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touchFEATURE Efficacy and safety results from the Phase 3 NETTER-1 trial with LUTATHERA® (lutetium (177Lu) oxodotreotide)
Discover key efficacy and safety results from an international Phase 3 clinical trial of LUTATHERA® in patients with midgut neuroendocrine tumours (NET).1
LUTATHERA®: Radioligand therapy for patients with gastroenteropancreatic neuroendocrine tumours (GEP-NET)
Dr Isabel Sevilla, Virgen de la Victoria University Hospital, Málaga, Spain, explains the rationale for targeted radioligand therapy in GEP-NET and specific mechanism of action of LUTATHERA®.5
1/5 Next ChapterProgression-free survival: primary analysis of the Phase 3 NETTER-1 clinical trial
Progression-free survival was the primary endpoint of the NETTER-1 study.1 Dr Alejandro GarcÃa, Vall d’Hebron University Hospital, Barcelona, Spain, discusses the significant reduction of risk of disease progression or death observed with LUTATHERA® plus octreotide LAR 30mg vs. active control (octreotide LAR 60mg*).1
2/5 Next ChapterOverall survival with LUTATHERA®: final analysis from the NETTER-1 clinical trial
Overall survival (OS) was a key secondary endpoint in the Phase 3 NETTER-1 clinical trial of LUTATHERA® plus octreotide LAR 30mg vs active control (octreotide LAR 60mg*).4 Dr Enrique Grande, MD Anderson Cancer Center, Madrid, Spain, reviews the final OS analysis, conducted after a median follow-up of more than 6 years in the NETTER-1 study.4
*High-dose octreotide LAR 60mg is not the licensed dose.
3/5 Next ChapterHealth-related quality of life with LUTATHERA®
Dr Henning Jann, Charité University Hospital, Berlin, Germany, describes results from NETTER-1 which demonstrated statistically significant and clinically robust quality of life benefits for patients with inoperable, progressive midgut NET receiving LUTATHERA® plus octreotide LAR 30mg vs. active control (octreotide LAR 60mg*).2
*High-dose octreotide LAR 60mg is not the licensed dose.
4/5 Next ChapterLong-term safety profile of LUTATHERA®
Dr Nicola Fazio, European Institute of Oncology, Milan, Italy, discusses the overall safety profile of LUTATHERA®, based on pooled data from clinical studies (NETTER-1 pivotal Phase 3 clinical trial and Erasmus Phase1/2 clinical trial in Dutch patients) and from compassionate use programs.5
5/5 Leave FeedbackLearning Objectives & Overview
Overview
NETTER-1 is an international Phase 3 clinical trial comparing LUTATHERA® plus best supportive care (30mg octreotide long-acting repeatable [LAR]) vs. high-dose octreotide LAR 60mg*) for patients with inoperable, progressive, somatostatin receptor (SSTR)-positive midgut neuroendocrine tumours (NET).1 Results demonstrate significantly improved progression-free survival, quality of life benefits and symptom reduction in the LUTATHERA® arm vs. high-dose octreotide LAR 60mg.1-3
*High-dose octreotide LAR 60mg is not the licensed dose.
Learning Objectives
After watching this activity, participants should be better able to:
- Recall the mechanism of action of LUTATHERA®4,5
- Recall the objectives and design of the NETTER-1 study1
- Describe the efficacy of LUTATHERA® in patients with midgut NET1-4
- Discuss symptom control and quality of life outcomes from NETTER-12,3
- Describe the long-term safety profile of LUTATHERA®4,5
Adverse Events
Adverse Events
Adverse events should be reported by accessing this link: https://www.adacap.com/pharmacovigilance/
References
References
- Strosberg J, El-Haddad G, Wolin E, et al. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med. 2017;376(2):125-135.
- Strosberg J, Wolin E, Chasen B, et al. 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. 2018;36(25):2578-2584.
- Strosberg JR, Srirajaskanthan R, El-Haddad G, et al. Symptom Diaries of Patients with Midgut Neuroendocrine Tumors Treated with 177Lu-DOTATATE. J Nucl Med. 2021;62(12):1712-1718.
- Strosberg JR, Caplin ME, Kunz PL, et al. 177Lu-Dotatate plus long-acting octreotide versus high‑dose long-acting octreotide in patients with midgut neuroendocrine tumours (NETTER-1): final overall survival and long-term safety results from an open-label, randomised, controlled, phase 3 trial [published correction appears in Lancet Oncol. 2022 Feb;23(2):e59]. Lancet Oncol. 2021;22(12):1752-1763.
- LUTATHERA Summary of Product Characteristics. 14 July 2022. Available at: www.ema.europa.eu/documents/product-information/lutathera-epar-product-information_en.pdf (accessed July 2022).