GU Cancers 2019 | LATITUDE: Phase III final analysis

I had the pleasure to present the LATITUDE data, or actually Kim, my colleague, who presented them. The final data of the LATITUDE Phase III trial was presented, a program that was conducted in men with de novo metastatic prostate cancer.

These patients were selected as having a very high risk of death, with two out of three high risk criteria. The randomization was between androgen-deprivation therapy plus or minus abiraterone and prednisone. Two years ago we reported the first interim analysis supporting improved overall survival, and also improved radiographic progression for survival favoring the abiraterone arm. Now we have almost two years of additional follow-up and much more men from the control arm receiving a salvage treatment – either abiraterone, enzalutamide or docetaxel or other drugs. We see that the benefit remains. The other ratio is essentially the same with a 34% reduction in the risk of death when abiraterone is being used early in the course of a disease.

So that converts in about an 18-month absolute difference in the median overall survival, which is just significant. Not only does it come together with better progression for survival but also with increased time to pain deterioration, which is very clinically meaningful. There was about 30% reduction in the risk along with many other secondary efficacy endpoints. Regarding safety, we haven’t seen any long-term side effects in these men compared to those we originally reported. In terms of side effects, we are talking about excess in hypertension, hypokalemia, and rarely increased transaminas. However, there were no more side effects than these. So we are very happy because I think we’ve set a new standard of care for these men, and hopefully this will benefit many men on earth.