The use of a drug from Johnson & Johnson resulted in a lower spread of prostate cancer and reduced deaths, according to a study published on May 31.
The drug Erleada—combined with therapy reducing hormone levels—led to significant improvement in both short- and long-term outcomes in prostate cancer patients, the researchers said in a paper published by the New England Journal of Medicine.
Patients who received Erleada, also known as apalutamide, were nine times more likely to have little to no cancer remaining after a median follow-up of 61.7 months, compared to people who only undertook the therapy.
The incidence of cancer spread or death was also 20 percent lower in the treatment group.
“Reducing the risk of prostate cancer recurrence and death with improved initial treatment regimens has been a longstanding unmet need for patients with localized high-risk prostate cancer,” Dr. Mary-Ellen Taplin, an oncologist at the Dana Garber Cancer Institute, and the principal investigator of the trial, said in a statement. She said the drug plus therapy approach “is already standard in other aggressive cancers and now has proven benefit in patients with this disease.”
Dr. Yusri Elsayed, Johnson & Johnson’s global therapeutic area head, added: “These findings point to a new potential way of treating patients with high-risk localized or locally advanced prostate cancer. Apalutamide has already shown an overall survival benefit in advanced disease. Now we’re seeing its impact when used earlier, alongside surgery.”
The trial involved 2,109 patients, about half of whom received the drug and therapy. The other arm received the therapy and no drug.
It also showed additional benefits, including less risk of disease recurrence, the researchers said.
The trial was funded by Johnson & Johnson.
Erleada is currently approved for treating certain kinds of prostate cancer, but not for people with high-risk prostate cancer.
About 330,000 people are diagnosed with prostate cancer in the United States each year, and up to four in 10 of those are classified as high-risk.
Side effects on Food and Drug Administration labeling for the drug include seizures and lung disease.
The most common health problems after use in the trial included hot flush, urinary incontinence, and erectile dysfunction. Adverse events potentially linked to the drug were about the same between arms, although there were more skin rash reports in drug recipients than the others.
More participants in the treatment arm, 7.4 percent, dropped out of the study, compared to 2.7 percent of the group that did not receive the drug.