“Findings from the phase III NETTER-1 trial led to the January 2018 FDA approval of Lutathera (lutetium Lu 177 dotatate) for the treatment of patients with somatostatin receptor–positive gastroenteropancreatic tumors (GEP-NETs). The trial compared Lutathera with high-dose octreotide LAR for patients with 1 or 2 metastatic midgut NETs.
“In NETTER-1, patients with midgut NETs who progressed on 30 mg of octreotide were randomized to Lutathera (n = 116) or high-dose octreotide (n = 113). Patients received 4 doses of Lutathera at 7.4 GBq every 8 weeks in combination with 30 mg of octreotide. The control arm received 60 mg of octreotide LAR every 4 weeks.”
“The U.S. Food and Drug Administration today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs.”
“Matthew H. Kulke, MD, MMSc, has been a leader in the development of new therapies and clinical management strategies for patients with neuroendocrine tumors (NETs).
“In a recent milestone, Kulke presented phase III clinical trial data at the 2015 European Cancer Congress indicating that telotristat etiprate, a novel tryptophan hydroxylase inhibitor, improves diarrhea control in combination with a somatostatin analog for patients with metastatic NETs and inadequately controlled carcinoid syndrome. In the clinical arena, Kulke serves as co-chair for the National Comprehensive Cancer Network guidelines panel on NETs and also is an active member of medical society advisory boards and task forces related to NETs.”
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Neuroendocrine tumors of the digestive system (GI-NETs) can arise in different parts of the digestive tract. GI-NETs originating in the ileum, duodenum, and appendix are known as midgut NETs, and tumors of the stomach, colon, and rectum are non-midgut NETs. Many of these tumors are functional; that is, they produce a variety of hormonal substances that cause serious, debilitating symptoms. Continue reading…
“The radiopharmaceutical Lu-Dotatate (177Lutetium DOTATATE; Lutathera) demonstrated an unprecedented 79% reduction in the risk of progression or death compared with high-dose octreotide LAR (60 mg) in patients with progressive, metastatic midgut neuroendocrine tumors (NETs), according to results from NETTER-1 trial presented by Jonathan Strosberg, MD, at the 2015 NANETS Symposium.”
” ‘The findings were, in my opinion, extraordinarily impressive, the median progression-free survival improved by nearly 80%, which is fairly unprecedented in oncologic studies,’ said Strosberg, a medical oncologist and researcher at the Moffitt Cancer Center. ‘The finding is important because limited therapeutic options exist for such patients, who comprise 20% to 45% of neuroendocrine tumor cases.’ ”
“The NETTER-1 trial is the first prospective, randomized, phase III study for patients with midgut NETs, specifically those in the ileum and cecum. Patients in the trial had progressed on prior therapy with octreotide at 30 mg and had inoperable, somatostatin receptor positive tumors.”
“Lexicon Pharmaceuticals, Inc.’s (Nasdaq: LXRX) telotristat etiprate was shown to have clinical benefit in treating carcinoid syndrome in cancer patients not adequately controlled by long-acting somatostatin analog (SSA) therapy, the current standard of care, according to data from the Phase 3 TELESTAR study presented today at the European Cancer Congress in Vienna, Austria.
“Telotristat etiprate, Lexicon’s most advanced product candidate, met the study’s primary endpoint with clinically meaningful reductions in bowel movement frequency in patients whose condition was not adequately controlled by SSA therapy. Carcinoid syndrome is characterized by frequent and debilitating diarrhea that often prevents patients from leading active, predictable lives, as well as by facial flushing, abdominal pain, heart valve damage and other serious consequences.
” ‘We are pleased with the efficacy and safety results of telotristat etiprate and also with the durability of the response shown in this study,’ said Lexicon Executive Vice President and Chief Medical Officer Pablo Lapuerta, M.D. ‘The data also support that the compound is acting directly on the cause of carcinoid syndrome, by reducing serotonin production within tumor cells.’ “
Pancreatic neuroendocrine tumors (PNETs) constitute only about 3% to 5% of all pancreatic cancers. Compared to the most common pancreatic cancer—adenocarcinoma (aka exocrine tumors), PNETs have a longer disease course and better prognosis; the 5-year survival rate is 42% for PNETs, but only about 5% to 6% for adenocarcinomas. When PNETs are localized, they can usually be removed by surgery. However, PNETs tend to metastasize, most often to the liver, and present a formidable treatment challenge at this stage. Continue reading…
Cancers that arise in the lung are mostly of the type known as NSCLC (non-small cell lung carcinoma). A much smaller proportion of lung tumors arise from neuroendocrine cells in the lungs. These cells (which are also found in most other organs) secrete a variety of hormones that are necessary for normal organ function, as well as for healing after injury or infection. Like other lung cells, neuroendocrine cells may transform to become cancers. Lung cancers that arise from neuroendocrine cells are called pulmonary neuroendocrine tumors (NETs), or lung NETs. Continue reading…
Neuroendocrine tumors (NETs) can arise wherever neuroendocrine (hormone-producing) cells are found—which is in most organs. Most NETs (65%-70%) are gastroenteropancreatic, or GEP, arising in different gastrointestinal organs. GEP-NETs are most commonly found in the small bowel (including the appendix), stomach, and rectum. Still, NETs in general are rare, which complicates the development of new treatments and identification of the genetic drivers of these cancers. Treatment of GEP-NETs is clearly an unmet medical need, and is now even more urgent because their incidence has been on the rise in the last 20 years. Continue reading…