Lymphoseek® Data Presented By Independent Investigators At 8th International Conference On Head And Neck Cancer

Highlights of the Presentations

• In an oral presentation, “Use of a Novel Receptor-targeted (CD206) Radiotracer, 99m-Tc-Tilmanocept, and SPECT/CT for Sentinel Lymph Node (SLN) Mapping in Head and Neck Squamous Cell Carcinoma (SSCa): Initial Report of Institutional Experience in an Ongoing Phase 3 Study (S146),” Dr. Anna Marcinow of The Ohio State University described the clinical experience with 99m-Tc-tilmanocept in 18 patients. As stated in the abstract, “The data yielded a FNR of 0% and a negative predictive value of 100% using 99m-Tc-tilmanocept in conjunction with SLN mapping and biopsy in the identification of occult metastases.”
• In a second oral presentation titled, “99m-Tc-Tilmanocept-Identified Sentinel Lymph Nodes Relative to the Pathological Status of Non-Sentinel Lymph Nodes in an Elective Neck Dissection in Cutaneous and Intraoral Head and Neck Squamous Cell Carcinoma: A Single Institutional Experience (S150),” Dr. Stephen Y. Lai, of the University of Texas MD Anderson Cancer Center, described the experience with 99m-Tc-tilmanocept. As stated in the abstract, “Nineteen patients have been enrolled at MD Anderson, and fifteen patients have completed a 30-day follow up at this site which is actively enrolling patients. As all intraoperative 99m-Tc-tilmanocept findings were predictive of the END findings and lead to correct patient staging, the FNR per patients evaluated at this site is 0%. There have been no significant adverse events related to the use of 99m-Tc-tilmanocept.”
• The clinical experience at the University of Miami was presented in a poster by its author, Dr. Francisco Civantos, titled “Clinical Experience at the University of Miami in a Phase 3 Trial Using Receptor Targeted 99m-Tc-Tilmanocept to Identify and Evaluate the Pathological Status of Sentinel Lymph Nodes (SLNs) vs. Elective Neck Dissection (END) for Patients with Intraoral Squamous Cell Carcinoma.” As stated in the abstract, “At this actively enrolling site, eleven patients have been enrolled. Six patients have undergone SLN mapping and surgery, and completed the study with a 30 day safety follow up. Results showed a 0% per patient FNR, indicating that 99m-Tc-tilmanocept accurately identified those nodes with the highest probability of containing tumor metastases. Additionally, in these patients a negative 99m-Tc-tilmanocept-identified pathology status was 100% predictive of the pathological status of the patient. There have been no significant adverse events related to the use of 99m-Tc-tilmanocept in these patients.”

The results presented at ICHNC are independent results from individual clinical sites participating in NEO3-06 that may or may not be consistent with the complete data that will be available when the trial is completed. The percentage agreement between nodes identified by Lymphoseek and pathology results from a complete neck dissection may decline upon analysis of the data from the completed trial.

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