Advanced Accelerator Applications S.A. announced the New England Journal of Medicine published the results of the NETTER-1 Phase III study evaluating efficacy and safety of Lutathera (lutetium-177 dotatate) to treat midgut neuroendocrine tumors.

Advanced Accelerator Applications S.A. announced that the New England Journal of Medicine published the results of the NETTER-1 Phase III study evaluating efficacy and safety of Lutathera (lutetium-177 dotatate), an investigational drug, in patients with advanced, progressive somatostatin receptor-positive midgut neuroendocrine tumors (�NETs�). In this study, the primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), overall survival, safety, and tolerability.

The NETTER-1 study met its primary endpoint by demonstrating that treatment with Lutathera was associated with a statistically significant and clinically meaningful 79% reduction in risk of disease progression or death versus treatment with a high dose (60 mg) of Octreotide LAR (hazard ratio 0.21, 95% Confidence Interval: 0.13-0.33; p<0.0001). the estimated pfs rate at month 20 was 65.2 95 confidence interval: 50.0-76.8 in the lutathera arm and 10.8 95 confidence interval: 3.5-23.0 in the control arm. median pfs was 8.4 months in the control arm and had not yet been reached in the lutathera arm. significant treatment benefits associated with lutathera were observed irrespective of stratification factors and prognostic factors. the response rate of 18 in the lutathera arm compared to 3 with octreotide is also notable given that response rates above 5 have not been observed in large randomized clinical trials investigating other systemic therapies in this population. although the trial has not reached the point at which median overall survival can be calculated interim analysis suggests an overall survival improvement.importantly lutathera when administered concomitantly with a renal-protective agent had low rates of grade three or four hematological toxicity and no evidence of nephrotoxicity observed over the study timeframe median follow-up time 14 months.>

See-"Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors"- Jonathan Strosberg, M.D., Ghassan El-Haddad, M.D., Edward Wolin, M.D., Andrew Hendifar, M.D., et.al., for the NETTER-1 Trial Investigators -N Engl J Med 2017; 376:125-135January 12, 2017DOI: 10.1056/NEJMoa1607427.

Comment; A rolling submission at the FDA has been completed.