NETTER-1: A Pivotal Trial of LUTATHERA® (lutetium [177Lu] oxodotreotide)
NETTER-1 is an open-label, phase III trial of patients with advanced, well-differentiated, progressive, somatostatin receptor (SSTR)-positive midgut neuroendocrine tumours (NETs), who were randomised to receive [177Lu]Lu-DOTA-TATE plus best supportive care, consisting of 30 mg octreotide long acting repeatable (LAR) every 4 weeks or to receive 60 mg octreotide LAR every 4 weeks.1 In the interim analysis, 177Lu-DOTATATE plus octreotide LAR 30 mg (n=116) significantly prolonged median progression-free survival (PFS) vs octreotide LAR 60 mg (n=116; not reached vs 8.5 months; HR of 0.18 95% CI: 0.11, 0.29; p<0.001).2
This slide deck describes the trial design and summarises the toxicity profile and outcomes from the primary analysis.
LUTATHERA® is indicated for the treatment of unresectable or metastatic, progressive, well-differentiated (G1 and G2), somatostatin receptor positive GEP-NETs in adults.2
Please note, octreotide 60mg is not the licensed dose in Great Britain.
CI, confidence interval; GEP-NET, gastroenteropancreatic neuroendocrine tumor; HR, hazard ratio; LAR, long acting repeatable; NETs, neuroendocrine tumours; PRRT, peptide receptor radionuclide therapy; RR, relative risk; SmPC, summary of product characteristic; SSTR, somatostatin receptor.
*This is reported as 79% in Strosberg et al;1 the 82% figure (found in the SmPC) is due to the inclusion of additional scans at the request of the regulatory authorities.
