Johnson & Johnson said a combination of its cancer drug Erleada and standard hormone therapy helped extend the lives of certain prostate cancer patients in a late-stage clinical trial.
The phase 3 study, named Titan, evaluated the combination of Erleada and androgen deprivation therapy, or ADT, against placebo plus ADT in 1,052 patients with metastatic castration-sensitive prostate cancer.
Metastatic castration-sensitive prostate cancer refers to prostate cancer that has spread to other parts of the body and still responds to ADT — which suppresses or halts the production of male hormones, called androgens, to stop them from affecting prostate cancer cells.
Patients with this type of cancer tend to have a poor prognosis, with a survival time of less than five years, according to a May 31 news release.
The Janssen Pharmaceutical Companies of Johnson & Johnson presented the results of the study in an oral presentation at the 2019 annual meeting of the American Society of Clinical Oncology.
Results from the Titan study showed that Erleada plus ADT extended survival versus the placebo combination with a 33% reduction in the risk of death. The Erleada plus ADT therapy also lowered the risk of radiographic progression or death by 52%.
After a median follow-up of 22.7 months, 82% of the patients on Erleada plus ADT had survived, compared to 74% for placebo plus ADT.
"These data suggest that ADT alone should no longer be considered the standard of care for metastatic castration-sensitive prostate cancer and support Janssen's investigation of Erleada in earlier stages of prostate cancer," said Craig Tendler, vice president of clinical development and global medical affairs for oncology at Janssen Research & Development LLC.
Side effects experienced by patients in the study were generally consistent with the known Erleada safety profile, with the most common adverse events including hypertension and skin rash.
Data from the study formed the basis of an application to the U.S. Food and Drug Administration seeking approval for Erleada to treat patients with metastatic castration-sensitive prostate cancer.
Erleada is approved by the FDA and the European Commission to treat patients with non-metastatic castration-resistant prostate cancer — a type of prostate cancer that has not spread to other parts of the body but continues to grow despite hormone therapy.
The 2019 American Society of Clinical Oncology meeting is expected to bring together more than 32,000 professionals from around the world, with more than 2,400 study abstracts to be presented on site and an additional 3,200 abstracts to be published online.