Phase 3 Trial Update of Lymphoseek for Lymphatic Mapping in Melanoma

Navidea Biopharmaceuticals announced results from two Phase 3 clinical trials of Lymphoseek (technetium 99m tilmanocept) Injection in patients with melanoma of the skin, assessing the performance of Lymphoseek against the standard of care, vital blue dye (VBD), in lymphatic mapping.

The 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 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%).

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).

Melanoma-containing lymph nodes were detected in 34 (22.1%) patients; Lymphoseek identified all 45 melanoma-positive lymph nodes found in the 34 patients. Four of these 34 node-positive patients were detected exclusively by Lymphoseek. Blue dye detected 36 of the 45 melanoma-positive lymph nodes, but no melanoma-positive lymph nodes were detected exclusively by VBD.

Lymphoseek Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical used in lymphatic mapping procedures that are performed to help stage breast cancer and melanoma. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer, in patients with breast cancer or melanoma.

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