According to a media release today from Bayer HealthCare and Orion Corporation (a Finnish pharmaceutical company), they have started to enroll patients in a randomized Phase III clinical trial of ODM-201, a novel, oral androgen receptor inhibitor in development for the treatment of men with advanced forms of prostate cancer. … READ MORE …
A paper in Clinical Cancer Research has reported an overall survival (OS) benefit of the investigational drug tasquinimod compared to a placebo in men with castration-resistant prostate cancer after treatment with docetaxel-based chemotherapy.
These data come from the long-term follow-up of the randomized Phase II trial of tasquinimod, and we shall have to wait for the results of the ongoing Phase III trial to confirm these results, but, according to this paper by Armstrong et al.:
- Patients taking tasquinimod had a median OS of 33.4 months compared to 30.4 months for men treated with a placebo.
- Patients whose cancer had already metastasized to their bones survived an average of 34.2 months, compared to 27.1 months for men treated with a placebo.
Additional information about this study can be found in a media release from the Duke University Health System; in an article on the OncLive web site; and in the actual paper by Armstrong et al.
It is worth remembering that few of the patients originally enrolled in this Phase II trial would have received either abiraterone acetate or enzalutamide prior to their initial treatment with either tasquinimod or the placebo, and that some of these patients may well have received abiraterone acetate or enzalutamide (or both) after their treatment with tasquinimod. It may be difficult, as a consequence, to know how much of the survival benefit shown in this trial is a direct consequence of treatment with tasquinimod itself. This is one of the reasons that the outcome of the later Phase III trial will be very important.
There was an intriguing paper in the November 2013 issue of the journal Prostate suggesting that intermittent dosing with testosterone in between doses of androgen deprivation therapies may actually help men in the early stages of castration resistance to respond better to treatment over time. … READ MORE …