Phase III NETTER-2 trial met primary endpoint of improvement in progression-free survival (PFS) and key secondary endpoint of objective response rate (ORR) in patients with Grade 2 and 3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who received first line treatment with Lutathera in combination with long-acting octreotide, versus high-dose long-acting octreotide alone
Laboratory building (Virchow 6) on Novartis Campus. (Credit: Novartis AG)
Today, Novartis announced the Phase III NETTER-2 trial with Lutathera met its primary endpoint. First line treatment with Lutathera in combination with long-acting octreotide demonstrated a significant improvement in progression-free survival (PFS) in patients with newly diagnosed somatostatin receptor (SSTR)-positive, Grade 2 and 3, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) versus high-dose long-acting octreotide alone1,2. No new or unexpected safety findings were observed in the study and data are consistent with the already well-established safety profile of Lutathera1-4.
NETs are a type of cancer that originate in neuroendocrine cells throughout the body and are commonly considered slow-growing malignancies. However, some NETs are associated with rapid progression and poor prognosis and in many cases, diagnosis is delayed until patients have advanced disease5-7. Even though NETs are a rare (orphan) disease, their incidence has grown over 500% in the last three decades5-8 and there is an urgent need for additional treatment options for patients newly diagnosed with inoperable or advanced disease.
With these results, NETTER-2 is Lutathera’s second Phase III trial showing clinically meaningful results for patients2,4. The approval of Lutathera was originally based on the pivotal NETTER-1 trial, which demonstrated highly significant and clinically meaningful PFS prolongation for patients treated with Lutathera in combination with long-acting octreotide versus high-dose (60 mg) long-acting octreotide for SSTR-positive, inoperable midgut neuroendocrine tumors (NETs) who were progressing despite standard treatment3-4,9.
“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,” said Jeff Legos, Executive Vice President, Global Head of Oncology Development at Novartis. “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.”
The findings from NETTER-2 will be presented at an upcoming medical meeting and discussed with regulatory authorities.
Source: Company Press Release