Novartis' Lutathera® Reduces Risk of Disease Progression in Advanced Gastroenteropancreatic Neuroendocrine Tumors

Novartis, a leading pharmaceutical company, announced positive results from its Phase III NETTER-2 trial, showcasing the effectiveness of Lutathera® (lutetium Lu 177 dotatate) in reducing the risk of disease progression or death by 72% as a first-line treatment for patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The trial compared Lutathera plus octreotide LAR to high-dose octreotide LAR, and the results demonstrated a significant extension in median progression-free survival (PFS) to 22.8 months compared to 8.5 months with the control group.

NETTER-2 is the first positive Phase III trial for a radioligand therapy in the first-line setting, indicating the potential of radioligand therapies in earlier treatment lines. These findings offer new hope for patients with newly diagnosed grade 2 and 3 advanced GEP-NETs, addressing a significant unmet need.

Dr. Simron Singh, Associate Professor of Medicine at the University of Toronto, emphasized the practice-changing impact of these results, stating that the study confirms the clinical benefit of first-line radioligand therapy for patients with advanced GEP-NETs. The data should provide confidence to physicians in considering Lutathera as a first-line treatment for this life-threatening type of cancer.

Jeff Legos, Global Head of Oncology Development at Novartis, highlighted the significance of this trial and its contribution to improving patient outcomes. He expressed the company's commitment to research and develop radioligand therapies in earlier treatment stages or disease progression.

The study showed no new or unexpected safety concerns, aligning with the well-established safety profile of Lutathera. The most common adverse events reported in the Lutathera group were nausea, diarrhea, and abdominal pain. The trial is ongoing to further evaluate secondary endpoints such as overall survival and long-term safety.

Neuroendocrine tumors (NETs) are a type of cancer that originate in neuroendocrine cells throughout the body. While typically slow-growing, some NETs are associated with rapid progression and poor prognosis, often leading to delayed diagnosis. The incidence of NETs has been increasing in recent decades, highlighting the need for continued research into effective treatment options for newly diagnosed patients.

Novartis is at the forefront of radioligand therapy, investigating a broad portfolio of therapies for advanced cancers such as lung, prostate, breast, colon, glioblastoma, and pancreatic cancers. The company's focus on reimagining medicine for patients remains steadfast.

The Phase III NETTER-2 trial data was presented at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium. Novartis' dedication to advancing cancer care through radioligand therapy and its commitment to expanding manufacturing capabilities worldwide further solidify its position as an innovative medicines company.

Novartis continues to make groundbreaking developments in the field of cancer treatment, striving to improve and extend the lives of millions of patients worldwide.