Targeting Trop-2 in Advanced Urothelial Carcinoma - Episode 5
Considerations for incorporating adjuvant nivolumab into treatment plans for appropriate patients with advanced urothelial carcinoma based on early, recently presented data.
Petros Grivas, MD, PhD: This is a great discussion. I appreciate that, along with the plethora of data. The other big question is in the adjuvant setting before we go to metastatic disease. You mentioned before that we have some interesting data in the adjuvant setting. We have CheckMate 274, which showed statistically significant disease-free survival benefit with adjuvant nivolumab vs placebo. It was a positive trial. However, we haven’t yet seen overall survival data from that study. The FDA and EMA [European Medicines Agency] are still reviewing the data.
Now we have a negative trial with atezolizumab vs observation, the IMvigor010, with some very interesting data with circulating tumor DNA [ctDNA] as an exploratory biomarker. While we’re waiting to see what the FDA, EMA, and other regulatory agencies will do regarding adjuvant nivolumab, we’re trying to enroll in adjuvant trials like AMBASSADOR with adjuvant pembrolizumab vs observation. This is an NCTN [National Clinical Trials Network]–driven trial with Dr [Andrea] Apolo being the PI [principal investigator]. We also have other trials, like PROOF 302 with Dr [Sumanta] Pal and Dr [Siamak] Daneshmand, testing adjuvant infigratinib vs placebo in patients with FGFR3 mutation or fusion. This trial is ongoing. Do you have any comments about this landscape? Do you foresee nivolumab being approved? How will it fit in the treatment paradigm if it gets approved based on CheckMate 274?
Neeraj Agarwal, MD: It will be a great discussion after it’s approved. I would defer in that we’re looking forward to discussing the metastatic disease, but all these are very exciting news. There’s the AMBASSADOR trial with pembrolizumab, the impending approval of nivolumab, and the recent paper in Nature showing that patients selected by ctDNA had improved outcomes with atezolizumab. Dr Thomas Powles was the first author, and you were 1 of the authors. All these are very exciting for our patients, but we need to wait for the approval in my view before we even contemplate patient characteristics or patient selection and further discussion. But I’m really looking forward to those discussions.
Transcript edited for clarity.