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Start strong with LUTATHERA for SSTR+ GEP-NETs

NETTER-2 is a phase 3, randomized, open-label, active comparator, multicenter study of the efficacy of LUTATHERA with 30 mg octreotide LAR (n=151) vs 60 mg octreotide LAR (n=75) in patients with newly diagnosed, well-differentiated, grade 2/3 advanced SSTR+ GEP-NETs. SSA-naive patients were eligible, as well as patients previously treated with SSAs in the absence of progression. The primary end point of the study was centrally assessed PFS. The median PFS in the LUTATHERA arm was 22.8 months (95% CI, 19.4-NE) vs 8.5 months (95% CI, 7.7-13.8) in the control arm.1,4,*

NETTER-1 was a pivotal, phase 3, randomized, multicenter, open-label study of LUTATHERA with 30 mg octreotide LAR (n=116) vs 60 mg octreotide LAR (n=113) in patients with locally advanced, inoperable, or metastatic grade 1/2 SSTR+ GEP-NETs after progression on an SSA. The primary end point of the study was centrally assessed PFS. The median PFS in the LUTATHERA arm was not reached at primary analysis (95% CI, 18.4-NE) vs 8.5 months (95% CI, 6.0-9.1) in the control arm.2,3,5,*

*Defined as the time from randomization to first documented disease progression (centrally assessed according to RECIST v1.1) or death due to any cause.1

GEP-NETs, gastroenteropancreatic neuroendocrine tumors; LAR, long-acting release; NE, not evaluable; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors; SSA, somatostatin analogue; SSTR+, somatostatin receptor-positive.

References: 1. Data on file. Novartis Pharmaceuticals Corp; 2021. 2. Lutathera. Prescribing information. Novartis Pharmaceuticals Corp. 3. Strosberg J, El-Haddad G, Wolin E, et al; for the NETTER-1 trial investigators. Phase 3 trial of 177Lu-dotatate for midgut neuroendocrine tumors. N Engl J Med. 2017;376(2):125-135. 4. Singh S, Halperin D, Myrehaug S, et al. [177Lu]Lu-DOTA-TATE plus long-acting octreotide versus high-dose long-acting octreotide for the treatment of newly diagnosed, advanced grade 2-3, well-differentiated, gastroenteropancreatic neuroendocrine tumours (NETTER-2): an open-label, randomised, phase 3 study. Lancet. 2024;403(10446):2807-2817. 5. US Food and Drug Administration. FDA approves new treatment for certain digestive tract cancers [press release]. Updated January 26, 2018. Accessed July 26, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-certain-digestive-tract-cancers