NEW YORK – Novartis on Monday announced it is planning regulatory submissions for Lutathera (lutetium Lu 177 dotatate) after a clinical trial showed that certain patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) benefited more from the radioligand therapy combined with long-acting octreotide than with octreotide alone.
In the Phase III NETTER-2 trial, patients with newly diagnosed somatostatin receptor (SSTR)-positive, grade 2 and 3 advanced GEP-NETs lived longer without their cancers progressing when they received Lutathera-octreotide than with single-agent octreotide.
Lutathera is already approved in the US and EU for patients with SSRT-positive GEP-NETs based on data from the Phase II NETTER-1 trial, in which patients received octreotide with or without the radioligand treatment after progressing on standard-of-care therapies. The NETTER-2 trial is the first to show a radioligand therapy's benefit in the first-line setting, according to Novartis.
The company will present detailed results from NETTER-2 at an upcoming medical conference and will plan regulatory submissions after discussing the data with regulatory authorities.
"These positive results … represent the potential for radioligand therapy to make a meaningful impact for newly diagnosed patients living with advanced GEP-NETs," Jeff Legos, executive VP and global head of oncology development at Novartis, said in a statement. "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."
As Novartis has advanced its radioligand therapy pipeline in recent years, the demand for such treatments has at times outpaced its manufacturing capacity. Accordingly, Novartis has been opening new facilities to make radiopharmaceuticals including in Millburn, New Jersey; Zaragoza, Spain; and Ivrea, Italy. Novartis said in a statement that it anticipates another manufacturing facility in Indianapolis will be operational later this year.