Enzalutamide is established in the castration resistant setting – it improved survival in the AFFIRM study post-docetaxel; it improved survival in the PREVAIL study pre-chemotherapy; it delayed metastasis or death in non-metastatic castration resistant disease. Our STREAM study actually is a phase II study moving enzalutamide even earlier to the non-metastatic hormone sensitive setting. So this is an attempt to move enzalutamide into a setting where men are getting salvage radiation with curative intent. These are patients who have had prostatectomy, their PSAs are going up and the standard of care for them has been just radiation to the prostate bed. Many of these men will still suffer further relapses because of microscopic metastatic disease and we know that AR inhibition can be radiosensitising, that’s the basis for the better outcomes with radiation and hormone therapy over radiation alone.
We presented today the STREAM trial which is a phase II multicentre study. Nearly 40 men treated over six months with enzalutamide, ADT, salvage radiation; very well tolerated. We showed that 65% of men are free of disease and off therapy three years later. So it’s very exciting data; the two and three year outcomes are superior to what we would expect with historic data suggesting that enzalutamide actually might be more effective to improve the remission rate and long-term remission rate for these patients. It would justify larger phase III controlled studies with much longer follow-up but this serves as one of the first studies to report enzalutamide with radiation.