NETTER-2 Safety Profile | LUTATHERA® (lutetium Lu 177 dotatate)

Safety

NETTER-2 Safety Profile

Adverse events

NETTER-2 safety data are consistent with the established profile of LUTATHERA¹

Adverse Events (Irrespective of Causality) by Preferred Term (≥10% Incidence in Either Arm) (Safety Set)²

Adverse reactions ≥10% with either LUTATHERA + octreotide LAR vs octreotide LAR

The most common adverse events (≥20% in either arm) were nausea (27% vs 18%), diarrhea (26% vs 34%), and abdominal pain (18% vs 27%) for LUTATHERA + 30 mg octreotide LAR vs 60 mg octreotide LAR, respectively¹
The most common grade 3/4 adverse events (>3% in either arm) were lymphocyte count decreased (5% vs 0%), GGT increased (5% vs 3%), small intestinal obstruction (3% vs 0%), and abdominal pain (3% vs 4%) for LUTATHERA + 30 mg octreotide LAR vs 60 mg octreotide LAR, respectively¹
5% of patients discontinued LUTATHERA + 30 mg octreotide LAR due to adverse events vs 3% for patients treated with 60 mg octreotide LAR¹

ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyl transferase; LAR, long-acting release.

Laboratory abnormalities

No new safety signals were reported in NETTER-2^1,3

Incidence of Laboratory Abnormalities (Safety Set)⁴

Laboratory abnormalities with a higher incidence in the LUTATHERA arm, including biochemical abnormalities (eg, increases in alkaline phosphate, AST, ALT, and GGT) and hematological abnormalities (eg, decreases in leukocytes, lymphocytes, platelets).

Incidence based on worst post-baseline CTC grade.⁴

CTC, Common Terminology Criteria.

Next page: NETTER-1 Safety Profile

References: 1. 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. 2. 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)(suppl):2807-2817. 3. Strosberg JR, Caplin ME, Kunz PL, et al; NETTER-1 investigators. ¹⁷⁷Lu-dotatate plus long-acting octreotide versus high-dose long-acting octreotide in patients with midgut neuroendocrine tumours (NETTER-1): final overall survival and long-term safety results from an open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2021;22(12):1752-1763. 4. Data on file. CAAA601A22301 Clinical Study Report. Novartis Pharmaceuticals Corp; 2024.