Clinical Trial Results

LUTATHERA® (Lutetium (177Lu) oxodotreotide)
Clinical Study

NETTER-1

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Clinical Study Results

GBq, gigabecquerels; IM, intramuscular; IV, intravenous.
 
CI, confidence interval; HR, hazard ratio.
 
 
CI, confidence interval; ENETS, European Neuroendocrine Tumor Society; LAR, long-acting release; ULN upper limits of normal.
 
 
 

*Includes Foregut, Midgut and Hindgut; **Foregut NETs other than bronchial and pancreatic
CI, confidence interval; CR, complete response; GEP-NET, gastroenteropancreatic neuroendocrine tumour; PR, partial response; SD, stable disease; ORR, objective response (CR+PR); DoR, duration of response.

*Includes Foregut, Midgut and Hindgut; **Foregut NETs other than bronchial and pancreatic
CI, confidence interval; PFS, progression-free survival; OS, overall survival.

 
 
 
 

CI, confidence interval.

References: 1. Strosberg J, El-Haddad G, Wolin E et al. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. New Engl J Med. 2017;376(2): 127–135. 2. LUTATHERA® Summary of Product Characteristics. January 2021. Available at: https://www.ema.europa.eu/en/documents/product-information/lutathera-epar-product-information_en.pdf Accessed April 2021. 3. Brabander, T., van der Zwan, W.A., Teunissen, J.J.M., Kam, B.L.R., Feelders, R.A., de Herder, W.W., et al. (2017). Long-Term Efficacy, Survival, and Safety of [(177)Lu-DOTA(0),Tyr(3)]octreotate in Patients with Gastroenteropancreatic and Bronchial Neuroendocrine Tumors. Clinical cancer research: an official journal of the American Association for Cancer Research. 23 (16). p.pp. 4617–4624. 4. Strosberg J, El-Haddad G, Wolin E et al. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. New Engl J Med. 2017;376(2): 127–135. (Suppl Appendix) 5. Khan, S., Krenning, E.P., van Essen, M., Kam, B.L., Teunissen, J.J. and Kwekkeboom, D.J. (2011). Quality of life in 265 patients with gastroenteropancreatic or bronchial neuroendocrine tumors treated with [177Lu-DOTA0,Tyr3]octreotate. Journal of nuclear medicine: official publication, Society of Nuclear Medicine. 52 (9). p.pp. 1361–8. 6. Strosberg et al. (2018). Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With 177Lu-Dotatate in the Phase III NETTER-1 Trial. J Clin Oncol 36, Sept 2018. 7. Singh S, Granberg D, Wolin E et al. Patient-Reported Burden of a Neuroendocrine Tumor (NET) Diagnosis: Results From the First Global Survey of Patients With NETs. J Glob Oncol. 2017;3(1): 43–53.