The European Commission has approved the use of Erleada (apalutamide) for the treatment of men with castration-resistant prostate cancer at high risk of developing metastasis, announced Janssen Oncology, the therapy’s developer.
The decision follows promising data from a Phase 3 trial (NCT01946204), called SPARTAN, where Erleada treatment reduced the risk of cancer spreading by 72% without affecting quality of life scores. In the U.S., the medicine was approved for a similar indication in February 2018.
“Today’s approval of apalutamide is a significant milestone and we are pleased that we can now offer patients with high-risk non-metastatic castration-resistant prostate cancer a new treatment option,” Ivo Winiger-Candolfi, MD, oncology solid tumor therapy area lead for Europe, the Middle East, and Africa at Janssen affiliate Cilag GmbH International, said in a press release.
“Bringing medicines to patients at earlier stages of disease is vital, and the approval of apalutamide could mark a step change in how we treat prostate cancer in the future. Crucially, treating patients at this stage could delay the cancer from spreading, a key part of our commitment to patients living with this disease and to their families,” he added.
Metastasis is a major cause of complications and death among men with prostate cancer, and investigators have been focusing on the prevention of metastasis in men at risk, which may significantly extend their lives and improve their quality of life.
Erleada is an oral agent that prevents the binding of testosterone to the androgen receptor, blocking signals that prostate cancer cells require to grow and proliferate.
SPARTAN included 1,207 patients with non-metastatic, castration-resistant prostate cancer whose prostate-specific antigen (PSA) levels were rapidly rising while receiving androgen deprivation therapy. During the trial, all participants continued to receive hormone therapy and were randomly either assigned oral Erleada or a placebo once daily.
Erleada treatment extended the time patients lived without the disease spreading by more than two years — 40.5 months versus 16.2 months — representing a 72% reduction in the risk of disease spread or death.
This benefit was seen across different subgroups, including in patients with high rates of disease progression and in those with cancer cells in their lymph nodes. Erleada improved the outcomes across all age groups, but younger patients — those younger than 65 years — benefited the most from the treatment, showing an 86% reduction in the risk of metastasis or death.
Erleada also extended the time patients lived without disease progression — 40.5 months versus 14.7 months — and lowered the risk for symptomatic progression by 55%.
While patients receiving hormone treatment plus a placebo showed a trend toward a worse quality of life, those on Erleada plus hormone treatment maintained their quality of life scores throughout the study.
In general, Erleada was well-tolerated, with patients experiencing similar rates of serious adverse events as those on the placebo. The most common serious or life-threatening side effects were high blood pressure, rash, falls, and fractures.
“One of the key goals in prostate cancer treatment is to delay the disease from spreading. Once the cancer spreads, it can become less responsive to treatment, impacting patients’ quality of life and ultimately worsening their prognosis. Median survival for these patients is approximately three years,” said Simon Chowdhury, consultant medical oncologist at the Guy’s and St Thomas’ Hospitals in London.
“It is crucial that we delay the development of metastases for as long as possible. Therefore, the approval of apalutamide, a treatment which can significantly increase time without metastases, is a major step-forward for patients with prostate cancer,” he added.