Hope for those battling advanced intracranial meningioma? A recent Phase 2 study offers promising news, suggesting a new treatment could significantly improve outcomes. Let’s dive in!
The study focused on Lutetium Lu 177 dotatate (177Lu-Dotatate), a radiopharmaceutical. The results, presented at the 2025 Society for Neuro-Oncology Annual Meeting, revealed that 177Lu-Dotatate showed a favorable safety profile in patients with advanced intracranial meningioma. But here’s where it gets exciting: the 6-month progression-free survival (PFS) rate exceeded expectations.
The study’s findings are impressive. The 6-month PFS rate with 177Lu-Dotatate was an impressive 69%, surpassing historical benchmarks. Breaking it down further, 71% of patients with grade 1 tumors and 68% of those with grade 2/3 tumors remained progression-free at the 6-month mark. These numbers are a significant improvement compared to historical controls, where 6-month PFS rates ranged from 29% to 43.6% for grade 1 tumors and 26% to 38% for grade 2/3 tumors.
Moreover, the best radiographic response, as assessed by MRI and RANO criteria, showed a partial response in 5 patients and stable disease in 20 patients. The median PFS with 177Lu-Dotatate was 12.8 months, and the median overall survival (OS) was 25.3 months.
Dr. Sylvia C. Kurz, the lead researcher, emphasized that the key takeaway was the significantly improved PFS with 177Lu-Dotatate compared to historical controls.
So, what was this study all about?
The study enrolled adult patients (aged 18+) with progressive WHO grade 1 to 3 meningioma. They needed to have measurable disease and evidence of SSTR2 expression. Patients received four doses of 177Lu-Dotatate, administered 8 weeks apart. The primary goal was to assess the 6-month PFS rate, with secondary endpoints including safety, 12-month OS rate, objective response rate (ORR), median OS, and median PFS.
The study included 32 patients. The median age was 65.5 years, and most patients were female (66%). Regarding the tumor grade, 22% had grade 1, 75% had grade 2, and 3% had grade 3 disease. Tumor locations varied, with the convexity (50%), skull base (38%), or both (13%) affected. Half of the patients had multiple tumors.
And this is the part most people miss… The patient population had been heavily pretreated. 44% of patients had undergone one prior biopsy/resection, and 56% had more than one surgical intervention. Also, 44% had received one course of radiation, and 56% had received one or more prior courses of radiation.
What about the side effects?
Dr. Kurz noted that the drug was generally well-tolerated. The most common adverse effects (AEs) included alopecia, cytopenias (such as anemia, leukopenia, lymphopenia, neutropenia, and thrombocytopenia), nausea or vomiting, anorexia, elevated transaminase levels, electrolyte abnormalities, hyperuricemia, elevated amylase levels, elevated lactate dehydrogenase levels, elevated creatinine levels, diarrhea, cardiac arrhythmic events, and fatigue. The main AEs were bone marrow suppression with cytopenias and electrolyte derangements.
What’s next for 177Lu-Dotatate?
The promising results have led to the development of the phase 2 MOMENTUM-1 trial, a national multicenter study. This study will compare 177Lu-Dotatate to the standard of care.
Controversy & Comment Hooks: Could this new treatment truly revolutionize the way we manage advanced intracranial meningioma? Do you think the historical benchmarks accurately reflect the challenges faced by patients with this condition? Share your thoughts below!