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Neoprobe Unveils Phase 3 Data Evaluating Lymphoseek

Concordant detection rate of lymph nodes in breast cancer patients was 96%

Neoprobe’ researchers, who participated in the breast cancer arm of a Phase 3 clinical evaluation of Lymphoseek, have presented data from their clinical experience at the International San Antonio Breast Cancer Symposium.

The Phase 3 study was conducted in patients with either breast cancer or melanoma. The presentation provided information on the breast cancer portion of the trial. Earlier this year, Neoprobe announced that the trial evaluated 130 procedure-compliant patients. The breast cancer arm of the trial contributed 60 patients.

The company said that the Phase 3 trial was designed to determine the accuracy of Lymphoseek to identify lymphatic tissue as compared to a commonly used vital blue dye. The primary objective of the trial was to obtain at least 203 lymph nodes identified with the vital blue dyes and to statistically demonstrate that 94% of those nodes were identified with Lymphoseek.

Reportedly, the procedure-compliant patients contributed 215 vital blue dye positive lymph nodes and Lymphoseek identified 210 of those nodes for a success rate of 97%. In addition, Lymphoseek identified 85 lymph nodes that were missed by the vital blue dyes. Of those Lymphoseek-only positive nodes, 18% were found to contain tumor.

Results of the breast cancer portion of the Phase 3 trial showed the overall results. The breast cancer patients provided 97 vital blue dye positive lymph nodes and 93 of those nodes were positive for Lymphoseek. The concordant detection rate of lymph nodes in breast cancer patients was 96%.

In addition, Lymphoseek identified 49 lymph nodes in the breast cancer patients that were missed by the vital blue dyes. Of those Lymphoseek-only positive nodes, 10% were found by pathology to contain tumor. No drug-related adverse events were reported that were attributed to Lymphoseek.

Frederick Cope, vice president of pharmaceutical research and clinical development at Neoprobe, said: “We are very pleased by the positive audited data of the Phase 3 clinical trial for Lymphoseek in both breast cancer and melanoma patients. The results of the Phase 3 trial have been provided to FDA and we believe if Lymphoseek is ultimately cleared for marketing that it will provide meaningful improvement in the treatment of cancer patients.”