J&J’s Erleada improves outcomes for high-risk prostate cancer patients, study finds
Synopsis
New late-stage trial data showed Johnson & Johnson's Erleada considerably improved outcomes for patients with high-risk prostate cancer when used before and after surgery.
Johnson & Johnson said new late-stage trial data showed its prostate cancer drug Erleada considerably improved outcomes for patients with high-risk localised or locally advanced prostate cancer when used alongside hormone-blocking therapy before and after surgery. The findings suggest the treatment could reshape how doctors manage patients with aggressive forms of prostate cancer.
Key highlights
- Erleada combined with hormone therapy improved prostate cancer outcomes in a late-stage study
- Patients were nine times more likely to have little or no detectable cancer at surgery
- The treatment reduced the risk of cancer spread or death by 20%
- A longer treatment regimen reduced recurrence and death risk by 29%
- Results were presented at the American Society of Clinical Oncology meeting
What happened?
Johnson & Johnson presented results from a late-stage clinical trial at the American Society of Clinical Oncology (ASCO) meeting in Chicago.
The study evaluated Erleada, also known as apalutamide, in combination with hormone-blocking therapy before and after prostate removal surgery.
Researchers followed patients for more than five years and found that those receiving the Erleada regimen were nine times more likely to have little or no detectable cancer in the prostate at the time of surgery compared with patients receiving hormone therapy alone.
The combination treatment also reduced the risk of cancer spreading or death by 20%.
Why this matters
High-risk localised and locally advanced prostate cancer patients face a major risk of recurrence even after surgery and radiation treatment.
According to Johnson & Johnson, nearly half of patients receiving current standard treatment eventually see their cancer return and require additional therapy.
The new findings suggest that adding Erleada before and after surgery could improve long-term outcomes and delay disease progression.
The company said around 40% of the approximately 330,000 people diagnosed with prostate cancer annually in the United States are considered high-risk.
Longer treatment showed additional benefits
The study also evaluated a treatment regimen involving a full year of Erleada combined with hormone therapy before and after surgery.
Patients receiving the extended treatment remained free from additional therapy for more than six years on average.
That was nearly double the duration observed in patients treated with hormone therapy alone.
The longer Erleada regimen also reduced the risk of cancer recurrence and death by 29%.
Official statements
Dr. Mary-Ellen Taplin of the Dana-Farber Cancer Institute, who led the study, said the results could majorly influence future treatment approaches.
"No ARPIs are approved for localised high-risk prostate cancer with either surgery or radiation. So the data would be paradigm changing."
Mark Wildgust, Johnson & Johnson's medical affairs lead for oncology, said the trial demonstrated a clear benefit for patients.
"The patient benefit here is unequivocal."
He added: "I think that the evidence is really showing that Erleada is adding something that we had not seen before."
Background & Context
Erleada belongs to a class of medicines known as androgen receptor pathway inhibitors (ARPIs).
These drugs block signals that help drive prostate cancer growth.
Other widely used ARPIs include Pfizer's Xtandi and Bayer's Nubeqa.
The trial enrolled more than 2,000 patients with high-risk localised or locally advanced prostate cancer who were eligible for prostate-removal surgery.
At the time of surgery, 8.9% of patients receiving Erleada plus hormone therapy had little or no detectable cancer, compared with 1% of patients receiving hormone therapy alone.
Johnson & Johnson said the treatment's safety profile was consistent with previous studies.
Common side effects included:
- Hot flushes
- Urinary incontinence
- Erectile dysfunction
What happens next?
Johnson & Johnson said it plans to work with regulators to seek approvals for the combination treatment in earlier stages of prostate cancer.
If approved, the therapy could become a new treatment option for patients with high-risk localised and locally advanced prostate cancer undergoing surgery.
The findings are also expected to influence future clinical discussions around prostate cancer treatment strategies.
FAQs
Q1: What is Erleada?
Erleada, also known as apalutamide, is a prostate cancer medicine that blocks androgen receptor signals that help cancer cells grow.
Q2: What did the study find?
The study found that Erleada combined with hormone therapy improved cancer outcomes and reduced the risk of cancer spread or death in high-risk prostate cancer patients.
Q3: How much did the treatment reduce the risk of disease progression or death?
The combination therapy reduced the risk of cancer spreading or death by 20%.
Q4: How many patients took part in the trial?
More than 2,000 patients with high-risk localised or locally advanced prostate cancer participated in the study.
Q5: Is Erleada already approved?
Yes. Erleada received US approval in 2018 and is currently used with hormone therapy for certain prostate cancer patients. Johnson & Johnson plans to seek approvals for use in earlier-stage disease settings.
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