CHMP Recommends Approval of Everolimus for GI, Lung NETs

Excerpt:

“Everolimus (Afinitor) has received a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) as a treatment for patients with progressive, unresectable or metastatic, well-differentiated nonfunctional gastrointestinal (GI) or lung neuroendocrine tumors (NETs).

“The positive opinion suggests the mTOR inhibitor everolimus is likely to be approved in this setting when the European Commission issues its final decision.

“CHMP based its recommendation on data from the phase III RADIANT-4 trial. In the study, median progression-free survival (PFS) was 11 months with everolimus versus 3.9 months with placebo, representing a 52% reduction in the risk of progression or death (HR, 0.48; 95% CI, 0.35-0.67; P <.00001).”

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FDA Approval Sought for Telotristat Etiprate for Carcinoid Syndrome

Excerpt:

“A new drug application (NDA) has been submitted to the FDA for telotristat etiprate as a treatment for carcinoid syndrome in patients with metastatic neuroendocrine tumors (NETs), according to a statement from the drug’s developer, Lexicon Pharmaceuticals.

“The application was based on data from two phase III trials, both of which demonstrated significant reductions in the frequency of daily bowel movements with telotristat etiprate versus placebo. In the first study, TELESTAR, telotristat etiprate reduced daily bowel movements by up to 35%. In the second study, TELECAST, there was also a significant reduction in bowel movements (P ≤.004), although the exact data were not yet released.

“The FDA will review the NDA within 60 days of submission, at which point the agency will assign a review deadline under the Prescription Drug User Fee Act. Lexicon requested a priority review for the NDA, which would provide a 6-month deadline if the designation is granted.”

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New Treatments for Gastrointestinal Neuroendocrine Tumors


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…


Another Indication OK'd for Afinitor

“Everolimus (Afinitor) is now approved for treating inoperable, locally advanced or metastatic neuroendocrine tumors of gastrointestinal or lung origin, the FDA said Friday.

“The agency further specified that the tumors should be ‘progressive, well-differentiated [and] non-functional.’

“Approval was based primarily on a 302-patient trial comparing everolimus with placebo, both in combination with best supportive care. Median progression-free survival was 11 months in the active-drug arm compared with 3.9 months for placebo. However, in an interim analysis, there was no difference in overall survival, and response rates (i.e., achieving significant tumor shrinkage) were 2% with everolimus and 1% with placebo.”


Expert Discusses Emerging Treatments, Immunotherapy Potential in pNETs

“Several recent studies have shown promise for the treatment of pancreatic NETs (pNETs). In the phase II CALGB-80701, which investigated the addition of bevacizumab (Avastin) to a treatment paradigm of everolimus and octreotide (Sandostatin) LAR in patients with locally advanced or metastatic pNETs, bevacizumab extended progression-free survival (PFS) by more than 3 months compared with everolimus and octreotide LAR alone.

“Response rate was also higher in the bevacizumab arm, with a 31% response to everolimus plus bevacizumab versus a 12% response in the control arm. Toxicity, however, was significantly higher in the bevacizumab arm.”


Video: Efficacy of Lanreotide for the Treatment of Neuroendocrine Tumors

“Martyn E. Caplin, professor, lead clinician, Neuroendocrine Unit at the Royal Free Hospital, London, discusses the efficacy of lanreotide for the treatment of patients with neuroendocrine tumors, as shown in clinical trials such as the CLARINET study.”

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Full Surgical Resection Should Be Performed Whenever Possible for Gastroenteropancreatic NETs

“Full surgical resection (R0) of gastroenteropancreatic neuroendocrine tumors (NETs) is associated with a greater than 90% survival rate at five years, according to findings presented at the 2015 North American Neuroendocrine Tumor Society (NANETS) symposium. The rate of recurrence varied by tumor location and stage, but the majority of patients with all types of NETs who underwent full resection were still free of recurrence in the five-year time frame.

“ ‘The presence of metastatic disease does not seem as though it should deter attempts at R0 resection when it’s feasible,’ according to lead author Katherine Van Loon, MD, MPH, a gastrointestinal cancer specialist at the University of California, San Francisco, Medical Center. She noted that there were differences in disease-free survival in patients who had NETs in the pancreas and small bowel depending on their stage at diagnosis, but a significant difference in overall survival was not detected.

“Current NCCN guidelines recommend that patients with gastrointestinal NETs undergo complete resection of the primary tumor and metastases whenever possible, but until now, large multicenter studies looking at recurrence rates in patients who undergo this procedure have not be conducted.”


Biomarker Needed for CAPTEM Regimen in Metastatic Pancreatic NETs

“Treatment with capecitabine and temozolomide (CAPTEM) is an effective therapy for patients with metastatic pancreatic neuroendocrine tumors (pNETs), but the efficacy of several predictive markers previously thought to determine which patients might respond to the regimen could not be validated, according to a presentation at the 2015 NANETS Symposium.

“ ‘In our study we tried to assess the role of potential predictors of response to temozolomide-based regimens in metastatic pNETs,’ according to lead author Mauro Cives, MD, who presented the findings at the 2015 North American Neuroendocrine Tumor Society symposium. The markers the investigators evaluated were expression of MGMT, proliferative activity, and ALT activation.

“Investigators looked at 143 patients with metastatic pNETs treated at Moffitt who had undergone therapy with CAPTEM and retrospectively evaluated them for radiographic response. ‘This is the largest reported cohort of pNET patients treated with temozolomide-based chemotherapy,’ said Cives, a research associate in the Department of GI Oncology at the Moffitt Cancer Center and Research Institute in Tampa, Florida.”


Video: Dr. Kunz on Potential of Immunotherapy in Neuroendocrine Tumors

“Pamela L. Kunz, MD, assistant professor of Medicine (Oncology), Stanford University School of Medicine, discusses the potential of immunotherapy in the treatment of patients with neuroendocrine tumors (NETs).

“There are currently some clinical trials under development looking at immunotherapy in NETs both at Stanford University School of Medicine and University of Pennsylvania, Kunz explains. One phase I/II trial will examine the safety and efficacy of intratumoral injection of ipilimumab combined with an anti—PD-L1 agent in these patients.”

“It is possible that immunotherapy agents could be agnostic to disease sites, Kunz says. Though it was originally believed that PD-1/PD-L1 expression is a requirement to be a predictive biomarker, additional research could show that it may not be necessary.”

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