Yeah, so this is a great question, which is basically, what are we going to do in the clinic on Wednesday? And I think to answer that question, we have to put this into context with the STAMPEDE findings. So everyone knows that STAMPEDE showed a benefit to the addition of abiraterone for those patients who qualified for their trial, who met the Stampede very high-risk criteria...
Yeah, so this is a great question, which is basically, what are we going to do in the clinic on Wednesday? And I think to answer that question, we have to put this into context with the STAMPEDE findings. So everyone knows that STAMPEDE showed a benefit to the addition of abiraterone for those patients who qualified for their trial, who met the Stampede very high-risk criteria. And I think that our results really complement the STAMPEDE results. So if you look at our results for the clinically node-positive patients, the hazard ratio is basically almost exactly the same as Stampede’s. So our hazard ratio for enzalutamide for clinical node-positive was 0.43. The Stampede hazard ratio for clinical node-positive was 0.49. So very similar. But we didn’t show a benefit really for the other patients. So what’s the difference? Well, I think the difference is that overall we enrolled lower-risk patients than the STAMPEDE population did. So if you look at Stampede, they had 39% node positive. We had 11% node positive. Stampede had a median PSA of 35. We had a median PSA of 14. Stampede had 92% with clinical T3, T4. We had 47% with clinical T3, T4. So this is just a different, it’s a lower-risk group of patients. They’re all high-risk, but a different risk group. Now, we did an exploratory analysis that looked at by the Stampede eligibility. And we found that, okay, if you were clinically node-positive, then as we said, there was a benefit hazard ratio 0.43. But if you were in the Enzalutamide trial, clinically node-negative, but you would have qualified for Stampede, there really wasn’t a strong effect. The hazard ratio was 0.85, very similar to the overall hazard ratio for the trial of 0.88. And it crossed one. And then if you were clinically node-negative and didn’t qualify for STAMPEDE, there was no benefit. So how do I put this into practice? What am I going to do in clinic on Wednesday? What I think is obviously for clinical node-positive, we should be adding an androgen receptor pathway inhibitor, such as abiraterone or enzalutamide, in addition to radiation and hormones, often referred to as RP for short, but in this context likely referring to the combination of treatments. I think for those patients who meet the Stampede, very high-risk criteria, but who also look like the patients who are enrolled on the Stampede trial, I think you should add an androgen receptor pathway inhibitor. But remember, these patients, these had a median PSA of 35. Those patients, go ahead. But I don’t think that all the patients that met the STAMPEDE criteria necessarily have to get an androgen receptor pathway inhibitor, because we had plenty of patients who met STAMPEDE who didn’t benefit from the androgen receptor pathway inhibitor. So I think if you look more like an Enzalutamide patient, if your median PSA was 14, then even if you meet Stampede criteria, I think it’s not clear that you really need something. And then obviously for those who don’t meet Stampede criteria, radiation and two years of hormones are the way to go.
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