DR DRAKE: The Phase III — and actually, all the trials on these — eliminated patients or excluded patients with prior autoimmune disease. And the question that I would ask patients when they’re coming on the trial is, I would say, “Listen. Have you ever had steroids for something autoimmune on a regular basis? So autoimmune disease enough that you had to have steroids — psoriasis, severe arthritis, things like that.” So patients like that were excluded.

Now, to be fair, patients with mild arthritis, nonsteroid requiring, were on these trials. And if you look at the adverse events, some of those cases actually got worse arthritis. That’s certainly better than having your cancer progress. So there’s always, with anything, a risk versus benefit.

Now, when patients have severe autoimmune disease, for example, psoriatic arthritis, which is really a systemic autoimmune disease, this is a challenge, actually, especially a challenge in later-stage disease when you know that they really don’t have any good treatment options and this is about the only option that gives them a chance of long-term survival.

I think what’s going to happen is, patients and physicians are going to have to approach this on a case-by-case basis, really looking at the risk versus benefit. In the first line or earlier on, where there are treatment options, maybe not. But later on, in the later stage of disease and where there’s not as many treatment options that considering the risk of having autoimmune disease, even fatal, it’s still a risk, actually, whereas the risk of having the patient dying from cancer in those cases might be 100%.

So you can say, “Look. You have a 100% chance of dying of cancer within the next 6 to 12 months, whereas we have some risk — and we don’t know the numbers — of having your autoimmune disease flare and being really, really bad.” So in that kind of setting, that’s really a very individualized discussion. I think that’ll have to be discussed.

DR LOVE: Any specific autoimmune disease? I remember we were talking one time about multiple sclerosis. And you seemed, like, real concerned about that.

DR DRAKE: It’s funny. That’s the one that I worry about. It’s basically a T-cell-mediated disease. It’s CNS. So if this flares, it actually can be fatal in some patients. But when I said this to some of my colleagues, they told me that they had actually treated patients with under-control multiple sclerosis. So I don’t really know.

DR LOVE: I know. I’ve heard that. But it scares you.

DR DRAKE: Absolutely.

DR LOVE: What about it is it, specifically?

DR DRAKE: The fact that it’s T-cell mediated. So the way that these drugs work is, they activate T-cells. So multiple sclerosis is very clearly T-cell mediated.

Bladder cancer

Prostate cancer

Renal cell carcinoma

Checkpoint inhibitors