Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced results of a three-year, voluntary follow-up study of Lymphoseek ® (technetium Tc 99m tilmanocept) Injection conducted in patients who participated in a Phase 3 clinical trial (NEO3-05) of the product. The primary objective of the follow-up study was to determine the regional (i.e., draining lymph node basin) recurrence-free rate (RRFR) after sentinel lymph node biopsy with Lymphoseek. Results of the follow-up study indicated that in patients who were confirmed to be node-negative (N0) after sentinel lymph node biopsy (n=88; 49 breast cancer, 39 melanoma) the RRFR was 98.8% (100% in breast cancer; 97.4% in melanoma) and the disease-specific survival rate (DSSR) was 98.6% (97.8% in breast cancer; 100% in melanoma) at three years. The results, presented by Stephen P. Povoski, MD, of The Ohio State University Wexner Medical Center, will also be highlighted in a Grand Rounds presentation as one of several Lymphoseek presentations at SSO 2014, the 67 th Society of Surgical Oncology Annual Cancer Symposium, in Phoenix, Arizona. Lymphoseek is a novel, receptor-targeted, small-molecule radiopharmaceutical approved by the U.S. Food and Drug Administration for use in lymphatic mapping to assist in the localization of lymph nodes draining primary tumor in patients with breast cancer or melanoma
Findings from the Lymphoseek follow-up study compare favorably with outcomes from previously reported data from other studies. A study reported in the New England Journal of Medicine which evaluated the use of sentinel node biopsy or nodal observation node-negative (N0) melanoma patients 1 showed a DSSR at three years of 90.1%. In another study published in Lancet Oncology 2, node-negative (N0) breast cancer patients had an estimated disease-free survival rate at five years of 88.6%.
“Sentinel lymph node biopsy is well-established as an appropriate alternative to full lymph node dissection in node-negative, early-stage breast cancer and melanoma patients, and it can spare patients of the resultant morbidities associated with full lymph node dissection,” said Dr. Povoski. ”This three-year follow-up analysis was performed to assess outcomes associated with Lymphoseek-guided sentinel lymph node removal. Our findings support the contention that Lymphoseek, which has previously been shown to accurately identify tumor-draining sentinel lymph nodes in both early-stage breast cancer and melanoma patients, results in a very high detection rate, with patient outcome at three years of follow up demonstrating a very low recurrence rate and a high survival rate.”