Johnson & Johnson reported results from a late-stage study indicating that Erleada (apalutamide), when added to conventional hormone-blocking therapy and given for six months before and six months after radical prostatectomy, significantly raised the odds of having little to no detectable cancer at the time of surgery and reduced the risk that the disease would progress or lead to death.
The trial, presented at the American Society of Clinical Oncology meeting in Chicago, followed participants for more than five years. Investigators found that patients receiving the Erleada-plus-hormone regimen were nine times more likely to have minimal or undetectable tumor remaining in the prostate at surgery than patients treated with testosterone-suppressing therapy alone.
Johnson & Johnson reported that adding Erleada to standard hormone therapy cut the combined risk of metastasis or death by 20% in the regimen that spanned six months pre-surgery and six months post-surgery.
The study also evaluated an extended course in which Erleada and hormone suppression were administered for a full year before and a full year after surgery. For patients treated with that longer schedule, the time until requiring subsequent therapy extended to more than six years on average - nearly double the time observed in the group that received hormone therapy alone. The year-long treatment additionally reduced the risk of recurrence and death by 29%, according to the company.
About 40% of the roughly 330,000 people diagnosed with prostate cancer in the United States each year are classified as high-risk, Johnson & Johnson said. Current practice for men with high-risk localized or locally advanced disease typically centers on surgery to remove the prostate and radiation therapy, with many patients later experiencing return of disease and need for additional treatment.
More than 2,000 patients with high-risk localized or locally advanced prostate cancer who were eligible for prostate gland removal were enrolled in the trial. At the time of surgery, 8.9% of those assigned the combination of Erleada plus hormone therapy had little to no detectable cancer remaining in the prostate, compared with 1% of patients who received hormone suppression alone.
"No ARPIs are approved for localized high-risk prostate cancer with either surgery or radiation. So the (data) would be paradigm changing," said Dr. Mary-Ellen Taplin of Dana-Farber Cancer Institute, the study's lead researcher.
Erleada is part of the androgen receptor pathway inhibitor (ARPI) class, agents that block signaling pathways which fuel prostate-cancer growth. Widely used drugs in the same class cited by the company include Pfizer’s Xtandi and Bayer’s Nubeqa.
"The patient benefit here is unequivocal," said Mark Wildgust, Johnson & Johnson’s medical affairs lead for oncology. "I think that the evidence is really showing that Erleada is adding something that we had not seen before."
Johnson & Johnson reported that the safety profile observed with the combination treatment aligned with previous studies of the drug. The company listed common adverse effects among treated patients as hot flushes, urinary incontinence and erectile dysfunction.
Erleada received U.S. approval in 2018 and is already employed in combination with androgen-deprivation therapy, which suppresses testosterone production - a driver of many prostate cancers. Following the trial findings, the company said it plans to engage with regulatory authorities to seek approval for use of the Erleada-plus-hormone combination in earlier stages of prostate cancer globally.
These results may prompt reconsideration of treatment strategies for men with high-risk localized or locally advanced prostate cancer, contingent on regulatory review and subsequent adoption by clinicians. The magnitude of tumor eradication at surgery and the extension in time to subsequent therapy reported in this trial are central outcomes that will inform those discussions.