• 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^1,2

• Lutathera is the first radioligand therapy (RLT) to demonstrate clinically meaningful benefit in a first line setting¹

• Findings to be presented at an upcoming medical meeting and discussed with regulatory authorities, with submissions to follow

• Novartis is investigating a broad portfolio of RLTs, exploring their treatment potential in a range of advanced cancers beyond prostate and GEP-NET, including lung, breast, pancreatic and colon. The company also continues to support the increasing demand for RLTs with expansions at existing manufacturing sites in the U.S. and Europe and a new state-of-the-art facility in Indianapolis, U.S., which is awaiting FDA approval

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 disease^5-7. Even though NETs are a rare (orphan) disease, their incidence has grown over 500% in the last three decades^5-8 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 patients^2,4. 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 treatment^3-4,9.

“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.