Norgine BV has presented data from a Phase III study showing that Lymphoseek® (99mTc-tilmanocept) used with sentinel lymph node biopsy, could be an alternative to the current standard of care in oral cavity squamous cell carcinoma.
Sentinel lymph node biopsy is a simple procedure to remove and examine the first nodes where cancer cells may be present. These data were presented at the European Association of Nuclear Medicine (EANM) 2016, Spain.2
Lymphoseek® is highly predictive in the neck of patients with early oral cancer who had no clinical lymph node involvement. The data further demonstrate that if elective neck dissection had been used without sentinel lymph node biopsy, a cancer positive contralateral node may have been missed in 7.2% of the studied patients. In a small number of cases this was the only cancer positive lymph node.1
Lymphoseek® was well tolerated by the studied population.2
In major European markets**, there were 76,917 new cases of head and neck cancer diagnosed in 2014.3
Lymphoseek® 50 microgram kit for radiopharmaceutical preparation is approved in Europe for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity. External imaging and intraoperative evaluation may be performed using a gamma detection device.4
Dr Alastair Benbow, Chief Development & Medical Officer, Norgine commented: “Data show the use of lymphoseek® in sentinel lymph node biopsy for early oral cancer may provide a benefit to patients. 6 Currently, up to 70-80% of patients with early oral cancer receive elective neck dissection that may be potentially avoidable. This invasive procedure can result in further complications, morbidity and have a significant impact on patient lives.5 This new data demonstrates that if elective neck dissection had been used without sentinel lymph node biopsy, a cancer positive contralateral node may have been missed in 7.2% of the studied patients.”1
*For original analysis see A. Agrawal et al. 2015 6
**Countries included were France, Germany, Italy, Spain and the United Kingdom.
1 Bilateral and contralateral sentinel node identification with 99mTc-tilmanocept (LYMPHOSEEK®) in oral cavity squamous cell carcinoma patients. Abstract OP124. EANM 2016
2 Sentinel lymph node biopsy using 99mTc-tilmanocept (LYMPHOSEEK®) in patients with oral cavity squamous cell carcinoma: Safety results from Phase III clinical trial. Abstract OP123. EANM 2016
3 Incidence of head and neck cancer in Europe. Norgine data on file. DOF-LYMPH-002.
4 European Medicines Agency LYMPHOSEEK®approval. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002085/human_med_001827.jsp&mid=WC0b01ac058001d124. Accessed 22 September 2016
5 Civantos FJ, et al. J Clin Oncol 2010; 28(8): 1395-1400
6 Agrawal A, et al. Ann Surg Oncol 2015; 22(11): 3708-3715.