[177Lu]Lu-DOTA-TATE in newly diagnosed patients with advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Primary analysis of the phase 3 randomised NETTER-2 study

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Introduction: There is no universally accepted first line (1L) therapy for higher grade, well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Aim(s): The Phase 3 NETTER-2 study (NCT03972488) evaluated 1L [177Lu]Lu-DOTA-TATE (177Lu-DOTATATE) in patients (pts) with Grade (G) 2 and G3 advanced GEP-NETs. This is the first trial to assess 1L RLT in any solid tumor.

Materials and methods: Eligible pts were newly diagnosed with somatostatin receptor-positive G2 or G3 advanced GEP-NETs. Pts were randomized (2:1) to receive 4 cycles of 177Lu-DOTATATE Q8W (4 × 7.4 GBq) plus 30 mg octreotide long-acting release (LAR) Q8W during 177Lu-DOTATATE treatment then Q4W (177Lu-DOTATATE arm), or 60 mg octreotide LAR Q4W (control arm). The primary endpoint was progression-free survival (PFS; central assessment, RECIST 1.1). Objective response rate (ORR) was a key secondary endpoint.

Conference:

Presenting Author: de Herder W

Authors: de Herder W, Halperin D, Myrehaug S, Herrmann K, Pavel M,

Keywords: [177Lu]Lu-DOTA-TATE, Lutathera, Gastroenteropancreatic Neuroendocrine Tumor, NETTER-2,