“In December 2016, the FDA informed Advanced Accelerator Applications that its new drug application for Lutathera (177Lutetium DOTA-octreotate) as a treatment for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) would need to be resubmitted.
“The application was based on the phase III NETTER-1 trial, which randomized patients with advanced, progressive, somatostatin receptor-positive midgut NETS to receive either Lutathera (116 patients) plus best supportive care, including octreotide long-acting repeatable (LAR), or octreotide LAR alone (113 patients).”
“A growing number of patients with cancer are benefitting from research advances in immunotherapy, leading the American Society of Clinical Oncology (ASCO) to name immunotherapy as the Society’s advance of the year for a second year in a row. Released today, this year’s report, Clinical Cancer Advances 2017: ASCO’s Annual Report on Progress Against Cancer highlights the expanding role of immunotherapy. Evolving research findings are providing new insights on how to get the optimal results from these relatively new treatments.”
“A few weeks ago, I was watching veg-out TV, quietly wondering to myself how a show called ‘Pure Genius’ could be so darned dumb.
“Then a commercial break added a new sort of mystification: A long, vivid ad touted the cancer drug Opdivo, a form of immunotherapy — an exciting new type of treatment that harnesses the body’s own immune system — for lung cancer.
“Lung cancer is the biggest cancer killer, so, in this anomalous country that allows direct-to-consumer drug ads, it was no surprise to see a lung cancer ad on network TV.”
“In a single-arm phase II study, cabozantinib demonstrated clinical activity in patients with advanced carcinoid and pancreatic neuroendocrine tumors (pNETs). Partial responses (PRs) were observed in 15% of each cohort treated with cabozantinib and stable disease was the best response in about two-thirds of patients.
“Median progression-free survival (PFS) exceeded 20 months in the pNET cohort and was >30 months in the carcinoid tumor cohort, said Jennifer A. Chan, MD, at the 2017 Gastrointestinal (GI) Cancers Symposium.”
“Patients with small intestine neuroendocrine tumors often have mesenteric tumor deposits (MTDs) in the abdomen – discrete tumor nodules that are not connected to the primary tumor. The clinical significance of these tumor deposits has not been thoroughly investigated, and they are not included in the American Joint Committee on Cancer (AJCC) staging system for midgut neuroendocrine tumors.
“Chanjuan Shi, M.D., Ph.D., and colleagues examined the prognostic significance of MTDs associated with midgut neuroendocrine tumors in 132 patients. Using pathologic slides from resected tumors and electronic medical records, the researchers reviewed AJCC tumor stage, lymph node and liver metastasis, presence of MTDs and survival data.”
“A new therapy in development for the treatment of midgut neuroendocrine tumors, a rare type of cancer that occurs in the small intestine and colon, shows improved progression-free survival and response rates for patients with advanced disease. Results of the international phase 3 clinical trial of lutetium-177 (177Lu)-Dotatate compared to high-dose octreotide LAR were published in the Jan. 12 issue of the New England Journal of Medicine.
” ‘Patients diagnosed with midgut neuroendocrine tumors often have advanced disease that has spread to other sites. Treatment options are limited. 177Lu-Dotatate is an effective option to delay tumor progression for patients with this disease,’ says Jonathan R. Strosberg, head of the Neuroendocrine Tumor Program at Moffitt Cancer Center. ‘There is also preliminary evidence of survival benefit that requires confirmation on final survival analysis, expected in several years.’ ”
“The FDA has issued a complete response letter (CRL) to Advanced Accelerator Applications informing the company that its new drug application for Lutathera (177Lutetium DOTA-octreotate) as a treatment for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) would need to be resubmitted.
“The CRL, which follows a discipline review letter (DRL) issued in November, requests new subgroup data, a safety update, and that revisions be made to the previously submitted data. The letter did not request the initiation of additional studies of Lutathera.”
“Who might benefit from a clinical trial for an experimental cancer treatment?
“A common misperception is that such trials are strictly for patients who have reached the end of the road and have no more hope of being helped by standard treatments.
” ‘But it’s not last-ditch,’ said Dina G. Lansey, the assistant director for diversity and inclusion in clinical research at the Johns Hopkins Kimmel Cancer Center. New forms of immunotherapy are being tested in many types of cancer, and not just at late stages.”
“Advanced Accelerator Applications S.A. …an international specialist in Molecular Nuclear Medicine (MNM), today announced its financial results for the third quarter of 2016 and that the U.S. Food and Drug Administration (FDA) issued feedback on its New Drug Application (NDA) for Lutathera® for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.”