AAA annonce des résultats positifs pour l’étude de phase III NETTER-1 évaluant Lutathera chez les patients atteints de tumeurs neuroendocrines avancées de l’intestin moyen

The detailed results of the study presented at the European Congress of Oncology in 2015 show that ECC Lutathera increases significantly PFS

SAINT-GENIS-POUILLY, FRANCE / ACCESSWIRE / September 27, 2015 / Advanced Accelerator Applications SA (AAA), an international company specializing in Molecular Nuclear Medicine (MNM), today announced that the clinical trial phase III pivotal NETTER-1 evaluating Lutathera (177 Lu-DOTATATE) met its primary endpoint, demonstrating a significant increase in progression-free survival for Lutathera versus Sandostatin LAR 60mg (Octreotide LAR) in patients with neuroendocrine tumors (NET) advanced the midgut.

Key points:

– Statistically significant increase in progression-free survival (PFS / PFS) with 4 administrations Lutathera 7.4 GBq every 8 weeks in patients with advanced neuroendocrine tumors of the midgut (p <0.0001, hazard ratio = 0.21; 95% CI: .13-.34).

– The median PFS in the Lutathera arm has not been reached while the median was 8.4 months in arm Octreotide LAR (60mg).

– The safety data generated in this study are consistent with the known safety profile of Lutathera.

The results were presented in the late-breaking abstract 6LBA “Lu-177-Dotatate Significantly Improves progression-free survival in patients with neuroendocrine tumors mid gut. Results of the Phase III trial NETTER-1” This abstract was presented today at the European Cancer Conference in Vienna during the Presidential Session II.

The NETTER-1 study met its primary endpoint, demonstrating that treatment with Lutathera is associated with a statistically and clinically significant 79% reduction in the risk of disease progression or death compared to treatment with a double Octreotide LAR dose (hazard ratio = 0.21, 95% CI 0.13 to 0.34; p <0.0001). The median PFS in the Lutathera arm has not been reached while the median duration of progression-free survival Octreotide LAR 60mg arm was 8.4 months. Adverse events observed with Lutathera in NETTER-1 study are consistent with the results of the previous phase I-II, Lutathera with a favorable safety profile.

“Netter-1 is the first multinational phase III study demonstrating major efficiency Lutathera in patients with advanced neuroendocrine tumors of the midgut,” said Stefano Buono, CEO of AAA. “We are very satisfied of the positive results of the study. We think Lutathera has the potential to bring a significant clinical benefit for patients and improve the management of this disease.”

Teacher. Philippe Ruszniewski, Gastroenterology Service of the Hospital Beaujon in Clichy and Dean of the Faculty of Medicine Paris Diderot (France), one of the investigators of the clinical study, commented: “The results of the study NETTER -1 demonstrated statistically and clinically significant improvement in PFS for patients Lutathera of advanced neuroendocrine tumors of ntestin means. This is the first time that a clinical Phase 3 study showed an increase PFS with PRRT in the treatment of entero-pancreatic gastrointestinal neuroendocrine tumors (NET-GEP). “

Results:

The recruitment was finalized in February 2015 with the objective 230 patients randomized (1: 1) across 36 sites in Europe and 15 in the United States. Upon statistical analysis, the number of disease progression or death was 23 confirmed centrally in Lutathera group and 67 in the group Octreotide LAR 60 mg. The median PFS has not yet reached for Lutathera up from 8.4 months with 60 mg Octreotide LAR [95% CI: 5.8 to 11.0 months], p <0.0001, with a chance ratio of 0.21 [95% CI: 0.13 to 0.34]. All data available on évaluabes tumor responses (n = 201), 19 patients Lutathera group (19%) achieved a complete or partial response (CR + PR) against 3 patients (3%) in the group Octreotide LAR 60 mg (p <0.0004). Although data on overall survival (OS) are not mature enough for a definitive analysis, the number of deaths was 13 in Lutathera group and 22 in the Octreotide LAR 60 mg group (p <0.0186 at Interim analysis) suggesting an improvement in overall survival.

The Phase III NETTER-1 study showed a statistically and clinically significant increase in PFS and objective response rate (ORR) and also suggests a survival benefit for patients with advanced neuroendocrine tumors of the midgut treated with Lutathera.

Adverse events observed with Lutathera in NETTER-1 study were generally consistent with the known side effects profile.

All main secondary endpoints are currently being analyzed.

