Six months after treatment with the radiopharmaceutical therapy, 77.8% of patients with meningioma were alive and had not experienced further disease progression, beating the 26% benchmark established in earlier studies.
Phase II data presented Sunday at the American Society for Radiation Oncology annual meeting suggest Novartis’ Lutathera may improve progression-free survival in patients with tough-to-treat meningioma brain tumors.
Lutathera is a combination of a radionuclide, 177Lu, and a peptide that binds to somatostatin receptors. The combination enables the targeted delivery of radiation therapy. Lutathera received FDA approval for use against gastroenteropancreatic neuroendocrine tumors in 2018. Novartis has yet to expand the label to cover additional diseases but Lutathera is potentially applicable to other tumors that express somatostatin.
That potential informed a Phase II trial led by Kenneth Merrell, a radiation oncologist at the Mayo Clinic Alix School of Medicine. The study was designed to show if Lutathera could be an option for people with meningioma, a brain tumor, who progress after treatment with surgery or radiation.
Researchers have reported recurrence rates of 40% to 80% for certain grade meningiomas. As the tumor recurs, patients quickly run out of safe and effective salvage treatments. Because nearly all meningiomas express somatostatin, the Mayo Clinic oncologist identified Lutathera as a drug that could provide people with another option.
“There is no standard of care or proven option for managing refractory meningioma,” Merrell said in a statement. “Many of these patients continue to experience aggressive tumor growth and significant related complications, and ultimately the illness may prove fatal. It is a very challenging prognosis to manage, and in many cases, we are left with only supportive measures.”
The single-arm study enrolled 20 people with surgery- and radiation-refractory meningioma to receive four administrations of Lutathera eight weeks apart. Six months after treatment, 77.8% of the patients were alive and had not experienced further disease progression. The researchers said earlier studies had established 26% as the benchmark for progression-free survival (PFS) after six months.
Median PFS in the Lutathera study was 10.7 months. The trial had yet to reach median overall survival at the time of the ASTRO analysis. One year after treatment, 88.5% of patients were alive.
No patients experienced grade 4 or 5 adverse events, the most severe side effects, that were attributable to the treatment. Ten patients had moderate, grade 3 hematologic adverse events. There was also one case each of grade 3 hepatitis and seizure that were at least possibly attributable to treatment. Five people stopped taking Lutathera, in two cases because of possible treatment-related adverse events.
