This is HUGE! Great news for patients who can now avoid radical and, many times, disfiguring surgery!
Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of precision diagnostic radiopharmaceuticals, 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.
According to a release, 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, 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."
"In the current standard of care with head and neck tumors, we may systematically remove as many as 60 or more lymph nodes within the neck during a formal dissection procedure, a large number due to the likelihood that patients may have hidden cancer in the lymphatic system," said Stephen Y. Lai, M.D., Ph.D., FACS, Associate Professor, Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center. "The use of sentinel lymph node biopsy for selected patients with head and neck cancers is in evolution. These combined interim data, along with our initial clinical experience with Lymphoseek, suggest a very high level of accuracy in the identification and mapping of SLNs that may significantly improve the precision and practicality of SLN mapping procedures, and provide precision staging that may help direct post-surgical treatment. We look forward to developing the full potential of this technology for the appropriate patients," added Dr. Lai.
"This clinical study is unique in that it compares the performance of Lymphoseek, a next-generation, receptor-targeted synthetic molecule to the pathological 'gold standard' multiple level dissection procedure in which a large portion of the head and neck lymph node tissue is removed," said Frederick Cope, Ph.D., F.A.C.N., Senior Vice President of Pharmaceutical Research and Drug Development at Navidea. "Achieving this degree of statistical significance versus the pathology of a multiple level dissection is testimony to the accuracy of Lymphoseek in identifying clinically significant lymph nodes through a less invasive diagnostic procedure."
More information:
www.navidea.com
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