Six months post-treatment with the radiopharmaceutical therapy, 77.8% of meningioma patients survived without further disease progression, surpassing a previous benchmark of 26% established in earlier studies. This promising finding was presented at the American Society for Radiation Oncology annual meeting, suggesting that Novartis' Lutathera might enhance progression-free survival in patients with challenging-to-treat meningioma brain tumors.
Lutathera is a combination of a radionuclide, 177Lu, and a peptide that binds to somatostatin receptors, enabling targeted radiation therapy delivery. It was approved by the FDA in 2018 for treating gastroenteropancreatic neuroendocrine tumors. Although Novartis has not yet expanded its use to other conditions, Lutathera's potential applicability to additional tumors expressing somatostatin is significant.
This potential led to a Phase II trial conducted by Dr. Kenneth Merrell, a radiation oncologist at the Mayo Clinic Alix School of Medicine. The study aimed to determine whether Lutathera could serve as a treatment for meningioma patients who had not responded to surgery or radiation. Meningioma is a type of brain tumor with recurrence rates ranging from 40% to 80% in certain grades. As these tumors recur, patients often run out of safe and effective treatment options.
"Refractory meningioma has no standard of care or proven management options," stated Dr. Merrell. "These patients frequently experience aggressive tumor growth and severe complications, ultimately facing a fatal prognosis. Managing this condition is very challenging, often leaving us with only supportive measures."
The single-arm study involved 20 patients with meningioma resistant to surgery and radiation. They received four doses of Lutathera, administered eight weeks apart. Six months after the treatment, 77.8% of the patients were alive without further disease progression, significantly higher than the 26% benchmark from previous studies.
The study revealed that the median progression-free survival (PFS) was 10.7 months. At the time of the analysis, the trial had not yet reached median overall survival. One year post-treatment, 88.5% of the patients were still alive. Importantly, no patients experienced severe grade 4 or 5 side effects related to the treatment. Moderate grade 3 hematologic adverse events occurred in ten patients, and there was one case each of grade 3 hepatitis and seizure potentially linked to the treatment. Five patients discontinued Lutathera, with two stopping due to possible treatment-related adverse events.
The findings indicate that Lutathera could offer a new treatment possibility for patients with refractory meningioma, providing hope for a condition that currently lacks effective management options. Further research and trials may solidify Lutathera's role in treating this challenging brain tumor, potentially improving the prognosis and quality of life for many patients.
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