Dr Kurz on the Efficacy and Safety of Lutetium Lu 177 Dotatate in Advanced Intracranial Meningioma

"The key take-home message from the phase 2 clinical study...was that we were able to show significantly improved PFS with lutetium Lu 177 dotatate at 6 months over [that of] historical controls."

Sylvia C. Kurz, MD, PhD, the interim section chief for Neuro-oncology and co-director of the Chenevert Brain Tumor Center at Yale Cancer Hospital, highlighted data from a phase 2, single-arm study (NCT03971461) evaluating lutetium Lu 177 dotatate (Lutathera) in advanced and treatment-refractory intracranial meningiomas and discussed how these data support the agent's investigation in the ongoing phase 2 MOMENTUM-1 trial (NCT06955169).

Lutetium Lu 177 dotatate is a SSTR2-targeting radioligand therapeutic agent with prior activity in other neuroendocrine tumors and oncological entities.

Data from the phase 2 study presented at the 2025 Society of Neuro-Oncology Annual Meeting support the agent’s continued investigation, showing a 6-month progression-free survival (PFS-6) rate of 69% in this patient population (n = 32), Kurz reported. In patients with World Health Organization (WHO) grade 1 (n = 7) and grade 2 (n = 25) meningiomas, the PFS-6 rates were 71% and 68%, respectively. Best radiographic response with lutetium Lu 177 dotatate included partial responses in 16% of patients and stable disease in 20%.

These PFS rates represent a significant improvement compared with that of historical benchmarks, Kurz noted, who also highlighted that treatment with the agent was found to be well tolerated.

Based on these encouraging data, lutetium Lu 177 dotatate is being further explored in patients with progressive grade 1 through 3 intracranial meningiomas in the phase 2, randomized, open-label MOMENTUM-1 trial. In MOMENTUM-1, patients will be randomly assigned 2:1 to receive either lutetium Lu 177 dotatate or investigator’s choice of standard-of-care (SOC) therapy. Notably, at the time of progression, participants on the SOC arm may cross over to the alternative treatment arm.