Johnson & Johnson announce that the European Commission (EC) has licensed prostate cancer treatment Erleada for non-metastatic castration-resistant prostate cancer (nmCRPC)
The licence is based on the results of the phase III SPARTAN trial, which found that the prostate cancer treatment Erleada (apalutamide) in combination with Androgen Deprivation Therapy (ADT) significantly decreased risk of death or distant metastasis by 72 percent, compared to ADT alone. It was also found to improve median metastasis-free survival (MFS) by over three years (40.5 months) compared to just over one year (16.2 months) in the placebo group.
Prostate cancer is the most common cancer diagnosed in males in England, and approximately 84 percent (34,010 people) of those diagnosed suffer from the non-metastatic form of the disease, meaning that the cancer has not spread to other parts of the body (for example, the bones). If the disease is castration-resistant, it no longer responds to medical or surgical treatments that lower testosterone. 90 percent of patients with nmCRPC will eventually develop bone metastases, which is a turning point in prostate cancer, as it is a key cause of complications and death. Extending the period without metastases is therefore an important treatment goal.
Apalutamide is a next-generation oral androgen receptor (AR) inhibitor that blocks the androgen signaling pathway in prostate cancer cells. Apalutamide inhibits the growth of cancer cells in three ways: by preventing the binding of androgen to the AR; by stopping the AR from entering the cancer cells; and by preventing the AR from binding to the DNA of the cancer cell.
In December 2018 NICE approved a Non-invasive MRI diagnostic method for prostate cancer. While in June of 2018 Astellas announced enzalutamide trial results for men with prostate cancer.
The most common Grade 3/4 treatment-emergent adverse events in the SPARTAN study were hypertension, rash, fall and fracture. Treatment discontinuation due to adverse events was 10.6 percent in the apalutamide arm compared to 7 percent in the placebo arm. Rates of serious adverse events were similar in the apalutamide in combination with ADT arm versus placebo in combination with ADT arm.
Commenting on the EC licence of the prostate cancer treatment Erleada, Dr Simon Chowdhury, Consultant Medical Oncologist, Guy’s and St Thomas’ Hospitals, said: “Apalutamide is one of the first treatments shown to be effective in this group of patients, as phase 3 clinical data demonstrated that it significantly prolonged the time that patients with non-metastatic castration-resistant prostate cancer survived without their cancer becoming metastatic (spreading to other sites in their bodies).”
Mohamed Lockhat, Therapeutic Area Medical Affairs Director for Oncology at Janssen UK said, “We are pleased that the EC has authorised apalutamide for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer. At Janssen, we remain committed to our goal of developing and delivering innovative medicines that transform patients’ lives, and today’s approval brings us one step closer to achieving this.”