Novartis Reports Positive Phase 3 Data for First-in-Class Lutathera, Reducing Risk of Disease Progression or Death by 72% in First-Line GEP-NETs

Jan 24, 2024 07:29 CST Updated 07:30

Novartis

Drug Development and Manufacturing

▎WuXiEdited by Kant Content Team

Recently, Novartis announced its Phase 3New data from the bed trial NETTER-2. The results show,Compared with high-dose long-acting octreotide alone（octreotide）In comparison,Lutathera Combined with Long-Acting Octreotide as First-Line Treatment for Patients with Somatostatin Receptor (SSTR)-Positive, Well-Differentiated Grade 2 and Grade 3 Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)Patient,Reduced the risk of disease progression or death by 72% in patients. NewThe press release pointed out,NETTER-2Is the first to use radioactive ligandsPhase 3 Clinical Trial of RLT as a First-Line Treatment Yields Positive Results,Demonstrated the potential of RLT in frontline treatment.

The safety data from this clinical trial showed no new or unexpected safety findings, consistent with the well-established safety profile of Lutathera. The majority of patients (88%) in the Lutathera treatment group received all four cycles of Lutathera treatment. Compared to the control group, the most common adverse events of any grade (≥20%) in the Lutathera treatment group were nausea (27.2% vs 17.8%), diarrhea (25.9% vs 34.2%), and abdominal pain (17.7% vs 27.4%). The most common Grade ≥3 adverse events (>5%) were decreased lymphocyte count (5.4% vs 0%).

▲Summary of Efficacy Results from the NETTER-2 Trial (Image Source: Reference [1])

Currently, the NETTER-2 trial is ongoing to further evaluate secondary endpoints, including overall survival and long-term safety.

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 United States in 2018FDA ApprovalTreatment of pretreated SSTR-positive GEP-NETs patients, 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.

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References:

[1] Novartis Lutathera® significantly reduced risk of disease progression or death by 72% as first-line treatment for patients with advanced gastroenteropancreatic neuroendocrine tumors. Retrieved january 22,2024, from https://www.novartis.com/news/media-releases/novartis-lutathera-significantly-reduced-risk-disease-progression-or-death-72-first-line-treatment-patients-advanced-gastroenteropancreatic-neuroendocrine-tumors

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