mCRPC in focus
Transcript: PEACE-3
Dr Silke Gillessen
Interview recorded September 2024. All transcripts are created from interview footage and directly reflect the content of the interview at the time. The content is that of the speaker and is not adjusted by Medthority.
The study started 2015, so long time ago. And the question was if the combination of enzalutamide versus the plus radium-223 versus the standard of care enzalutamide would give a benefit in first line mCRPC. And so we had this study, and while the study was already running, the ERA 223 data came out that asked a very similar question, but combined the radium-223 with abiraterone. And what was seen in that study is that there were more fractures. So what we did is doing an urgent safety letter. We like wrote to the investigator that they have to give bone protecting agents to the patients what is actually a standard of care. Like it's an all guidelines, but we saw that only about 50% of the patients had it before we did this amendment to the study. We also excluded osteoporotic patients for the reason that in ERA 223 that study that I mentioned before, the fractures were not only at the site of metastasis, but there were also a lot of osteoporotic fractures. So we amended our study because of this other study.
And what I presented now were the primary outcome. So the primary endpoint was radiological progression-free survival, and that was positive statistically significantly positive, and prolonged in the combination arm with a hazard ratio of .69. And then we looked also at overall survival, and also the overall survival was prolonged with a hazard ratio of .69, with a statistically significant P value in the log-rank test. So because there was a crossing of the curve and because of non-proportional hazards, we decided also together with the IDMC, that we go to the final analysis for overall survival because the log-rank test is not the ideal testing in that setting. But of course, that was quite a nice, let's say, finding that even in overall survival, there was already kind of a very interesting result. Also, statistically, significant prolonged was the time to next treatment. What is an important point for a lot of patients, because in this setting, a lot of the next treatment was chemotherapy, and for patients it's always nice to postpone chemotherapy. So the toxicity was quite, it was quite well-tolerated, the combination, we had a lot of hypertension.
So I think this is something that we learned as well from this study about a bit more than 30% in both arms. So that was most probably an effect of enzalutamide. So it was a kind of a reminder that we have to take very good care of the hypertension in these patients. And then there was also the fractures, as we discussed before, that was higher in the combination arm, anaemia, fatigue, neutropenia, so the classical side effects from radium that we know already since quite some years. So I think, you know, in the end it was, it is kind of a new standard of care option potentially for patients who are in first line mCRPC, and have not received an RP in the hormone sensitive setting. Because we started the trial, as I said in 2015, and we saw that for our patient populations, about 30% had docetaxel, but only very few patients had abiraterone or another RP in that hormone sensitive setting.
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Developed by EPG Health. This content has been developed independently of the sponsor, Pfizer, which has had no editorial input into the content. EPG Health received funding from the sponsor to help provide healthcare professional members with access to the highest quality medical and scientific information, education and associated relevant content. This content is intended for healthcare professionals only.