Abstract LB-416: Evaluation of phase 3 multicenter clinical data of receptor targeted (CD206) Tc99m-tilmanocept for sentinel node evaluation (ILM) in breast cancer and melanoma

Abstract

Abstract Background: Sentinel lymph node (SLN) mapping is widely used for staging clinically node-negative breast cancer and melanoma. [99mTc]tilmanocept is a new receptor-targeted (CD206) radiopharmaceutical designed for SLN mapping. The purpose of this review is to report the results of the Phase 3 clinical data designed to assess the concordance of [99mTc]tilmanocept with vital blue dye, considered the standard for identifying sentinel lymph nodes in these two malignancies. Methods: The Phase 3 program was a multicenter, prospective, open label, evaluation of [99mTc]tilmanocept in patientswith clinically localized melanoma or breast cancer. Within the Intent-to-treat population, [99mTc]tilmanocept and vital blue dye were administered to patients and standard SLN mapping was performed, during which all identified radioactive and/or blue-stained lymph nodes were excised and histologically examined. The primary endpoint was concordance of [99mTc]tilmanocept with vital blue dye. The patient concordance rate was defined as the percentage of patients for whom all nodes detected by blue dye were also detected by [99mTc]tilmanocept. Results: At least one blue-stained lymph node was exhibited by 91% patients and 98.0% had at least one “hot” node. The concordance of [99mTc]tilmanocept with vital blue dye was statistically significant with ∼98% concordant. Of the melanoma patients, ∼97% were concordant; and within the breast cancer patients, ∼99% were concordant. In contrast, vital blue dye had a concordance rate with [99mTc]tilmanocept of <55%. No severe adverse events were related to the administration of [99mTc]tilmanocept. Conclusions: [99mTc]Tilmanocept was well tolerated and effectively identifies sentinel nodes with a statistically significant degree of concordance to blue dye in either breast cancer or melanoma surgery. Additional outcomes will be presented. (Also refer to ClinicalTrials.gov, key word, tilmanocept) Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 102nd Annual Meeting of the American Association for Cancer Research; 2011 Apr 2-6; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2011;71(8 Suppl):Abstract nr LB-416. doi:10.1158/1538-7445.AM2011-LB-416