Navidea Biopharmaceuticals announced top-line results from interim analysis of its Phase 3 clinical trial, NEO3-06, of Lymphoseek (technetium 99m tilmanocept) injection in patients with head and neck squamous cell carcinoma.
Results of the pre-planned interim analysis demonstrated that Lymphoseek met the primary efficacy endpoint of accurately identifying sentinel lymph nodes (SLNs) in subject with squamous cell carcinoma of the head or in the mouth, as compared to the removal of all lymph nodes during multiple level nodal dissection surgery of the head and neck. Lymphoseek is a novel, receptor-targeted, small-molecule radiopharmaceutical designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.
The study was a prospective, open-label, multicenter, within-patient study of Lymphoseek injection. It was designed to identify sentinel lymph nodes (SLNs) and determine the false negative rate (FNR) associated with Lymphoseek-identified SLNs relative to the pathological status of non-SLNs in head and neck and intraoral squamous cell carcinoma. FNR is the rate of occurrence of negative test results in subjects known to have the disease for which the individual is being tested. The primary endpoint for the NEO3-06 trial was based on the number of subjects with pathology-positive lymph nodes (lymph nodes found to harbor cancer) following a multiple level lymph node dissection. A minimum of 38 subjects whose lymph nodes contained pathology-confirmed disease was required. Thirty nine subjects out of over 80 subjects enrolled were determined to have pathology-positive lymph nodes.
Results demonstrated Lymphoseek accurately identified 38 out of 39, for an overall False Negative Rate (FNR) of 2.56%, which was statistically significant (P=0.0205) and met the statistical threshold for success of the primary endpoint. Moreover, multiple level nodal dissection of patients in the trial with cancer-positive lymph nodes led to an average removal of 38 lymph nodes per patient, whereas Lymphoseek on average led to the removal of approximately 4 lymph nodes, representing a substantial reduction in potential morbidity for patients with head and neck cancer undergoing sentinel lymph node biopsy.
Recently approved, Lymphoseek injection, a lymphatic mapping agent, is indicated for use with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma.
For more information call (800) 793-0079 or visit www.navidea.com.