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Navidea Biopharma Reports Top-Line Results from Interim Analysis of Lymphoseek Phase 3 Trial

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Navidea Biopharmaceuticals, Inc. (NYSE: NAVB), a biopharmaceutical company focused on the development and commercialization of precision diagnostic radiopharmaceuticals, today announced top-line results from the 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 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.

“These interim results are highly encouraging for this patient population who generally face extensive surgery to properly stage their cancer,” said Mark J. Pykett, V.M.D, Ph.D., President and CEO of Navidea. “This study is part of Navidea's strategy to expand Lymphoseek utilization into multiple cancer types and assist physicians in improving the accuracy and extent of cancer diagnosis for their patients. In light of the positive top-line results, and with consideration for the effect of these surgeries on patients, the study's Data Safety Monitoring Committee (DSMC) has recommended that we close the NEO3-06 trial early, a possibility the Company will assess as the full dataset becomes available. We expect to complete the full dataset and secondary analyses of this study, present them at major scientific meetings in the coming months, and evaluate the possibility of filing a Supplemental New Drug Application (sNDA) later this year.”

The primary endpoint for the NEO3-06 trial was based on the number of subjects with pathology-positive lymph nodes (that is, lymph nodes found to harbor cancer) 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. Results demonstrated that of these 39 patients, Lymphoseek accurately identified 38, 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. These findings indicate that Lymphoseek accurately identified SLNs in these trial subjects, and is likely to be predictive of overall node pathology status. FNR is the rate of occurrence of negative test results in subjects known to have the disease for which the individual is being tested. 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.

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