Lu-Dotatate (Lutathara) produced progression-free survival in patients with progressive, metastatic, midgut, neuroendocrine tumors (NETS), compared with octreotide LAR, according to results from NETTER-1. The study showed Lu-Dotatate patients had a 79% reduced risk of disease progression or death.
What is NETS?
Neuroendocrine tumors (NETs) are rare tumors that develop in cells of the neuroendocrine system. There are a number of different types of neuroendocrine tumor.
Some NETs produce extra hormones and cause symptoms. There are many kinds of NETs, they are treated
as a group of tissue because the cells of share common features, such as looking similar, having special secretory granules, and often producing the same type of hormones.
“NETTER-1 is the first prospective, randomized, Phase 3 study of such patients,” said Jonathan Strosberg, MD, oncologist and researcher at Moffitt Cancer Center. "The finding is important because limited therapeutic options exist for such patients, who comprise 20 – 45% of neuroendocrine tumor cases."
NETTER-1 is a randomized phase 3 study or patients with inoperable, somatostatin receptor positive, midgut neuroendocrine tumors. Patients in the trial were previously progressing on 30 mg dose of octreotide. In the study, 230 patients received octreotide LAR 60 mg every 4 weeks or 4 administrations of Lu-Dotatate 7.4 GBq every 8 weeks, plus renal protection via amino acid solution infusion. Additionally, Lu-Dotatate patients received 30 mg octreotide LAR for symptom control
Interim results showed the median progression-free survival had not been reached for Lu-Dotatate, compared to 8.4 months for octreotide. Among 230 patients in the study, 13 Lu-Dotatate patients died, compared to 22 deaths in the octreotide group. Disease progressed in 4 percent of the Lu-Dotatate group and 24% of the octreotide group. Stable disease was almost the same for both groups.
Among Lu-Dotatate patients, 18 showed a partial response, compared to 3 octreotide patients.
According to Strosberg, safety data confirmed favorable results of the preceding phase 1 and 2 studies. Serious adverse events related to treatment were 9% for Lu-Dotatate and 1% for octreotide. Withdrawals due to adverse events were 5 percent for Lu-Dotatate and 0% for octreotide.
The ongoing study includes an 18-month accrual period (completed) plus a 5-year follow-up starting from the last patient’s randomization date. Every 12 weeks, evaluators use the RECIST 1.1 criteria to assess tumor response in both arms. Patients remain under treatment until disease progression, unacceptable toxicity or inability/unwillingness to comply with study requirements.
Main secondary endpoints are objective response rate, overall progression, time to progression, safety, tolerability and health-related quality of life. In a subset of patients, dosimetry, pharmacokinetics and ECG evaluations are also performed.