Novartis’ First-in-Class Radioligand Therapy Lutathera Significantly Improves Progression-Free Survival in First-Line Treatment of Advanced GEP-NETs

▎Edited by the WuXi AppTec content team

Today, Novartis announced that the radioligand therapy Lutathera met the primary endpoint in the phase 3 clinical trial NETTER-2. Compared with high-dose long-acting octreotide alone, the combination of Lutathera and long-acting octreotide significantly improved progression-free survival (PFS) in newly diagnosed somatostatin receptor (SSTR)-positive, grade 2 and 3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The press release noted that this isFirst Radioactive Ligand Therapy Demonstrates Clinically Meaningful Benefit in First-Line Treatment.

NETs are a class of cancers originating from neuroendocrine cells throughout the body and are generally considered slow-growing malignancies. However, some NETs progress rapidly with poor prognosis, and in many cases, delayed diagnosis results in patients presenting with advanced disease. Although NETs are a rare condition, their incidence has increased by more than 500% over the past 30 years, creating an urgent need for additional treatment options for newly diagnosed patients with unresectable or advanced disease.

Lutathera is a radioligand drug that binds to somatostatin receptors on the surface of tumor cells, enters the cells, and damages the tumor cells through radiation.. It was approved by the U.S. FDA in 2018 for the treatment of patients with SSTR-positive GEP-NETs who have been previously treated, and isThe First FDA-Approved Radioligand TherapyRadioligand therapy delivers the radiation energy of radioactive isotopes to the interior of tumors, killing the tumors while reducing the impact on healthy cells. This is one of the key technology platforms being developed by Novartis.

The safety data from this clinical trial showed no new or unexpected safety findings, consistent with the well-established safety profile of Lutathera. Specific data will be presented at upcoming medical conferences and submitted to regulatory authorities for discussion.

[1] Novartis radioligand therapy Lutathera® demonstrated statistically significant and clinically meaningful progression-free survival in first line advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Retrieved September 25, 2023, from https://www.novartis.com/news/media-releases/novartis-radioligand-therapy-lutathera-demonstrated-statistically-significant-and-clinically-meaningful-progression-free-survival-first-line-advanced-gastroenteropancreatic-neuroendocrine-tumors-gep-nets