Prostate cancer drug shows impressive new Phase III trial results
Patients with advanced prostate cancer who were given a new type of hormonal treatment called MDV3100 lived an extra 4.8 months compared to men taking a placebo, according to the full analysis of a Phase III trial jointly led by Professor Johann de Bono.
The multinational, randomised placebo-controlled trial, sponsored by pharmaceutical companies Medivation and Astellas, included 1,999 men with advanced prostate cancer who had all previously received docetaxel-based chemotherapy.
In the final analysis of survival data, men taking MDV3100 lived for a median of 18.4 months compared with 13.6 months for men taking placebo.
The drug also returned positive results on all other measures of effectiveness, known as secondary endpoints. When compared to the placebo group, more patients taking MDV3100 experienced a drop of at least 50 per cent in their prostate specific antigen (PSA) levels (54 per cent versus one per cent), and had more time before their PSA level started to rise (8.3 months versus 3.0 months). X-rays showed mean time until tumour growth among the treatment group was also longer (8.3 months versus 2.9 months).
MDV3100 was also well tolerated by patients, with no serious side-effects.
MDV3100 is the first in a new class of medicines called androgen receptor signaling inhibitors (ARSI). Prostate cancer relies on testosterone to grow, so this drug has been designed to bind to the receptors on prostate cancer cells that normally interact with testosterone, and block this interaction.
