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ASCO 2026 | Phase II trial of lutetium-177 dotatate in advanced intracranial meningioma

Sylvia Kurz, MD, PhD, Yale University School of Medicine, New Haven, CT, presents final results from a Phase II study (NCT03971461) evaluating lutetium-177 dotatate in patients with progressive advanced intracranial meningioma. The primary endpoint of 6-month progression-free survival was met, with the majority of patients achieving disease control and a generally well-tolerated safety profile. Exploratory gallium-68 dotatate positron emission tomography assessments showed promise as an imaging biomarker for treatment response, supporting further investigation of this radiopharmaceutical in meningioma. This interview took place during the 2026 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.

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Transcript

177-lutetium dotatate is a so-called radioligand therapeutic compound. As such, it is an antibody that targets a receptor that is expressed by meningiomas called SSTR2. And on the other side of that antibody, if you will, there is a radioactive substance that’s the 177-lutetium. So the construct binds to the meningioma cells, gets internalized, and radiates the meningioma cells from within...

177-lutetium dotatate is a so-called radioligand therapeutic compound. As such, it is an antibody that targets a receptor that is expressed by meningiomas called SSTR2. And on the other side of that antibody, if you will, there is a radioactive substance that’s the 177-lutetium. So the construct binds to the meningioma cells, gets internalized, and radiates the meningioma cells from within. So together with my study co-chair, Eric Salman, we have conducted a single-arm phase two clinical trial that enrolled 32 patients to this clinical trial. And our results show that the time until the tumors progress is significantly longer compared to historical controls. And this is, in essence, the results of the study. Besides the extension of the PFS-6 interval or the favorable PFS-6 rate, I should say, we also looked at gallium dotatate PET imaging in those patients who received treatments. And we could see that gallium dotatate PET imaging is a promising imaging biomarker. So we’re seeing reductions in tracer uptake in those patients who had responses to the treatment.

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