Phase 3 Trial Update of Lymphoseek for Lymph Node Mapping in Head and Neck Squamous Cell Carcinoma
Navidea Biopharmaceuticals announced data from its Phase 3 clinical study investigating 99m-Tc-Tilmanocept (Lymphoseek) in Sentinel Lymph Node (SLN) mapping in patients with head and neck squamous cell carcinoma (HNSCC).
The ongoing trial (NEO3-06; NCT00911326) is a multicenter, open-label, non-randomized, single arm, within-group trial of Lymphoseek for the detection of tumor-draining Sentinel Lymph Nodes in subjects with known cutaneous or mucosal squamous cell cancers of the head and neck. All subjects received a single dose of Lymphoseek. The presented data represent the findings from nine subjects who were injected, underwent surgery, and completed a 30-day follow up. Most subjects were injected on the day prior to their surgical procedure. In the trial, all subjects received the standard treatment of a full regional nodal dissection and the results of Lymphoseek-identified nodes were compared to pathology-positive nodes obtained from the full regional nodal dissection. In the nine subjects reported on, a total of 360 nodes were excised (22-55 non-SLNs identified per patient, median 39, average 40). The data show preoperative imaging with Lymphoseek provided accurate correlation of lymphatic drainage to tumor-involved anatomic regions and nodes, including SLNs contralateral to (opposite) the primary tumor. The 0% false negative rate in this small initial cohort indicates that Lymphoseek accurately identifies those nodes with the highest probability of accurately reflecting the status of regional/cervical metastases (ie, SLNs).
Lymphoseek is a proprietary radioactive diagnostic tracing agent developed for use in connection with gamma detection devices in ILM.
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