Johnson & Johnson said its prostate cancer drug Erleada, when used with hormone-blocking therapy before and after prostate surgery, improved the chances of eliminating cancer and reduced the risk of disease progression or death in a late-stage trial.
The findings were presented at the American Society of Clinical Oncology meeting in Chicago and came from a late-stage trial of more than 2,000 men with high-risk localized or locally advanced prostate cancer who were followed for more than five years.
Patients who received Erleada with hormone-blocking therapy six months before and six months after surgery were nine times more likely to have little to no detectable cancer in the prostate at the time of surgery compared with patients who received testosterone-blocking therapy alone.
At the time of surgery, 8.9% of patients who received the combination treatment had little to no detectable cancer, compared with 1% of those who received hormone therapy alone.
Johnson & Johnson also said the addition of Erleada reduced the risk of cancer spreading or death by 20%.
The findings are likely to change how doctors treat men with high-risk localized or locally advanced prostate cancer. Surgery to remove the prostate and radiation therapy are currently the standard treatments for these patients.
Johnson & Johnson said about 40% of the 330,000 people diagnosed with prostate cancer in the United States are considered high-risk.
The study also examined a full year of treatment with Erleada and hormone therapy before and after surgery. In that group, patients who received the combination therapy went, on average, more than six years before needing additional treatment. That was nearly double the time seen in the hormone therapy alone group.
The longer treatment with Erleada also reduced the risk of recurrence and death by 29%.
Johnson & Johnson said nearly half of patients who receive the current standard treatment of prostate-removal surgery and radiation have their cancer return and require additional treatment.
Erleada, known chemically as apalutamide, belongs to a class of drugs called androgen receptor pathway inhibitors. These medicines block signals that help drive prostate cancer growth.
Johnson & Johnson said the safety profile of the Erleada combination treatment was consistent with previous studies. Common side effects among patients who received the treatment included hot flashes, urinary incontinence and erectile dysfunction.
Erleada received U.S. approval in 2018. It is currently used in combination with hormone therapy that suppresses testosterone production, which drives prostate cancer growth.
Johnson & Johnson said it plans to work with regulators to seek global approval for the combination therapy in earlier stages of prostate cancer.
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