Lymphoseek tilmanocept: Additional Phase III data
Top-line data from the open-label, U.S. Phase III NEO3-06 trial in over 80 patients with SCCHN showed that preoperative imaging with a single injection of Lymphoseek met the primary endpoint of accurately identifying sentinel lymph nodes as compared to the removal of all lymph nodes during multiple level nodal dissection surgery of the head and neck. Specifically, of the 39 patients determined to have pathology-positive lymph nodes, Lymphoseek accurately identified 38 sentinel lymph nodes for an overall false negative rate of 2.56% (p=0.0205). Patients were injected with a single dose of Lymphoseek prior to undergoing full regional nodal dissection. The results of Lymphoseek-identified nodes were then compared to pathology-positive nodes obtained from the dissection. ...