“Lymphoseek was specifically designed to provide actionable information for clinicians who perform lymphatic mapping procedures, and we believe that the data reported in this publication demonstrate its utility and safety in identifying tumor-draining lymph nodes,” said Mark Pykett, Ph.D., President and CEO of Navidea. “These data from melanoma patients, as well as data from our Phase 3 trials in breast cancer, comprise part of our NDA registration package for Lymphoseek with the FDA, and we are confident that Lymphoseek may hold significant promise for patients undergoing lymphatic mapping procedures.”
Completed Lymphoseek Phase 3 Clinical Trials in Melanoma
Two Phase 3 non-randomized trials (NE03-05, NE03-09) were conducted in patients with cutaneous melanoma undergoing lymphatic mapping. The primary endpoint was the rate of agreement (concordance) between Lymphoseek and VBD, which was defined as the proportion of lymph nodes identified by VBD that were also identified by Lymphoseek. A pre-specified minimum rate of agreement of 90% had been established in the trials’ statistical plan. In the trials, a total of 154 patients with melanoma from 15 centers received Lymphoseek followed by VBD and then underwent sentinel lymph node mapping. Lymph nodes that demonstrated Lymphoseek uptake and/or the presence of blue dye were removed and examined for the presence of tumor. Of the 235 blue-dyed lymph nodes removed from the 154 patients, 232 (98.7%) demonstrated Lymphoseek uptake (p<0.001).
In assessing reverse concordance (the proportion of blue-dyed nodes relative to all nodes with Lymphoseek uptake) according to the protocol, Lymphoseek detected 364 lymph nodes. Of these nodes, VBD detected 232 (63.7%).Lymph node identification The performance of Lymphoseek in intraoperative lymph node identification was also assessed. Of the 154 patients injected with both Lymphoseek and VBD who underwent surgical removal of the lymph nodes, 150 patients (97.4%) had at least one radioactive node, due to Lymphoseek uptake, and 138 patients (89.6%) had at least one blue node. This difference was statistically significant (p<0.002).