SAINT-GENIS-POUILLY, France, March 06, 2017 (GLOBE NEWSWIRE) -- Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (“AAA” or the “Company”), an international specialist in Molecular Nuclear Medicine (MNM), today announced that quality of life findings from the pivotal NETTER-1 Phase III study investigating the treatment of Lutetium Lu 177 Dotatate in patients with somatostatin receptor positive midgut neuroendocrine tumors (midgut NETs) will be presented at the 14th Annual Conference of the European Neuroendocrine Tumor Society (ENETS), March 8-10 in Barcelona, Spain.
The details of the presentations are as follows:
Abstract # 1676: NETTER-1 Phase III Trial: Recent Findings on Quality of Life in Patients with Midgut Neuroendocrine Tumors
Speaker: Jonathan Strosberg, MD, Associate Professor, Section Head, Neuroendocrine Tumor Program at Moffitt Cancer Center
Session Title: Clinical Abstracts (4B)
Session Date: March 9, 2017
Session Time: 14:15-14:25 Central European Time
NETTER-1 is the first Phase III multi-center, randomized, controlled trial evaluating Lutetium Lu 177 Dotatate in patients with inoperable, progressive, somatostatin receptor positive midgut NETs. 229 patients with Grade 1-2 metastatic midgut NETs (both functioning and not functioning) were randomized to receive Lutetium Lu 177 Dotatate 7.4 GBq every 8 weeks (x4 administrations), plus best supportive care (Octreotide LAR 30 mg for symptom control) versus Octreotide LAR 60 mg every 4 weeks. The primary endpoint was Progression Free Survival (PFS) per RECIST 1.1 criteria, with tumor response assessment performed by an independent blinded reading center every 12 weeks. Secondary endpoints included objective response rate, overall survival, safety, and health-related quality of life. Analysis of NETTER-1 PFS results showed the number of patients having disease progression or death was 23 in the Lutetium Lu 177 Dotatate arm and 68 in the Octreotide LAR 60 mg arm. Thus, the NETTER-1 study met its primary endpoint by demonstrating that treatment with Lutetium Lu 177 Dotatate was associated with a statistically significant and clinically meaningful risk reduction of 79% of disease progression or death versus Octreotide LAR 60 mg (hazard ratio 0.21, 95% CI: 0.13-0.33; p<0.0001).
About Lutetium Lu 177 Dotatate (Lutathera®)
Lutetium Lu 177 Dotatate (Lutathera®) is an investigational, Lu-177-labeled somatostatin analog peptide currently in development for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. Lutetium Lu 177 Dotatate belongs to an emerging form of treatments called Peptide Receptor Radionuclide Therapy (PRRT), which involves targeting neuroendocrine tumors with radiolabeled somatostatin analog peptides. This novel, investigational compound has received orphan drug designation from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Currently, Lutetium Lu 177 Dotatate is administered on a compassionate use and named patient basis for the treatment of NETs and other tumors over-expressing somatostatin receptors in ten European countries and in the U.S. under an Expanded Access Program (EAP) for midgut NETs. New Drug Application and Marketing Authorization Application submissions to the FDA and EMA for Lutetium Lu 177 Dotatate are currently under review.
About Advanced Accelerator Applications
Advanced Accelerator Applications is an innovative radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicine products. AAA’s lead investigational therapeutic candidate, Lutetium Lu 177 Dotatate (Lutathera®), is a novel MNM compound that AAA is currently developing for the treatment of Neuroendocrine Tumors, a significant unmet medical need. Founded in 2002, AAA has its headquarters in Saint-Genis-Pouilly, France. AAA currently has 22 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and has 500 employees in 13 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium, Israel, U.S. and Canada). AAA reported sales of €88.6 million in 2015 (+27% vs. 2014) and sales of €81.3 million for the first 9 months of 2016 (+23% vs. 9 months 2015). AAA is listed on the Nasdaq Global Select Market under the ticker “AAAP”. For more information, please visit: www.adacap.com.
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