Results from a Phase III clinical trial showed that the enzalutamide prolonged lives of prostate cancer patients and also improved their quality of life.
Findings from the study, conducted by the The Institute of Cancer Research (ICR) and The Royal Marsden NHS Foundation Trust, were presented at the ASCO annual meeting by Professor Johann de Bono from the ICR and The Royal Marsden.
Professor de Bono explained:
"The trial showed that enzalutamide was not only keeping men alive for longer, but for some it was also improving their quality of life. Some patients had been reporting significant pain and so this result is very pleasing.
The success of this trial could give doctors a valuable new treatment option, which is sorely needed as men with advanced prostate cancer have few therapies available to them."
1,199 men with metastatic castration-resistant prostate cancer who had stopped responding to chemotherapy were enrolled to participate in the multinational, randomized placebo-controlled AFFIRM trial.
In order to evaluate quality of life, participants of the trial took a FACT-P assessment that takes into account 27 factors, such as level of pain, energy level, ability to cope with their illness, amount of support needed from family and friends, and ability to work. If a patients score increased by 10% of more, they were defined as having an increased quality of life.
The researchers found that around 43% of men taking enzalutamide said that their quality of life had improved, compared to 18% of those taking placebo. Furthermore, enzalutamide was well tolerated and produced no serious adverse effects.
The team also found that participants taking enzalutamide lived an average of 18.4 months vs. 13.6 months for those taking placebo.
Enzalutamide, the first in a new class of medicines called androgen receptor signaling inhibitors, was designed to attach to the receptors on prostate cancer cells that usually interact with testosterone, and block this interaction, thus preventing prostate cancer growth.
In November 2011, the trial's Independent Data Monitoring Committee recommended that all participants assigned to placebo should be offered enzalutamide.
The pharmaceutical companies Medivation and Astellas, who sponsored the trial, announced that they had submitted a New Drug Application for enzalutamide to the United States Food and Drug Administration on May 21, 2021. In addition, they are also preparing to submit for regulatory approval in Europe and Japan.
Written By Grace Rattue