Updated Erleada Data Shows Reduced Risk of Death in Prostate Cancer Patients

Treatment with Erleada plus androgen deprivation therapy resulted in a 25% reduction in the risk of death compared to placebo in prostate cancer patients, Janssen announced at the 2019 European Society for Medical Oncology (ESMO) Congress today.

Janssen, a division of Johnson & Johnson, provided updated, long-term results from its Phase III SPARTAN study, the study which initially won Erleada approval from the U.S. Food and Drug Administration in 2018 for non-metastatic castration-resistant prostate cancer (NM-CRPC) who were at high risk of developing metastases. The latest data showed overall survival results supported previous data, despite a crossover of patients receiving placebo to the Erleada treatment group, Janssen said.

Margaret Yu, prostate cancer disease area leader at Janssen Research & Development, noted that despite the advances in treating prostate cancer, it’s still a lethal illness, particularly when patients’ disease becomes metastatic.

Prostate cancer is the second most common cancer in men worldwide. Castration-resistant prostate cancer refers to the subset of men whose prostate cancer progresses despite castration levels of testosterone. Non-metastatic castration-resistant prostate cancer refers to a disease state when the cancer no longer responds to medical or surgical treatments that lower testosterone but has not yet been discovered in other parts of the body. Ninety percent of patients with CRPC will eventually develop bone metastases, which can lead to pain, fractures and spinal cord compression. The relative 5-year survival rate for patients with distant stage prostate cancer is 30 percent.

Erleada works by blocking the effect of androgens, a type of hormone, on the tumor. These androgens, such as testosterone, can promote tumor growth.

At the second interim analysis, a longer median follow-up of 41 months, four-year overall survival (OS) rates were 72.1% for patients treated with Erleada and 64.7% for patients treated with placebo, the company said. Overall, a 25% reduction in the risk of death was observed for patients receiving Erleada compared with placebo. The OS benefit of Erleada was consistent across baseline subgroups, such as race, prior treatments, baseline PSA and performance status, the company noted. This interim analysis took place when 67% of the required OS events had been observed, compared with the original report when only 24% of required OS events had occurred. After unblinding the study and prior to the second interim analysis, 76 non-progressing patients in the placebo group, 19%, crossed over to open-label Erleada. The OS data includes patients who crossed over. The new data from the SPARTAN trial was published in the Annals of Oncology, as well as presented at ESMO.

Matthew Smith, director of the Genitourinary Malignancies Program at the Massachusetts General Hospital Cancer Center and co-principal investigator of the SPARTAN study, said the updated SPARTAN analysis shows an important survival benefit for Erleada.

“Longer-term analyses help to present a more complete picture of a medication's benefits and potential risks over time. These results add to the evidence supporting apalutamide (Erleada) as a standard option for treating patients with non-metastatic castration-resistant prostate cancer who remain at high risk of their cancer spreading,” Smith said in a statement.