Perspectives from David Cella, PhD, presenter of CheckMate-9ER Trial
Results from the CheckMate-9ER Trial presented at ASCO GU demonstrate the value of combination nivolumab and cabozantinib as first-line treatment for advanced and metastatic renal cell carcinoma. Dr. Giles: All right. Thank you very much for joining us professor seller. So we’ve seen some very nice data with regards to the, uh, progression-free survival and overall survival and the CheckMate-9ER, but at the ASCO this year, you actually presented some data regarding the health related quality of life data.
Dr. Cella: Well, let me put this into a little context. So of course this is first-line treatment for advanced and metastatic renal cell carcinoma. And the interesting thing about this particular study in these results, is that, whereas historically in oncology, it’s usually the case that more effective therapies because they tend to add a drug to an existing combination, ended up having more toxicity. So the side effects that patients will, um, will be bothered by. Uh, and therefore what we find [00:01:00] often is that we have a more clinically effective treatment that also at the same time is a little harder on patients.
In this case, that’s not what we found at all. We actually found that the newer more effective combination of nivolumab and cabozantinib was not only clinically superior in terms of progression-free survival and overall survival, but it actually was superior to sunitinib from the patient’s perspective in terms of their symptoms and side effects.So we got a win-win basically.
What were the sorts of tools you used to measure this?
Well we use some sort of very basic questionnaires. One is called the Fact Kidney Symptom Index, or FKSI-19, and another is what we call a health preference questionnaire, the EuroQOL 5 item measure of value that one places on their overall health [00:02:00]. In both cases with the FKSI rate and with the EQ-5D – or your quality instrument – we found that the nivolumab/cabo combination was superior over the almost two years of follow up.
Can you speak to how would you place this in perspective with other trials or similar sorts of studies that have compared to these kinds of arms and trials?
Yes. In immune oncology, these immunotherapy oriented drugs have really revolutionized cancer care and in particular renal cancer care. So the news is very good for people with kidney cancer, relative to where things were15, 20 years ago. So it’s very exciting to see that people can not only do better live longer, but they can also not [00:03:00] have as many of the adverse effects. It’s not that these treatments are without adverse effects. They do have some, but they’re not as harsh as some other treatments.
Another unique thing about the treatments these days is that some of the standard measures of, of disease progression, you know, looking at the tumor, getting larger or a new one showing up in a new place, it’s not always necessarily a reason to stop with therapy. So if somebody is doing well, they can continue on the therapy, and in many cases get continued benefit.
Excellent. What are the next steps with, regarding to this study? Are there additional subsets that need to be analyzed for health, health related quality of life?
Well, the next step for this particular study is to look at the overall picture that is to put it all together. So, what we did in the ASCO GU presentation was we looked at the patient perspective and found that the nivolumab – cabo arm was superior to sunitinib, [00:04:00] over time and also further delayed the time to worsening of the symptoms and that’s fine, but what we have not yet done and will do in the near future is take those data and combine them with the clinical data and see if they sort of overall picture, have you putting it all into one analysis shows the same kind of benefit, or maybe perhaps even more benefit.
Thank you.
Cella D et al. Patient-reported outcomes of patients with advanced renal cell carcinoma (aRCC) treated with fi rst-line nivolumab plus cabozantinib
versus sunitinib: The CheckMate 9ER trial. ASCO Genitourinary Cancers Symposium, abstract 285, 11–13 February 2021.
