needed for regulatory approval. J&J, based in New Brunswick, New Jersey, may file new-drug applications in the U.S. and Europe by the end of the year on the basis of the study results, the company said in a statement today.
“The drug could become a nearly billion dollar opportunity,” Larry Biegelsen, an analyst at Wells Fargo Securities in New York, said in a note to clients on Oct. 7.
Abiraterone, which J&J acquired in its $878 million purchase of Cougar Biotechnology in July 2009, stops tumor cells from making a hormone they need to survive and reproduce.
The National Cancer Institute estimates that 217,730 men in the U.S. will be diagnosed with prostate cancer this year and about 32,000 will die of it. The disease is the second-leading cause of cancer death in American men, after lung cancer, according to the American Cancer Society, based in Atlanta.
J&J decided to reveal which patients in the study were getting abiraterone in August after an interim analysis showed the medicine prolonged survival and had an acceptable safety profile.
Two Months Extra
Tumor progression, as measured by CT and bone scans, was delayed two months longer in those receiving abiraterone, the data showed. Their median survival was 14.8 months, compared with 10.9 months for placebo. Fluid retention, low blood-potassium levels and heart disorders were more common among those taking abiraterone.
Patients in the trial who were assigned to get a sugar pill were offered the J&J treatment. A program to provide early access to other people who meet certain criteria also is expected to begin in the U.S. this month, Ortho Biotech Oncology Research & Development, a division of J&J, said in a statement on Sept. 9.
“The treatment works really well -- it’s exciting,” said Howard Scher, chief of genitourinary oncology at Memorial Sloan-Kettering Cancer Center in New York and the study’s co-lead investigator, in a phone interview today.
The next step is to figure out why some patients respond well to abiraterone while others don’t benefit, Scher said.
Another treatment for prostate cancer, Seattle-based Dendreon Corp.’s Provenge, helped patients live 4.1 months longer than those given a placebo in tests used to gain approval. Comparisons between the two drugs are difficult, because the J&J drug was tested in sicker patients who had failed on at least one chemotherapy, Scher said. In the Provenge study, patients in the placebo group lived 21.7 months.
Provenge, the first drug designed to train the body’s immune system to fight cancer, was cleared for sale by U.S. regulators in April. It costs about $93,000 for three doses administered over the course of a month, while abiraterone may be priced at $27,000 annually, Biegelsen said.
“There is sufficient room for both Provenge and abiraterone to be used in this line of therapy,” Robyn Karnauskas, an analyst in New York for Deutsche Bank Equity Research, wrote in a note to clients today.
J&J rose 6 cents, or less than 1 percent, to $63.29 at 4 p.m. in New York Stock Exchange composite trading. Dendreon rose 52 cents, or 1.3 percent, to $39.75.