According to a media release from OncoGenex, the U.S. Food & Drug Administration has granted a “fast track” designation to the evaluation of data from the so-called AFFINITY trial of custiren + carbazitaxel + prednisone as a second-line treatment for men with metastatic, castration-resistant prostate cancer (mCRPC). … 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.
According to a new article in Cancer, treatment with enzalutamide for men with metastatic, castration-resistant prostate cancer (mCRPC) after prior treatment with both docetaxel-based chemotherapy and abiraterone acetate demonstrated “modest” clinical activity. … READ MORE …