Lutetium Lu 177 Dotatate Reduced Risk of Death By 72% Compared to Comparator in Patients With Advanced GEP-NETs

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Radioligands may be able to deliver radiation to advanced tumor cells anywhere in the body.

Lutetium Lu 177 dotatate (Lutathera; Novartis) plus long-acting release (LAR) octreotidesignificantly improved progression-free survival (PFS) in patients with somatostatin receptor-positive well-differentiated grade 2/3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in the first line setting.

Phase 3 NETTER-2 trial (NCT03972488) results showed lutetium Lu 177 dotatate, a radioligand therapy (RLT) that can deliver radioactive atoms to advanced tumor cells, reduced risk of disease progression or death by 72% compared to high-dose octreotide LAR alone.

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“This is the first positive phase 3 trial of a radioligand therapy in the first-line setting,” said Jeff Legos, global head of oncology development at Novartis, in a press release. “The overall efficacy and safety results are amongst the most clinically relevant observed to date in this kind of advanced cancer, addressing a significant unmet need for patients with newly diagnosed advanced GEP-NETs.”

During the open-label, multi-center, randomized, and comparator-controlled NETTER-2 trial, investigators compared first line treatment of lutetium Lu 177 dotatate plus LAR octreotide to high-dose (60 mg) LAR octreotide alone for the treatment of adult patients with high-proliferation rate tumors (G2 and G3).

The primary study endpoint was PFS, and investigators observed a significantly larger median PFS with lutetium Lu 177 dotatate/octreotide (22.8 months [95% CI: 19.4-not estimable]) compared to LAR octreotide alone (8.5 months [95% CI: 7.7-13.8]). Objective response rate was nearly 5-times greater with lutetium Lu 177 dotatate/octreotide compared to high-dose octreotide LAR alone (43% [95% CI: 35.0-51.3] and 9.3% [95% CI: 3.8-18.3], p<0.0001, respectively).

The most common adverse reactions (any-grade) associated with lutetium Lu 177 dotatate/octreotide and octreotide alone include gastrointestinal issues (nausea, diarrhea, and abdominal). More patients in the lutetium Lu 177 dotatate/octreotide experienced reduced lymphocyte count (grade 3 or higher) compared to the control group (5.4% vs 0%, respectively).

In the United States, lutetium Lu 177 dotatate is currently approved for the treatment of adult patients with SSTR-positive GEP-NETs in the foregut, midgut, and hindgut. In Europe, it is also approved for the treatment of adults with unresectable or metastatic, progressive, and well-differentiated (G1 and G2) SSTR-positive GEP-NETs.

There is currently a portfolio of different RLTs being developed for other cancers, including breast, colon, lung, and pancreatic cancer, according to Novartis. RLTs may have capabilities of delivering radiation to any cell in the body.

“This study confirms the clinical benefit of first line radioligand therapy for newly diagnosed patients living with these types of advanced GEP-NETs,” said Simron Singh, associate professor of medicine at the University of Toronto and cofounder of the Susan Leslie Clinic for Neuroendocrine Tumours at the Odette Cancer Centre in Ontario, Canada, in the press release.“These positive results for lutetium Lu 177 dotatate are practice-changing.”

REFERENCE

Novartis Lutathera significantly reduced risk of disease progression or death by 72% as first-line treatment for patients with advanced gastroenteropancreatic neuroendocrine tumors. Novartis. News Release. January 19, 2024. Accessed January 25, 2024. 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#:~:text=Basel%2C%20January%2019%2C%202024%20%E2%80%93,first%2Dline%20therapy%20in%20patients

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