The results indicated that Lymphoseek sensitivity for sentinel lymph node mapping was consistent across the tumor type studies, regardless of whether surgery was conducted on the same day as, or on the day after injection of Lymphoseek.
Additionally, for patients with head and neck cancer, Lymphoseek demonstrated a low false negative rate (FNR) of 2.6% (4.6% for same day injection before surgery and 0.0% FNR in patients injected the day prior to surgery). Results from the study comprise part of an sNDA filing for Lymphoseek which is under review by the U.S. Food and Drug Administration.
"Flexibility and the ability to predictably image and schedule lymphatic mapping procedures either the day before or on the same day of surgery enable efficient and economical utilization of staff and healthcare resources," said James O’Donnell, M.D., Division Chief, Nuclear Medicine, UH Case Medical Center, Cleveland, Ohio.
"The convenience of receptor-targeted imaging agents such as Lymphoseek, which can provide diagnostic accuracy, rapid injection site clearance and predictable lymph node uptake, facilitate lymphatic mapping and informed diagnostic evaluation by clinicians for patients who may have breast cancer, melanoma or head and neck cancer."
"These results clearly demonstrate the clinical adaptability and utility of Lymphoseek in sentinel lymph node lymphatic mapping to reliably identify tumor-draining lymph nodes that may be at high risk of harboring cancer in patients with breast cancer, melanoma or head and neck squamous cell carcinoma," said Cornelia Reininger, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Navidea.
"Our sNDA for Lymphoseek use in sentinel node biopsy in patients with head and neck cancer, based in part on this study, is in Priority Review with the FDA with an approaching PDUFA date of June 16, 2014. Results from this study are also included in a second sNDA for Lymphoseek label expansion currently in review with the FDA, which is designed to support more flexible utilization of Lymphoseek in lymphatic mapping and lymphoscintigraphy imaging. These applications reflect Navidea’s commitment to expanding usage and indications for Lymphoseek and our belief that the product can provide a flexible, reliable and cost-effective solution for lymphatic mapping across a wide range of tumor types."
The study evaluated Lymphoseek sensitivity in 384 evaluable patients from three pivotal Phase 3 clinical studies: two Phase 3 studies in patients with breast cancer and melanoma (melanoma, n=153; breast cancer, n=148) and one Phase 3 study in patients with head and neck squamous cell carcinoma (n=83).
Patients were injected before surgery, imaged, and then surgery was conducted up to 30 hours post-injection. Results based on sensitivity for day-of-injection or day-after-injection were compared. Meta-analysis results across tumor types (n=100 pathology-positive patients) indicated per patient sensitivity for Lymphoseek in identifying pathology-positive subjects.
Sensitivity for Lymphoseek was 99% in same day injection procedures, and 99% in surgery procedures performed the day after injection. In addition, the FNR for patients with head and neck squamous cell carcinoma was 4.6% (95% CI: 0.1%-22.8%) for same day injection (n=40) and 0.000 (95% CI: 0%-20.6%) for patients who had surgery on the day after injection (n=42). The data were presented by Bonnie Abbruzzese, Director, Clinical Research, MS, RD, CCRA, Navidea Biopharmaceuticals, at the 2014 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in St. Louis, Mo.