Long-Term Data Show Continued Benefit of Lutetium Lu 177 Dotatate for Progressive Midgut NETs: Presented at ENETS

By Jenny Powers

BARCELONA, Spain -- March 13, 2018 -- Lutetium Lu 177 dotatate (Li-dotatate; Lutathera) continues to significantly improve progression-free survival (PFS) and health-related quality of life (QOL) better than high-dose octreotide in patients with progressive midgut neuroendocrine tumours, according to a study presented here at the 15th Annual Conference of the European Neuroendocrine Tumor Society (ENETS).

After 5 years of follow-up, median PFS had not been reached in the Li-dotatate arm compared with 27.4 months in the high-dose octreotide arm (hazard ratio [HR], 0.21; P< .0001).

The median OS was still not reached with Li-dotatate versus 27.4 months with octreotide (P< .0148).

“There are very few effective treatment options for patients with inoperable, advanced GEP-NETs who are progressive on somatostatin analogues,” said Jonathan Strosberg, MD, Moffitt Cancer Center, Tampa, Florida. “As a medical oncologist seeing more than 500 patients with NETs each year, I am grateful to have [Li-dotatate] as a tool in my arsenal.”

The phase 3 NETTER-1 trial compared Li-dotatate with high-dose octreotide for patients with grade 1 or 2 metastatic midgut NETs and demonstrated a 79% reduction in the risk of progression or death with Li-dotatate over octreotide. A total of 229 patient who had progressed on standard-dose octreotide were randomised to Li-dotatate (n = 116) or high-dose octreotide (n = 113).

The primary endpoint of the study was PFS. Secondary endpoints included objective response rates (ORR), OS, and safety.

The health-related QOL time to deterioration (TTD) was significantly longer with Li-dotatate than with octreotide, including the global heal status (P < .0147), physical functioning (P< .001), role functioning (P< .029), fatigue (P< .029), pain (P< .024), diarrhoea (P< .0107), disease related worries (P< .0176), and body image domains (P< .0058).

“Other domains did not reach statistical significance but the tendency toward longer TTD favoured the Li-dotatate arm,” said Dr. Strosberg.

The US Food and Drug Administration (FDA) had granted a priority review designation to a new drug application for Li-dotatate in June 2016, but requested additional data in November 2016, including new subgroup data, a safety update, and that revisions be made to the previously submitted data. The letter did not request the initiation of additional studies of Li-dotatate.

“This supplement analysis again shows a clinically and statically meaningful PFS benefit with Li-dotatate and also demonstrates that Li-dotatate provides a significant quality of life benefit for patients compared to high-dose octreotide,” said Dr. Strosberg.

Funding for this study was provided by Advanced Accelerator Applications.

[Presentation title: Overall Survival, Progression-Free Survival and Quality of Life Updates From the NETTER-1 Study: 177 Li-Dotatate vs High Dose Octreotide in Progressive Midgut Neurondocrine Tumors. Abstract K22]

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