Novartis Announces Phase III NETTER-2 Trial Success of Lutathera as First-Line Therapy for Gastroenteropancreatic Neuroendocrine Tumors

On September 25, Novartis announced that the Phase III NETTER-2 trial of its radioligand therapy Lutathera had met its primary endpoint. Compared with high-dose long-acting octreotide alone, the combination of Lutathera and long-acting octreotide as a first-line treatment significantly improved progression-free survival (PFS) in newly diagnosed patients with somatostatin receptor (SSTR)-positive, grade 2 and 3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NET). According to the press release, Lutathera is the first radioligand therapy to demonstrate clinically meaningful benefit in first-line treatment.

Neuroendocrine Tumors (NETs) are cancers that originate from neuroendocrine cells throughout the body and are generally considered to be slow-growing malignancies. However, some NETs progress rapidly with poor prognosis, and in many cases, are not diagnosed until the disease has advanced to a late stage. Although NETs are rare diseases, their incidence has increased by more than 500% over the past 30 years, creating an urgent need for more treatment options for newly diagnosed patients with inoperable or advanced stages.

NETTER-2 is the second Phase III trial of Lutathera, bringing clinically meaningful results to patients. Lutathera was approved by the FDA for marketing in 2018, primarily based on the pivotal NETTER-1 trial.

The NETTER-1 trial demonstrated that, compared to high-dose long-acting octreotide therapy, Lutathera combined with long-acting octreotide significantly improved PFS with clinical relevance in patients with SSTR-positive, inoperable midgut neuroendocrine tumors whose disease had progressed despite receiving standard treatment.

"These positive results from Lutathera are remarkable, representing the potential for radioligand therapy to have a significant impact on newly diagnosed advanced GEP-NET patients," said Jeff Legos, Executive Vice President and Head of Global Oncology Development at Novartis. "Exploring the application of radioligand therapy in earlier treatment of cancer patients is part of our broader collaborative efforts. Our goal is to deliver new therapeutic modalities directly and precisely to cancer cells, thereby improving patient outcomes."

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