ASCO 2025 | Assessing MB-FUS in the LIMITLESS and LIBERATE trials

So we are very excited to share two trials that we are leading, which is the LIMITLESS trial and the LIBERATE trial. So these trials actually are using a new technology which is called MRI-guided focused ultrasound. Because one of the challenges in the brain traditionally have, we have this lining around the brain called the blood-brain barrier which limits the drug entry into the brain. And as a result, sometimes the drugs can be more effective in the body, may not be as effective in the brain. So now we have this technology with a company called Insightec, Exablate 4000 system, which can use MRI-guided focused ultrasound to non-invasively disrupt the blood-brain barrier. And the beauty of this technology is that it’s non-invasive and the disruption is not permanent. It happens and then the blood-brain barrier reseals itself. So we can go do the procedure, give the patient the drug, and then the next day the blood-brain barrier reseals and the drug can stay in the brain tumor. So we have used this technology in two different trials. In one trial called the Limitless, we are combining it with pembrolizumab and a number of immune checkpoint inhibitors which are approved for patients with non-small cell lung cancer brain metastases. And we are combining it with this focused ultrasound to see if the combination can be more efficacious than the drugs alone. And the second trial is called LIBERATE . And there, one of the other challenges we have in brain tumors is we have used liquid biopsy in other cancers very effectively. But because brain tumors do not shed as much in the circulation because of the blood-brain barrier again, the cell-free DNA, if we take a liquid biopsy, may not be very informative of what’s going on with the brain tumor. So this technology can, again, disrupt the blood-brain barrier and increase the yield of the cell-free DNA. And then as a result, the liquid biopsy that you could do after the procedure may be more informative of what’s going on with the brain tumor. So we have this FDA approval study of 50 patients that is now enrolled. And we are very excited to share about this trial in progress. And hopefully we’ll have the data coming in the next 6 to 12 months. So stay tuned because if we are successful in showcasing that we can double the yield of cell-free DNA, that can really be transformative for the field of brain tumors where we can then start using liquid biopsies more commonly when we treat these patients.

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