Reuters-reported late-stage trial: Erleada (apalutamide) added to testosterone-blocking hormone therapy for six months before and after prostatectomy improved tumor clearance at surgery and cut the risk of progression or death by 20%. The study followed patients for more than five years and found a ninefold increase in the likelihood of minimal or no detectable cancer at surgery. A separate year-long regimen extended the average time to additional therapy to over six years and lowered recurrence and death risk by 29%. Results were presented at ASCO in Chicago and may influence care for men with high-risk localized or locally advanced prostate cancer.
ASCO: Erleada (Apalutamide) With Hormone Therapy Cuts Risk Of Progression Or Death By 20%
Johnson & Johnson’s Erleada Cuts Risk of Cancer Spread or Death by 20%, Reuters Reports
Reuters reported on May 31 that a late-stage clinical trial found Johnson & Johnson’s prostate cancer drug Erleada (apalutamide), when given alongside testosterone-blocking hormone therapy for six months before and six months after prostate removal surgery, improved the chances of clearing detectable tumor at surgery and reduced the risk of disease progression or death.
Key Findings
The multi-year trial followed patients for more than five years. Investigators reported that patients who received the Erleada-plus-hormone blockade regimen were nine times more likely to have little or no detectable cancer in the prostate at the time of surgery compared with those who received hormone therapy alone. Johnson & Johnson said the addition of Erleada reduced the risk of metastasis or death by 20%.
The results were presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago and could influence treatment decisions for men with high-risk localized or locally advanced prostate cancer. Current standard care for these patients typically includes prostatectomy (surgery to remove the prostate) or radiation therapy.
Extended Treatment Arm
The trial also included an arm in which patients received a full year of apalutamide plus hormone therapy before and after surgery. Men in this year-long regimen went, on average, more than six years before requiring additional therapy—nearly twice as long as those who received hormone therapy alone. Johnson & Johnson reported that the extended regimen reduced the risk of recurrence and death by 29%.
Context And Next Steps
Johnson & Johnson notes that roughly 40% of the approximately 330,000 people diagnosed with prostate cancer each year in the United States are classified as high-risk. While these results are encouraging, clinicians will weigh the full ASCO presentation and subsequent peer-reviewed publications to evaluate safety, subgroup effects, and long-term outcomes before changing practice guidelines. Additional data on adverse events, quality of life, and cost-effectiveness will be important for adoption.
About Johnson & Johnson: Johnson & Johnson (NYSE: JNJ) and its subsidiaries research, develop, manufacture, and sell healthcare products through its Innovative Medicine and MedTech segments.
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