Radioligand therapy extends PFS in neuroendocrine tumor subgroup
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The addition of a radioligand therapy to first-line treatment with long-acting octreotide prolonged PFS for patients with gastroenteropancreatic neuroendocrine tumors, according to the agent’s manufacturer.
Lutetium Lu 177 dotatate (Lutathera, Novartis) is approved in the United States for treatment of somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors, including hindgut, midgut and foregut neuroendocrine tumors among adults.
Neuroendocrine tumors originate in neuroendocrine cells, and a high percentage of patients are diagnosed with advanced disease. Incidence has increased by more than 500% in the past 3 decades, according to a Novartis press release, creating an urgent need for new treatment options for those with advanced or inoperable disease.
The randomized phase 3 NETTER-2 trial evaluated the combination of lutetium Lu 177 dotatate and long-acting octreotide as first-line therapy vs. high-dose (60 mg) long-acting octreotide for patients who had been diagnosed with grade 2 or grade 3 SSTR-positive advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETS). Study participants had been diagnosed within 6 months of study enrollment.
The trial met its primary endpoint, with researchers reporting longer PFS among patients assigned lutetium Lu 177 dotatate and long-acting octreotide. Results also showed a higher objective response rate — a key secondary endpoint — in that group.
Researchers reported no new or unexpected safety findings.
“These positive results for Lutathera are quite remarkable and they represent the potential for radioligand therapy to make a meaningful impact for newly diagnosed patients living with advanced GEP-NETs,” Jeff Legos, executive vice president and global head of oncology development at Novartis, said in the release. “Exploring the use of radioligand therapies in earlier lines of treatment for patients with cancer is part of our larger, collaborative effort to precisely deliver novel treatment modalities directly to the cancer cells to improve patient outcomes.”
Full results from NETTER-2 will be presented at a medical meeting and shared with regulatory authorities, according to the release.