NETTER II Trial Reaches Primary Endpoint

Positive results from the Phase III NETTER-2 trial were reported in September. The NETTER-2 trial is a randomized, multi-center trial evaluating whether Lutathera® plus long-acting octreotide when taken as a first line treatment can prolong progression-free survival in patients with Grade 2 and 3 gastroenteropancreatic neuroendocrine tumors (GEP-NETs) when compared to treatment with high-dose, long-acting octreotide alone. The trial met its primary endpoint finding statistically significant and clinically meaningful progression-free survival in first line treatment with Lutathera® in combination with long-acting octreotide.

Lutathera is a peptide receptor radionuclide therapy (PRRT) that selectively targets the somatostatin receptor (SSTR) found on NET cells and delivers radiation specifically to the cancer cells. This medicine was granted FDA approval in January 2018 for the treatment of SSTR- positive gastroenteropancreatic neuroendocrine tumors based on the results from the Phase III NETTER-1 trial. NETTER-2 opens the possibility for Lutathera in the first line setting (i.e., as a first treatment option).

There were no new or unexpected safety findings during the NETTER-2 trial. The results from this trial will be presented at an upcoming medical meeting and will be discussed with the FDA. Read the press release here.

“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.”