Navidea Biopharmaceuticals, Inc. (NEOP, NAVB) announced top-line results from the interim analysis of its Phase 3 trial, NEO3-06, of Lymphoseek Injection in patients with head and neck squamous cell carcinoma. Results of the pre-planned interim analysis showed that Lymphoseek met the primary efficacy endpoint of accurately identifying sentinel lymph nodes in subjects 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.
Multiple level nodal dissection surgery is considered the "gold standard" to determine the presence and extent of cancer spread in lymph nodes of patients with head and neck squamous cell carcinoma. Lymphoseek was approved by the U.S. Food and Drug Administration in March, 2013 for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma.
The primary endpoint of the NEO3-06 study was based on the number of subjects with pathology-positive lymph nodes following a multiple level lymph node dissection and required a minimum of 38 subjects whose lymph nodes contained pathology-confirmed disease. Of the over 80 subjects enrolled in the NEO3-06 trial, 39 subjects were determined to have pathology-positive lymph nodes. The study results demonstrated that of these 39 patients, Lymphoseek accurately identified 38, for an overall False Negative Rate of 2.56%, which was statistically significant and met the statistical threshold for success of the primary endpoint.
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