ASCO 2025 | DANTE: comparing 1 versus 2 years of anti-PD1 therapy in melanoma

DANTE was looking at whether we could reduce the amount of immunotherapy that we’re giving for advanced melanoma. So at the moment, we give at least two years of immunotherapy, PD-1 based treatment. And some people carry on beyond that. But you know, that’s a huge ask of patients and healthcare systems to be able to do that. And the financial toxicity is also high as well. So DANTE was asking about whether we could give less than that. So a year of treatment with immunotherapy without a significant decrease in efficacy and continuing to be acceptable to both patients and clinical teams as well. So we designed DANTE with patients and with the clinical teams as well. And we got to the stage that we were going to give the first year of treatment and then randomize the patients at that time if they wanted to, and they were progression-free to either continue the treatment or to stop at that point and restart if they had progression. So, we did that. And it was quite a challenging study to recruit to. The pandemic came almost as soon as we opened, which made it much harder. And we tried various strategies to keep going. There was still a huge amount of interest. There’s still interest, as you could probably see at ASCO this year. But it meant that actually we didn’t manage to recruit to all the patients that we wanted to. So we recruited 166 of the planned 1,208. But it is the largest trial so far in this particular area, the first one to read out, and it does give us some interesting information. So it was a non-inferiority trial because otherwise it would have been too enormous to do. And we designed it with patients and they said they would accept a drop of up to 6% in efficacy if it meant that it was better in other ways. And what we found was that even with 166 patients, it was non-inferior to give a year of treatment as opposed to longer. But, of course, with it being underpowered, we have to say to people, right, take this, add it to your evidence so far, but for the moment, we can’t recommend that you give less treatment. So two years or more is still the standard of treatment, but if you’re having a one-to-one conversation with your patient, then you might bring this information into the mix. There’s not a huge difference between one year and two years of treatment. So that’s how it is at the moment. We’ve still got more analyses to do. So we presented the progression-free survival. We presented the overall survival, the number of deaths so far. We represented the toxicity, which shows that yes, you do get more side effects if you carry on with the treatment. So 25% severe side effects if you carry on compared to 8% if you stop. We showed the quality of life is very similar in the two arms, regardless of whether you’re on the treatment or not. The things that we now need to look at are how long the responses last for the patients who get and whether stopping earlier reduces the duration of response. And we’re also doing the health economics analysis as well, because as I say, the financial side of things is going to be very, very important to patients and healthcare systems as well. So, that’s where we’ve got to with the data that was presented so far.

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