Moffitt Researchers Report Improved Progression-Free Survival and Responses Rates for Lutathera over Octreotide in Patients with Progressive Metastatic Midgut Neuroendocrine Tumors

June 03, 2016

TAMPA, Fla. Moffitt Cancer Center will present results of the phase 3 NETTER-1 study, showing clinically meaningful and significant results for Lutathera (77Lu-DOTA0-Tyr3-Octreotate) in patients with metastatic midgut neuroendocrine tumors (NETs). The data will be presented Monday, June 6, during the American Society of Clinical Oncology Annual Meeting in Chicago.

Somatostatin analogs, such as Octreotide LAR, are commonly used to treat NETs. They reduce hormone-related symptoms and stabilize the tumor. However, patients who develop advanced midgut NETs that progress after somatostatin analog therapy have few effective treatment options. 

Lutathera is a radiolabeled (Lu-177) somatostatin analogue that functions similar to standard somatostatin analogs, but also delivers toxic radiation directly to the tumor.  Lutathera has received orphan drug status from the European Medicines Agency and the U.S. Food and Drug Administration.

The NETTER-1 phase 3 trial compares Lutathera to Octreotide LAR in patients with inoperable midgut carcinoid tumors that progressed following Octreotide LAR and express the somatostatin receptor.

Results to date in 230 randomized patients show improved outcomes for patients treated with Lutathera over Octreotide LAR.  Median progression-free survival (PFS) was not reached in the Lutathera arm and was 8.4 months in the Octreotide LAR arm (P < 0.0001, HR 0.21), while the objective radiographic response rate (ORR) was 19% for Lutathera treated patients and 3% for Octreotide treated patients (P = 0.0008).

The safety profile of Lutathera was also favorable, with only 5% of patients experiencing a toxicity that led to a dose modification. Grade 3 or 4 adverse events were low, with the most common being neutropenia (1%), thrombocytopenia (2%) and lymphopenia (9%)

Jonathan Strosberg, M.D., associate member of the Gastrointestinal Oncology Department at Moffitt, will present the study results on June 6 during the 8 a.m. gastrointestinal cancer oral abstract session in Hall B1 at McCormick Place.

About Moffitt Cancer Center

Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. One of the three largest cancer centers in the United States based on patient volume, the Tampa-based facility is one of only 45 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s excellence in research, its contributions to clinical trials, prevention and cancer control. Moffitt is the top-ranked cancer hospital in Florida and has been listed in U.S. News & World Report as one of the “Best Hospitals” for cancer care since 1999. Moffitt devotes more than 2 million square feet to research and patient care. With more than 5,000 team members, Moffitt has an economic impact in the state of $1.9 billion. For more information, call 1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org, and follow the Moffitt momentum on Facebook, Twitter and YouTube.

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Media Contact at ASCO:

Kim Polacek

813-507-3173

Kim.Polacek@Moffitt.org