Advanced Accelerator Applications Reaches Halfway Recruitment Milestone of Cancer Patients in Lutathera® Pivotal Phase III Trial
Published: Oct 16, 2013
SAINT-GENIS-POUILLY, France, October 16, 2013 -- /PRNewswire/ --
Advanced Accelerator Applications (AAA), a fast growing international player in Molecular Nuclear Medicine (MNM), announced today that the 100-patient milestone has been reached for the NETTER-1 study, an international Phase III clinical trial evaluating the effect of Lutathera® in patients with inoperable progressive midgut carcinoid tumors. Lutathera® is the first theragnostic drug in MNM to enter phase III clinical development. Its efficacy can be imaged and evaluated at each of a total of four treatments via a SPECT (Single Photon Emission Computed Tomography) camera, with no additional cost.
Stefano Buono, Chief Executive Officer of AAA, commented: "Recruitment has really started to gain momentum as physicians increasingly recognize the potential of Lutathera®to help patients with this fatal disease. We expect results from the study to be published in 2015 and hope to obtain marketing authorization in H1 2017."
NETTER-1 is a Phase III, international, multi-center, randomized, comparator-controlled, parallel-group study evaluating the efficacy and safety of Lutathera® compared to Novartis' Sandostatin® LAR, in patients with inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumors. The primary endpoint of the trial is the assessment of Progression-Free Survival. Secondary endpoints include Safety, Objective Response Rate, Time to Tumor Progression, Overall Survival and Quality of Life.
The study will include 200 patients across 51 centers in nine different countries (Austria, Belgium, France, Germany, Italy, Portugal, Spain, UK and the US). The rate of recruitment has accelerated in both Europe and the US, with 68 additional patients consenting to take part in the study (26 in Europe and 42 in the US) in the past six months. As of today, 43 sites have been initiated (31 in Europe, 12 in US), and 23 of them are actively recruiting.
Phase II results of Lutathera® in patients with progressive midgut carcinoid showed Progression-Free Survival of over 45 months compared to the reported 14.6 months of Novartis' Sandostatin® LAR.
• Lutathera® is currently used on a named patient basis or compassionate use for pre-marketing sales in several European countries (Austria, Estonia, Finland, Greece, Portugal, Spain, Switzerland and the UK) when no alternative therapeutic option is available and under specific authorization.
About Advanced Accelerator Applications
Advanced Accelerator Applications (AAA) is a European pharmaceutical company founded in 2002 to develop innovative diagnostic and therapeutic products. AAA's main focus is in the field of Molecular Imaging and targeted, individualized therapy for the management of patients with serious conditions (Personalized Medicine). AAA currently has 16 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products and over 260 employees in 10 countries (France, Italy, Germany, Switzerland, Spain, Poland, Portugal, Israel, U.S., Canada). In 2012 AAA reported revenues of €44.6 million (+22.5% vs. 2011) and an EBITDA of €9.4 million (+59% vs. 2011). For more information please visit: http://www.adacap.com
Lutathera®, 177Lutetium-DOTA0-Tyr3-Octreotate, is a radiolabeled somatostatin analog that selectively targets somatostatin receptors which are over-expressed in some tumor types.
It acts like a Trojan horse, delivering 177Lu directly into the tumor cell. 177Lu is an instable particle that releases an electron, which, as in radiotherapy, is capable of killing the tumors by breaking the DNA of its cells. It also releases a gamma ray, which exits the body and enables physicians to image and evaluate the progress of the treatment via a SPECT (Single Photon Emission Computed Tomography) camera. Lutathera® is a true example of a theragnostic drug, since its efficacy can be evaluated and monitored using imaging at every therapeutic injection, without additional costs.
Lutathera® was developed by AAA's wholly-owned subsidiary, BioSynthema Inc, based in St Louis, Missouri, USA under a licence from Covidien. Lutathera® has orphan drug status in Europe, Switzerland and the USA.
A single Phase III protocol was submitted to both the FDA and EMA at the same time using a Parallel Scientific Advice procedure. Phase I/II results were based on an independent review of a large investigator-sponsored clinical study in over 600 patients affected by different Gastro Entero Pancreatic Neuro Endocrine Tumors (GEP-NETs) subtypes performed at the Erasmus Medical Centre, Rotterdam. Lutathera® was shown to extend patients' lives by between 3.5 and 6 years in comparison to current treatments, including chemotherapy. It was also shown to significantly improve quality of life.