It was a perioperative trial on muscle invasive bladder carcinoma, exploring the combination of gemcitabine cisplatin in the combination of pembrolizumab versus placebo in cisplantin-eligible patients. So we had the neoadjuvant part, we had the cystectomy and then we had the adjuvant parts, so forming really a perioperative setting...
It was a perioperative trial on muscle invasive bladder carcinoma, exploring the combination of gemcitabine cisplatin in the combination of pembrolizumab versus placebo in cisplantin-eligible patients. So we had the neoadjuvant part, we had the cystectomy and then we had the adjuvant parts, so forming really a perioperative setting. So KEYNOTE-866 is the first phase 3 trial which was placebo-controlled using gemcitabine plus immunotherapy versus placebo in that setting. The primary endpoint of that trial was event-free survival and key secondary endpoints included overall survival and pathological complete response rate. So unfortunately the primary endpoint for event – free survival was not significantly met, showing a hazard ratio of 0 .88, not meeting the statistically defined threshold of significance. So the curse started to separate smartly. But there is absolutely no benefit from this event-free survival improvement with the pembrolizumab if compared to the placebo. So as the OS and the pathological complete response rate were not statistically significantly, they only have the numerical results. So the OS is no different again. This was, I mean, in line with if you do not observe an EFS benefit. But the pathologic complete response with gemcitabine plus pembrylizumabs was about 44 % in this patient cohort. And that was an absolute 9 % increase. If compared to the placebo. Well, to summarize that, yes, we have a negative trial in this perioperative setting together with gemcitabine cisplatin and an IO therapy. And as you know, on the Congress, there was also the ENERGIS trial being presented. On the other hand, there is the NIAGARA trial using gemcis plus durvalumab. So it would be going very, very deep to discuss any insights why there might be difference between these two, three trials outcome. But at the end, we had to admit KEYNOTE-866 is a negative. trial using this combination. And therefore, we cannot recommend gemcitabine cisplatin plus pembrolizumab in this perioperative setting. Well, on the other hand, we all know enfortumab vedotin plus pemberlizomab is approved by FDA and EMA in this period operative setting, irrespective of platinum eligibility, providing our patients a wide opportunity specifically for muscle invasive bladder carcinoma.
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