Advanced Accelerator Applications announced today that the pivotal Phase 3 NETTER-1 clinical study investigating the treatment of Lutathera in patients with inoperable, progressive, somatostatin receptor positive midgut Neuro Endocrine Tumors (midgut NETs) has met its primary endpoint, demonstrating a statistically significant and clinically meaningful increase in progression-free survival for Lutathera versus a double dose of Sandostatin LAR. The pivotal Phase 3 study results will be presented for the first time on Sunday, September 27, 2015, at the European Cancer Congress (ECC) 2015 in Vienna, Austria.
The late-breaking abstract was chosen to be presented in one of three Presidential sessions, and has also been selected to be featured as part of the official media program at ECC 2015.
Other important news announced by AAA today is that the U.S. Food and Drug Administration (FDA) has granted Priority Review to AAA’s New Drug Application (NDA) for SomaKit-TATE, Lutathera’s companion PET (Positron Emission Tomography) Diagnostic.
Stefano Buono, Chief Executive Officer of AAA, commented: “We believe that Somakit and Lutathera, if approved, have the potential to provide significant improvement in the treatment of GEP-NET patients.”