The efficacy and safety of Lymphoseek were assessed in three open-label, multicenter, single arm trials of adult patients with melanoma, breast cancer, or squamous cell carcinoma (SCC) of the oral cavity, skin, and lip (Studies 1, 2, and 3) and one open-label, multicenter, single arm trial of pediatric patients with melanoma, rhabdomyosarcoma, or other solid tumor (Study 4). Prior to the lymph node mapping and sentinel lymph node biopsy procedures, patients had no known regional nodal or metastatic disease by standard clinical staging criteria.

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    In Studies 1 and 2, Lymphoseek was evaluated in adult patients with breast cancer and melanoma. Diagnostic efficacy for lymphatic mapping was determined by the number of histology-confirmed lymph nodes detected by Lymphoseek and/or the blue dye comparator. Lymphoseek was injected into patients at least 15 minutes prior to initiating lymphatic mapping procedures, and preoperative scintigraphic imaging was performed in 91% of patients. Separately, blue dye was injected shortly prior to initiation of the surgery. Lymphatic mapping was performed intraoperatively using a handheld gamma detection probe followed by excision of lymph nodes identified by Lymphoseek, blue dye, or the surgeon’s visual and palpation examination. The resected lymph nodes were evaluated by histopathology. Lymphoseek localization rate in pathology-positive lymph nodes was also determined.

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    In Study 1, of 179 patients who received Lymphoseek, 94 (53%) had known or suspected breast cancer and 85 (47%) had known or suspected melanoma. The median age was 59 years (range 20 to 90 years) and most (72%) were female.
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    In Study 2, of 153 patients who received Lymphoseek, 77 (50%) had known or suspected breast cancer and 76 (50%) had known or suspected melanoma. The median age was 61 years (range 26 to 88 years) and most (68%) were female.
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    In Study 3, Lymphoseek was evaluated in adult patients primarily with SCC of the oral cavity (T1-T4a, N0, M0). Diagnostic efficacy was determined by the patient level false negative rate of sentinel lymph node detection by Lymphoseek as confirmed by pathologic assessment of all lymph nodes removed during planned elective neck dissection (END). Lymphoseek was administered at least 15 minutes prior to the scheduled surgery and preoperative scintigraphic imaging was performed in all patients. Lymphatic mapping was performed intraoperatively using a handheld gamma counter followed by excision of sentinel lymph nodes identified by Lymphoseek. Additional lymph nodes were removed during the END based upon tumor location and surgical practice. All resected lymph nodes (sentinel and non-sentinel) were evaluated for histopathology at the local site. Lymphoseek-identified nodes determined negative for cancer were further evaluated by a central pathology laboratory using additional step sectioning and cytokeratin staining.

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    Of the 85 patients who received Lymphoseek, 79 (93%) had intraoral SCC and 6 (7%) had cutaneous SCC. The median age was 59 years (range 23 to 87 years) and most (75%) were male.
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    In Study 4, Lymphoseek was evaluated in pediatric patients with melanoma, rhabdomyosarcoma, or other solid tumor. Safety and diagnostic efficacy for lymphatic mapping were determined. Lymphoseek was injected into patients at least 15 minutes prior to initiating lymphatic mapping procedures, and preoperative scintigraphic imaging was performed in 91% of patients. Blue dye was injected prior to initiation of the surgery in 21 patients. Lymphatic mapping was performed intraoperatively using a handheld gamma detection probe followed by excision of lymph nodes identified by Lymphoseek, blue dye (when used adjunctively), or the surgeon’s visual and palpation examination. The resected lymph nodes were evaluated by histopathology. Lymphoseek localization rate in pathology-positive lymph nodes was also determined.

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    Of the 23 patients who received Lymphoseek, 5 (22%) had melanoma, 4 (17%) had rhabdomyosarcoma, 12 (52%) had non-rhabdomyosarcoma soft tissue sarcomas, and 2 (9%) had atypical Spitz nevi. The mean age was 11.6 years (range 1.7 to 17 years) and most (65%) were female.