AAA reaches halfway recruitment milestone of cancer patients in Lutathera® Pivotal Phase III trial


Advanced Accelerator Applications has reached the 100-patient (halfway) milestone for the NETTER-1 study, an international Phase III clinical trial evaluating the effect of Lutathera® in patients with inoperable progressive midgut carcinoid tumors. The primary endpoint of the trial is the assessment of Progression-Free Survival, with secondary endpoints including Safety, Objective Response Rate, Time to Tumor Progression, Overall Survival and Quality of Life. 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 camera, with no additional cost. Phase II results 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 pre-marketing sales in eight European countries.