The European Commission (EC) has agreed to extend the use of Janssen’s Erleada (apalutamide) to treat men whose metastatic prostate cancer still responds to androgen deprivation therapy (ADT), a condition known as metastatic hormone-sensitive prostate cancer (mHSPC).
The decision, which follows a positive recommendation issued earlier this month by a committee of the European Medicines Agency, is for a combination of Erleada and ADT. This combination was approved by the U.S. Food and Drug Administration for a similar indication in September.
Findings from the double-blind TITAN Phase 3 trial (NCT02489318) — which supported both approvals — showed that the Erleada-ADT combination was significantly better than ADT alone at extending survival and delaying disease worsening in mHSPC patients.
“Prostate cancer is the most prevalent form of cancer in men throughout Europe, and the expanded approval of apalutamide marks a significant advancement for those living with mHSPC,” Axel S. Merseburger, MD, a chair of the urology department at University Hospital Schleswig-Holstein, in Kiel, Germany, said in a press release.
“In prostate cancer treatment, our primary goal is always to delay progression of disease and prolong survival … Today’s news is therefore an encouraging development for patients within Europe, for whom the importance of an additional treatment option that can both delay progression and extend survival cannot be underestimated,” he added.
mHSPC, also known as metastatic castration-sensitive prostate cancer (mCSPC), refers to prostate cancer that has spread to other parts of the body but still responds to ADT, or conventional hormone therapy. Men with this type of prostate cancer tend to have poor outcomes, with a median overall survival of less than five years.
Erleada is also a hormone therapy — it inhibits the activation of the androgen receptor by androgens, like testosterone — but it works through a different mechanism than ADT, which lowers androgen levels in the body. This has led researchers to believe that a combination of Erleada and ADT could more effectively block androgen signaling, and be better at extending survival outcomes.
Participants had a broad range of clinical features, including both low- and high-volume disease, newly diagnosed cancer, and those with previous treatment for localized or metastatic prostate cancer.
They were randomly assigned to either tablets of Erleada (total of 240 mg) or a placebo once daily, plus continuous ADT — in the form of a gonadotropin-releasing hormone analog or surgical castration — until disease progression or unacceptable toxicity related to treatment.
TITAN’s main goal was to determine if adding Erleada significantly extended the time to disease worsening (as assessed by radiography) or death, and overall survival in men with mHSPC. Both these objectives were met: Erleada led to a 33% reduction in the risk of death compared to placebo, and a 52% reduction in the risk of disease progression or death.
Two years after the start of treatment, 82% of patients on Erleada were still alive versus 74% of those on placebo. Similarly, the percentages of patients progression-free at two years were 68% for Erleada and 48% for placebo.
The frequency of severe to life-threatening adverse events was similar between the two groups — 42% for Erleada and 41% for placebo. Adverse events led to deaths in 1.9% of patients on Erleada and in 3.0% of those on placebo, and led to 8.0% and 5.3% of patients in each group discontinuing treatment.
“We are delighted with the EC’s approval of the extended use of apalutamide, which makes an important treatment option potentially available to over 100,000 patients living with mHSPC across Europe,” said Joaquín Casariego, MD, area lead for oncology in Europe, Middle East and Africa at Janssen.
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