The European Commission ( EC ) has granted marketing authorisation for Erleada ( Apalutamide ), a next generation oral androgen receptor inhibitor for the treatment of adult patients with non-metastatic castration-resistant prostate cancer ( nmCRPC ) who are at high risk of developing metastatic disease.
The EC approval is based on data from the pivotal phase 3 SPARTAN study, which was published in The New England Journal of Medicine.
The study has assessed the efficacy and safety of Apalutamide plus androgen deprivation therapy ( ADT ) versus placebo plus ADT in patients with nmCRPC who had a rapidly rising prostate specific antigen ( PSA ) level despite receiving continuous ADT.
Findings from the study showed that Apalutamide plus ADT, has significantly reduced the risk of developing distant metastasis or death ( metastasis free survival [ MFS ] ) by 72%, compared to placebo in combination with ADT ( hazard ratio, HR = 0.28; 95% CI, 0.23-0.35; P less than 0.001 ).
The median MFS was improved by over two years ( 40.5 months vs. 16.2 months ) in patients with nmCRPC whose PSA is rapidly rising.
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.
The most common grade 3/4 treatment-emergent adverse events in the SPARTAN study were hypertension ( 14.3% vs. 11.8% ), rash ( 5.2% vs. 0.3% ), fall ( 1.7% vs. 0.8% ) and fracture ( 2.7% vs. 0.8% ).
Treatment discontinuation due to adverse events was 11% in the Apalutamide arm compared to 7% 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 ( 25% vs. 23%, respectively ).
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.
Non-metastatic castration-resistant prostate cancer ( CRPC ) refers to a disease stage when the cancer no longer responds to medical or surgical treatments that lower testosterone, but has not yet been discovered in other parts of the body using a bone scan or CT scan.
Features include: lack of detectable metastatic disease; rapidly rising prostate-specific antigen while on androgen deprivation therapy and serum testosterone level below 50 ng/dL.
Ninety percent of patients with non-metastatic CRPC will eventually develop bone metastases, which can lead to pain, fractures and spinal cord compression.
The relative 5-year survival rate for patients with distant stage castration sensitive or castration resistant prostate cancer is 30%. ( Xagena )
Source: Janssen, 2019