Johnson & Johnson's Erleada combined with hormone-blocking therapy six months before and after prostate surgery reduced the risk of cancer spread or death by 20% in a late-stage trial with over 2,000 high-risk prostate cancer patients. At surgery, 8.9% of Erleada patients had little to no detectable cancer versus 1% receiving hormone therapy alone. Results were presented at the American Society of Clinical Oncology meeting on May 31, 2026.
Erleada trial results
- ▪Dr. Mary-Ellen Taplin from Dana-Farber Cancer Institute in Boston was the lead researcher of the Erleada trial
- ▪At the time of surgery, 8.9% of patients who received Erleada combination treatment had little to no detectable cancer, compared with 1% of those receiving hormone therapy alone
- ▪A late-stage trial of Johnson & Johnson's prostate cancer drug Erleada followed patients for over five years
- ▪The Erleada trial enrolled more than 2,000 patients with high-risk localized or locally advanced prostate cancer who were candidates for prostate gland removal surgery
- ▪The safety profile of the Erleada combination treatment was consistent with previous studies
- ▪Data from the Erleada trial was presented at the American Society of Clinical Oncology meeting in Chicago on May 31, 2026
- ▪Common side effects among patients who received Erleada treatment include hot flushes, urinary incontinence and erectile dysfunction
Treatment efficacy outcomes
- ▪The addition of Erleada reduced the risk of prostate cancer spreading or death by 20%
- ▪Patients who received Erleada with hormone-blocking therapy were nine times more likely to have little to no detectable cancer in the prostate at the time of surgery compared with those given testosterone-blocking therapy alone
- ▪A full year of treatment with Erleada and hormone therapy reduced the risk of prostate cancer recurrence and death by 29%
- ▪About 40% of the 330,000 people diagnosed with prostate cancer in the U.S. are considered high-risk
Androgen receptor pathway inhibitors
- ▪No androgen receptor pathway inhibitors are approved for localized high-risk prostate cancer with either surgery or radiation as of May 31, 2026
- ▪Erleada, known chemically as apalutamide, belongs to a class of drugs called androgen receptor pathway inhibitors that block signals that drive prostate-cancer growth
- ▪Widely used androgen receptor pathway inhibitors include Pfizer's Xtandi and Bayer's Nubeqa
Prostate cancer surgery timing
- ▪Nearly half of patients who receive the current standard prostate-removal surgery and radiation see their cancer return and require additional treatment
- ▪The Erleada trial also looked at a full year of treatment with Erleada and hormone therapy before and after surgery
- ▪Surgery to remove the prostate and radiation therapy are the standard of care for patients with high-risk localized or locally advanced prostate cancer as of May 31, 2026
Regulatory approval plans
- ▪Johnson & Johnson plans to work with regulators to get the Erleada combination therapy approved globally for earlier stages of prostate cancer
- ▪Erleada won U.S. approval in 2018
- ▪Erleada is currently used in combination with hormone therapy that suppresses production of testosterone, which drives prostate-cancer growth
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