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GU Cancers 2024 | AMBASSADOR: adjuvant pembrolizumab in muscle-invasive urothelial carcinoma

Andrea Apolo, MD, National Institutes of Health, Bethesda, MD, discusses findings from the Phase III AMBASSADOR trial (NCT03244384) of adjuvant pembrolizumab in patients with muscle-invasive and locally advanced urothelial carcinoma (MIUC) of the bladder, upper tract, or urethra. Patients were stratified based on PD-L1 status, whether they have received neoadjuvant chemotherapy and pathological stage. The two primary endpoints were disease-free survival (DFS) and overall survival (OS). Whilst DFS in the pembrolizumab arm was statistically significant, the co-primary endpoint of OS was not met. This interview took place at the ASCO GU Cancers Symposium 2024 in San Francisco, CA.

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Transcript (edited for clarity)

So this year at GU ASCO 2024, we have a late breaking abstract on the adjuvant AMBASSADOR study of adjuvant pembrolizumab versus observation in patients with muscle invasive urothelial carcinoma...
So this year at GU ASCO 2024, we have a late breaking abstract on the adjuvant AMBASSADOR study of adjuvant pembrolizumab versus observation in patients with muscle invasive urothelial carcinoma. The Alliance AMBASSADOR study is a multicenter study Phase III trial open label where adjuvant pembrolizumab for one year is given to patients with muscle-invasive urothelial carcinoma versus observation. The key eligibility included patients that had muscle invasive urothelial carcinoma and this can be bladder, urethra, renal pelvis, or upper tract. And the patients could have received neoadjuvant chemotherapy. If they did they had to be two or greater lymph node positive disease or have positive margins, or they could have been cisplatinum ineligible. In that case, they should have been PT3 or greater positive margins and or a positive lymph nodes. The patient must have had radical surgery within 4 to 16 weeks of enrollment into the trial. The study stratified patients based on PD-L1 status, whether they received neoadjuvant chemotherapy and their pathologic stage, and it was a dual primary endpoint of disease free survival and overall survival, and key secondary endpoints included PD-L1 status and DFS and OS.
So the the study was positive for one of the dual primary endpoints. And the way that the study was designed is if it’s positive for one endpoint, one primary endpoint, the study is overall positive and adjuvant pembrolizumab improved disease free survival versus observation with median disease free survival of 29 months versus 14 months for the patients in the observation arm. And this was regardless of PD-l1 status with a hazard ratio of 0.69 and a median follow up of 22 months. We also looked at overall survival, and this was an interim analysis of the overall survival And it did not meet the the pre-specified cutoff for improvement in overall survival. But this was immature; The data is still maturing. For final analysis we see that adjuvant pembrolizumab is very active, And it’s a treatment option for our patients now with muscle invasive urothelial carcinoma in the adjuvant setting that are at high risk. So I think that these findings are very exciting and offering a new treatment options for our patients in this setting.

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