Advanced Accelerator Applications announces Phase III positive results for Lutathera (177Lu-DOTATATE) to treat neuroendocrine tumours

Advanced Accelerator Applications announced today at ECC 2015 that the pivotal Phase III NETTER-1 study for Lutathera (¹⁷⁷Lu-DOTATATE) met its primary endpoint of assessing progression-free survival (PFS), demonstrating that Lutathera significantly improved PFS when compared with Sandostatin LAR 60mg (octreotide LAR) in patients with advanced midgut neuroendocrine tumors (NETs). The NETTER-1 study met its primary endpoint by demonstrating that treatment with Lutathera was associated with a statistically significant and clinically meaningful risk reduction of 79% of disease progression or death versus a treatment with a double dose of Octreotide LAR (hazard ratio 0.21, 95% CI: 0.13-0.34; p<0.0001). The median PFS in the Lutathera arm was not yet reached, whilst the median PFS in the Octreotide LAR 60 mg arm was 8.4 months. The adverse events observed on Lutathera in NETTER-1 are consistent with the results of a previous Phase I-II study, with Lutathera demonstrating a favourable safety profile.

Comment: Advanced Accelerator Applications SA expects to start filing a rolling US NDA submission later this year 2015, and file a European marketing application in 2016 for its lead radiotherapeutic, Lutathera, to treat advanced mid-gut neuroendocrine tumours (NETs).