About Lutathera:

Lutathera (or 177 Lu-DOTATATE) is a peptide analogue of somatostatin labeled Lutetium-177, or Lu-177, currently under development for the treatment of entero-pancreatic gastrointestinal neuroendocrine tumors (NET-GEP). This new drug has received the orphan drug designation from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in the USA. Lutathera also received in April 2015, the Fast Track designation (accelerated procedure) from the FDA for the treatment of neuroendocrine tumors of the midgut inoperable, up. Octroit FDA Fast Track designation (accelerated procedure) to product candidates for the treatment of serious diseases which respond to a therapeutic vacuum to facilitate their development and to accelerate their examination. In addition, the Lutathera is now authorized compassionate use in ten European countries where no alternative therapy available and with special permission.

Lutathera part of an emerging family of treatments called peptide receptor radionuclide therapy (PRRT) targeting carcinoid tumors with somatostatin peptide analogues radiolabeled. Currently in the late clinical phase III pivotal study with Netter-1, Lutathera is the most advanced candidate in development PRRT.

About Netter-1:

Netter-1 is the first phase III, multicenter, randomized, controlled by a standard treatment to assess 177 Lu-DOTA0-Tyr3-octreotate (Lutathera) in patients with neuroendocrine tumors of the midgut, inoperable, up overexpressing somatostatin receptors. 230 patients with metastatic neuroendocrine tumors of the midgut grade 1-2, functional or nonfunctional, were randomized to receive four administrations of an activity of 7.4 GBq each every 8 weeks against 60 mg octreotide LAR all 4 weeks vs. Octreotide LAR 60mg every 4 weeks. The primary endpoint was PFS based on RECIST 1.1 criteria with an objective evaluation of tumors by an independent reading center every 12 weeks. Secondary endpoints included objective response rate, overall survival, toxicity and quality of life.

About neuroendocrine tumors (NET):

Neuroendocrine tumors (NETs) are a group of tumors originating from neuroendocrine cells of the body. NETs can remain “silent” clinically for years, delaying diagnosis from a large number of patients. These cancers are rare but represent the second type of gastrointestinal cancer the most common and their impact is increasing.

We believe that the impact of the midgut NET is now around 47,300 patients in total in the United States and European Union.

NETs are classified as orphan diseases by European and US authorities, meaning that they affect a relatively small population of people in the countries concerned. In the US, orphan drugs are defined as drugs used to treat diseases or conditions that affect fewer than 200,000 people on their territory. In the EU, orphan drugs are defined as drugs that treat diseases or conditions affecting fewer than five people per 10,000.

About Advanced Accelerator Applications:

Advanced Accelerator Applications (AAA), radiopharmaceutical group founded in 2002, has extensive experience in the development of innovative products and applications for therapeutic and diagnostic, and particularly focuses on the fields of molecular imaging and personalized medicine. To date, AAA has 17 production laboratories and R & D and employs over 380 employees in 11 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, Israel, USA and Canada) . In 2014, sales of AAA amounted to € 69.9 million euros (+ 29.8% vs. 2013). Sales for the first six months of 2015 reached € 43 million (+ 29.5% vs. H1 2014). For more information about AAA, please visit www.adacap.com.

Discharge:

This press release may contain forward-looking statements. All statements, other than statements of historical fact contained in this press release, including statements regarding the company’s strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipates”, “believes”, “estimates”, “expects”, “intends”, “may”, “plans”, “expects”, “plans”, “target”, ” potential “,” will “,” would “,” could “,” should “,” continue “and similar expressions are intended to identify forward-looking statements, although some forward-looking statements do not contain these specific words. Forward-looking statements reflect the current expectations of the Company regarding future events. These forward-looking statements involve risks and uncertainties and other factors that could cause actual results to significantly differ from future results, performance or achievements expressed or implicated by such statements. These factors include, but are not limited to, changing market conditions, the successful completion and timely completion of clinical studies, the approval of the EMA, the FDA and other regulatory approvals for our products in development , the establishment of corporate alliances, the impact of competition in terms of products and pricing, new product development and uncertainties related to the regulatory approval process or the ability to obtain pharmaceutical products in quantity sufficient or acceptable standards for regulatory health authorities to complete clinical trials or to meet commercial demand. AAA is providing the information in this press release to this date and is not required to update the forward-looking statements as a result of new information, future events or otherwise, unless the laws applicable securities require.

Contacts:

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Jordan Silverstein
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SOURCE: Advanced Accelerator Applications SA

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