Giuseppe Saglio presented the early data from the Novartis ENESTnd study of first-line Nilotinib. Involving 846 patients, this was a 3 arm study: nilotinib 300 bid, 400 bid, and imatinb 400 od – 1:1:1 randomisation. At 12 months MMR rates in the three arms (in order indicated above) were 44%, 43% and 22%. CCR rates were 80, 78, 65%. So it seems that nilotinib is producing better early responses than imatinib – perhaps not a surprise but the first time this has been demonstrated. One slightly odd thing was the ‘low’ rate of MMR in the imatinib arm at 22%: in the TOPS study [abstract 337] at 12 months the MMR rate was 40%. These are not directly comparable of course but it is still a sizeable difference.

This study is quite exciting but very preliminary and in this authors’ view does not warrant a change in first line therapy just yet. We have seen a number of studies, the TOPS study of 800 vs 400 imatinib [abstract 337] is a good example, where there were significant differences between arms early on but with further follow up these differences disappeared and no significant difference in survival was seen. Robust long term studies are required to see whether these early differences in MMR are maintained and whether survival improvements with the new drug can be achieved without undue longer term side effects. Expect first-line dasatinib data to be released at ASCO in 2010.

As a side note, the SPIRIT team have lobbied to have nilotinib included in SPIRIT 2, so far without success. It would be very timely now to perform an imatinib vs dasatinib vs nilotinib comparison and perhaps NICE will demand this in due course. There was an update on the MD Anderson single arm first line use of second generation TKIs: dasatinib [338] and nilotinib [341].

The data for both continue to look promising with, I think, little to choose between them at this stage. There wasn’t much on second line dasatinib and nilotinib, a topic close to the hearts of Brit haematologists in view of recent NICE ACD.