Aurea, thank you so much for joining us on UroToday.
Aurea Molina Diaz: Thank you very much for your invitation.
Zachary Klaassen: So you presented this data this week and basically, before we get into that, just tell us a little bit about CheckMate 274, which was the key trial that led to the approval of adjuvant nivolumab.
Aurea Molina Diaz: Yes. CheckMate 274 is a positive clinical trial that has changed the treatment in muscle-invasive urothelial carcinoma after surgery in patients who have received chemotherapy in the neoadjuvant setting, who has at least a disease and in the others that have not received neoadjuvant chemotherapy.
Zachary Klaassen: The study that you presented this weekend, just tell us about that patient population and what the study design was.
Aurea Molina Diaz: This PrInCIS-NIADY study is conducted by the Spanish Oncology Genitourinary Group, SOGUG. This study is a nationwide multicenter Spanish study that evaluates the real world effectiveness and safety of adjuvant nivolumab in patients with high-risk PD-L1-positive muscle-invasive urothelial carcinoma. On behalf of SOGUG, I want to highlight that our main goal was to see if the benefit showing CheckMate 274 holds up in real clinical practice.
Zachary Klaassen: Absolutely. And how many patients did you have in the study and what were the key results from your findings?
Aurea Molina Diaz: We had almost 400 patients. And the results are highly encouraging because with only 13 months of follow up, we see that our 18-month disease-free survival estimate was 65.6%.
Zachary Klaassen: Excellent.
Aurea Molina Diaz: And the median disease-free survival has not yet been reached. Also, our safety profile was manageable and consistent, and we're only seeing 1% of the patients having effect versus grade 3/4, mainly transaminase and creatinine synthesis. Our patients were older, as you have said, with a mean age of 69.5 versus 65.3 in CheckMate 274. And nearly 75% of our patients were over 65 years versus 26% of the CheckMate 274.
Zachary Klaassen: Great summary. I love real world data because those patients may not be eligible for the trials like CheckMate 274. So based on your data and taking that together with CheckMate 274, how do we counsel our patients in the clinic next week when we go back to work?
Aurea Molina Diaz: Well, we have to see the results. If the results are okay, and we have to see the patient, the comorbidities, we need clinical trials, but we need also see in real world with patients with more comorbidities with more older how this works if they have more toxicity or worse results in the safer survival or overall survival.
Zachary Klaassen: Absolutely. Thank you for the discussion. Any conclusions or take-home points for our listeners?
Aurea Molina Diaz: This PrInCIS-NIADY study reinforces and validates that adjuvant nivolumab is both effective and safe in our real world clinical practice with older and unselected patients.
Zachary Klaassen: Excellent. Congratulations on the work and thank you for joining us in UroToday.
Aurea Molina Diaz: Thank you.