Thank you very much. Good morning and thank to ESMO Press Committee to have selected this presentation. I’m going to present to you the data, main data, for CheckMate 214. This is my disclosure.
As you probably know, CheckMate is one of the first combination studies of immunotherapy tested in first line in kidney cancer to be reported. This study looked at a combination of nivolumab and ipilimumab at the doses which have been developed in the phase I: 3mg/kg of nivo plus 1mg/kg of ipi every three weeks followed by continuing treatment with nivolumab every two weeks versus sunitinib as a control arm at the standard dose here. Patients were stratified by risk group and region and treatment was continued until progression or unacceptable toxicity.
This study was made to have three co-primary endpoints in intermediate and poor risk patients based on previous observations in this group of patients. So objective response rate, PFS and OS were co-primary endpoints and the hazard ratio was split between these three co-primary endpoints to get significance. We estimated that we needed more than 1,000 patients to get to our goal and 820 should be intermediate or poor risk by IMDC criteria. We also had a list of co-primary endpoints, some of them will be presented today, some will be presented later on, but, as you can see, we also have an intent to treat analysis. We have an analysis in good risk patients, we also have some outcome by PD-L1 expression that we’ll show this afternoon and quality of life data which will also be interesting to see.
Let’s go to the first co-primary endpoint, response rate and PFS. As you can see, response rate is highly significant in intermediate and poor risk patients, 42% versus 27% which is highly significant in terms of p-value. Interestingly, you can see that duration of response is much longer with ipi/nivo than it is with sunitinib; median duration is not reached yet with nivo/ipi here.
This is overall survival. Just to let you know, these numbers are still under embargo. They are not contained in the late breaking abstract which was released from embargo this morning but please keep this data confidential until the Presidential Symposium. That’s why I did not put the hazard ratio but, as you can see, it’s highly significant in the intermediate and poor risk patients here.
The same in intent to treat analysis where still though I see significance you can see that the response rate is still significant, not to the same extent that it is and PFS now is not significant in the intent to treat analysis.
One important question about this combination is whether the toxicity is manageable. As you can see on this slide which is, of course, like all these toxicity slides, quite busy, overall the toxicity of sunitinib in terms of grade 3/4 is higher than it is with nivo/ipi. We have the classical toxicities that we know with sunitinib and also with nivo/ipi but overall toxicity is less with nivo/ipi which translates, interestingly, into a better quality of life and less symptoms in patients treated with nivo/ipi which is good news for all our patients here.
My main conclusion from this study is that the safety profile of nivo/ipi is manageable and consistent with what we know. We have more high grade related adverse events with sunitinib, we have better symptom control with nivo/ipi and certainly these results support nivo/ipi to become the new first line standard of care for patients with advanced renal cell carcinoma.
Thank you very much.