Lu-177 dotatate PRRT (SSTR2-targeted) hits 69% PFS-6 in refractory intracranial meningioma; Ga-68 dotatate PET tracks response

[177Lu]Lu-DOTA-TATE (Lu-177 dotatate) is a somatostatin receptor 2 (SSTR2)–targeted peptide receptor radionuclide therapy (PRRT), paired here with exploratory [68Ga]Ga-DOTA-TATE PET as a functional imaging biomarker, in a single-arm, open-label, multicenter Phase 2 study (NCT03971461) of progressive intracranial meningioma after surgery and radiation (n=32; WHO grade 1/2/3: 7/24/1). Patients received 7.4GBq every 8 weeks ×4; the primary endpoint PFS-6 was 69% (22/32), with MRI best response PR 16% and SD 63%—well above the classic RANO historical PFS-6 benchmarks of ~29% (grade 1) and ~26% (grade 2/3) used for single-arm meningioma trials (though newer pooled “contemporary” benchmarks can run higher depending on included studies). Grade 3/4 AEs were mainly transient cytopenias (47%); 3% discontinued for grade 4 thrombocytopenia, and in a small paired-imaging subset Ga-68 dotatate uptake generally decreased in responding/stable lesions and was broadly concordant with MRI response.