COMMENTARY

CheckMate 067 & Melanoma: 'Amazing Progress', But Not Resting on Laurels

Prof James Larkin

Disclosures

September 29, 2019

My name is James Larkin and I'm a medical oncologist at the Royal Marsden Hospital in London.

I presented the 5 year follow-up from the CheckMate 067 study. This is a randomised trial, which started recruiting in 2013 looking at two nivolumab containing arms in comparison with ipilimumab, which at the time was the standard of care.

The first experimental arm was nivolumab alone. And the second experimental arm was the combination of nivolumab and ipilimumab. Today we have 5 year data from the trial and I guess the headline overall is that 52% of patients treated with the combination were still alive at 5 years. And that's on a background in metastatic melanoma of a situation where 10 years ago when I first started treating the disease, there was no effective drug treatment for metastatic or stage 4 melanoma and average life expectancy was 6 to 9 months. So we've come from that situation in the relatively recent past, to a situation today where I can say to my patients in clinic that there may well be a 50:50 chance of being a long-term survivor of the disease with immunotherapy treatment.

Average life expectancy was 6 to 9 months. So we've come from that situation in the relatively recent past, to a situation today where I can say to my patients in clinic that there may well be a 50:50 chance of being a long-term survivor of the disease with immunotherapy treatment.

Did you suspect you'd get such encouraging results when you started the trial?

I think when we started out on this trial 5 years ago, we could see that the drugs were active, and we were seeing sometimes dramatic responses actually, in patients. But I don't think you ever really have any idea at the beginning of a story like this, how things are going to end up. And in many ways it had been, I think, an aspiration for all of us who were working in the field to develop better treatments for melanoma, but I think most of us have been very pleasantly surprised by how much progress there’s been in a relatively short period of time. But, 50% of people still die of this disease, and so I think that the main issue actually moving forward is we need to try and improve on that and develop better still treatments for our patients.

What are the next steps?

I think for this trial, CheckMate 067, we've got 5 year data, there may be further analyses of the data in the future. But if you look at the survival curves, and the progression-free survival curves, they're really quite flat between years 3 and 5. So I don't think we're expecting to see many further events related to melanoma in terms of progression, or death.

And our experience, we've been using IPI as a single agent now for over 10 years, our experience in the clinic is for people who get up to 5 years, it's very unlikely to have further trouble beyond that. So I think in terms of the analysis of this trial, there's probably not too much more to come in the future. I think most of it is going to be about trying to develop treatments that are effective for the people who don't benefit from the existing treatments. And that’s really where our focus in particular, and for colleagues around the world, that's where we're really focusing our efforts at the moment.

Are there clues from the data why some patients don't benefit from the treatments?

No, I think that's one of the great questions, actually, not just in melanoma, but in every tumour type where we see activity for checkpoint inhibitors: kidney cancer, lung cancer, bladder cancer.

It's wonderful to see responses, but do we really understand why patients are responding and not responding? Well, I think in certain areas there's tantalising clues, and some early data, but in melanoma at the moment in the clinic, I'm afraid we just don't really have a good way of selecting a patient for a particular drug treatment strategy. So again, we've made some progress, but there's a lot more still to do.

I think it has been amazing to see this much progress in this short a period of time but I really don't think we should rest on our laurels.

I think we need to continue to put patients into clinical trials. And in the second half, maybe, of my professional life I’d like to get to a place where we're curing a lot more than 50% of people with this disease.

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