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This was a phase 2 study of lutetium-177 (177Lu) dotatate in patients with surgery- and radiation-refractory meningioma. 177Lu-dotatate is a targeted treatment that uses a radioactive compound to deliver radiation directly to tumor cells.
The single-arm trial enrolled 20 patients with WHO grade 2/3 meningiomas who had measurable disease with at least 15% tumor growth over 6 months and a Krenning score ≥ 2. The study met its primary endpoint; the 6-month progression-free survival (PFS) rate of 77.8% was significantly greater than the 26% historical benchmark. Overall median PFS was 11.5 months, and the 2-year PFS rate was 26.7%. The 1-year overall survival (OS) rate was 88.9%, and the 2-year OS rate was 63.8%. Median OS was 27.8 months.
The treatment was well tolerated, with no grade 4 or 5 adverse events attributed to the treatment. The most common grade 3 hematologic adverse event was low lymphocyte count.
There is currently no standard of care established for surgery- and radiation-refractory meningioma, so this study is a promising step forward.