Astellas Pharma Europe has reported that the investigational drug MDV3100 extended life by nearly five months compared to a placebo in a Phase III trial in men with advanced prostate cancer, previously treated with chemotherapy.
Developed by Astellas Pharma and Medivation, MDV3100 is a novel, oral androgen-receptor signalling inhibitor in clinical development for advanced prostate cancer.
MDV3100 acts by blocking testosterone binding to the androgen receptor, impairing movement of the androgen receptor to the nucleus of prostate cancer cells and inhibiting binding to DNA.
The randomised double-blind placebo-controlled multinational Phase III AFFIRM trial investigated MDV3100 160 mg/day in 1,199 men with advanced prostate cancer who were previously treated with docetaxel-based chemotherapy.
The data from the AFFIRM study showed that MDV3100 demonstrated a considerable improvement in overall survival with a median improvement over placebo of 4.8 months.
The primary endpoint of the trial was overall survival, while the secondary objectives included radiographic progression-free survival (rPFS) and time to prostate-specific antigen (PSA) progression and time to first skeletal-related event (SRE).
In the MDV3100 group, the median rPFS was found to be 8.3 months compared to 2.9 months for placebo.
The study also confirmed that MDV3100 was well tolerated and met all secondary endpoints in men with prostate cancer.
Rheinisch-Westfälische Technische Hochschule (RWTH) University, Aachen, Germany, Department of Urology chairman and director, Axel Heidenreich, said: "Extending patients’ lives at this late stage of their disease is the university’s primary aim, but it’s incredibly important to balance this with the impact treatment may have on patient quality of life."
Heidenreich added: "These data are encouraging and indicate that as well as extending the time until their disease progresses and providing a significant survival benefit, this is achieved without significant impact on the patient due to side effects."
The research conducted by APEL across five European countries also revealed that extended overall survival is thought to be the important attribute of a new advanced prostate cancer treatment.
Image: Micrograph of prostate adenocarcinoma, acinar type, the most common type of prostate cancer. Photo: Nephron.