ASCO 2025 | DART: nivolumab and ipilimumab in rare cancers and brain metastases

So we are very excited to present the findings of the brain metastases cohort of our ipilimumab and nivolumab study in patients with rare tumors, which was a SWOG-led federally supported trial, S1609 study. What we found out in this trial was that in rare tumors with those patients who had brain metastases, we found comparable efficacy both in the brain compared to the rest of the body. We already knew that immune checkpoint blockade in trials with pembrolizumab, that there were similar efficacies in extracranially and intracranially. But this was for more common tumors like non-small cell lung cancer or melanoma. And we have never had data for patients with rare tumors. And rare tumors actually comprise 25% of the patients we see in our clinic. So it’s a sizable population although they are small buckets. What we found out for the first time, we have prospective information that in these patients if you are going to use a dual checkpoint inhibitor like ipilimumab combined with nivolumab that you can actually have good outcomes both in patients with brain metastases compared to those who do not have brain metastases. So what we looked at was two aspects which was efficacy that was defined by response rates and then we looked at the toxicity. So what we found out in the study when we use both ipilimumab and nivolumab, the response rates in brain metastases is around 10 to 11%. That was the same response rate we saw in those patients who had extracranial disease. And mind you, it was a very heavily pretreated patient population that did not have a lot of good options. Also, what we found, which was very reassuring, that there was no increase in toxicity in those patients who had brain metastases compared to those who did not because all the time there’s always this perspective that if someone has brain disease will the immunotherapy cause swelling or more side effects in the brain compared to the rest of the body and our trial showed that there was no significant differences in toxicity with the combination in the brain compared to the rest of the body. We have now data that you can treat these patients who you may see in your clinic and if they’re brain metastases you know that the drugs are going to be effective and they are not going to be any more toxic than they would be for having brain mets and now we are also trying to look at can we combine these agents with radiosurgery or forms of radiation which is often used to treat patients with brain metastases.

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