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First-line treatment with lanreotide for metastatic neuroendocrine tumours

03 Mar 2016

The Drug Control Authority (DCA) of Malaysia has approved a new indication for the long-acting somatostatin analogue lanreotide. This new indication is for the treatment of grade 1 and low grade 2 gastroenteropancreatic neuroendocrine tumours (GEP-NETs)—of midgut, pancreatic or unknown origin except the hindgut—in adult patients with unresectable locally advanced or metastatic disease.

The approval was based on the results of the Controlled Study of Lanreotide Anti-proliferative Response in Neuroendocrine Tumours (CLARINET), which showed that lanreotide was associated with significantly prolonged progression-free survival (PFS) compared with placebo  among patients with metastatic GEP-NETs of grade one or two. [N Engl J Med 2014;371:224–233]

The randomized, double-blind, placebo-controlled, multinational study was performed in patients with advanced, well- or moderately-differentiated, nonfunctioning, somatostatin receptor-positive grade one or two NETs (immunostaining of the primary tumour for the Ki-67 antigen of up to 10 percent). Primary tumours were located in the pancreas, midgut, and hindgut or were of unknown origin. Patients were either treated with an extended-release aqueous-gel formulation of lanreotide at a dose of 120 mg or administered placebo (sodium chloride) by means of deep subcutaneous injection every 28 days for 96 weeks.

The primary analysis showed that lanreotide significantly prolonged PFS (defined according to Response Evaluation Criteria in Solid Tumours [RECIST]) compared with placebo (median not reached vs median of 18 months, p<0.001). [Figure 1] The estimated PFS at 24 months were 65.1 percent [95 % confidence interval (CI), 54.0–74.1] and 33.0 percent [95 %CI, 23.0–43.4], respectively in the lanreotide and placebo groups.

Secondary analyses showed that hazard ratios for disease progression and death in predefined subgroups favoured lanreotide over placebo, with the exception of a small subgroup of patients with tumours originating in the hindgut. The risk of disease progression within 96 weeks after the first dose of lanreotide was reduced by 53 percent.

In terms of safety, similar proportions of patients in the two groups experienced adverse events, with the majority reporting mild or moderate events. The most common adverse event following treatment with lanreotide were gastrointestinal disorders such as diarrhoea and abdominal pain, which are well known adverse events documented for Somatostatin analogue

The approval of lanreotide (Somatuline® Autogel®) in Malaysia was welcomed by Dr. Nick Chia, medical director specialty care South Asia of Ipsen in Singapore who said: “I am delighted with the approval of this new indication for Somatuline, which is a testimony to the scientific quality of our clinical results. Ipsen is now launching Somatuline Autogel in Malaysia in partnership with Menarini Pte Ltd as the first and only somatostatin analogue to be licensed as an anti-tumour agent for the treatment of both pancreatic and midgut neuroendocrine tumours.”

Neuroendocrine tumours have diverse origins but often start in the gastrointestinal system. They are slow growing and heterogeneous. These tumours are considered to be relatively rare but with a rapidly increasing prevalence. Primary treatment for NETs involves surgical and medical therapies, with tumour grade, primary and metastatic sites, and level of tumour hormone secretion playing a part in determining the specific types of treatment and patients’ overall prognoses.

The secretion of bioactive peptides and neuroamines, including serotonin, histamine, prostaglandin and insulin are observed in NETs, prompting the idea of exploring hormonal therapy, such as somatostatin. Native somatostatin inhibits the release of neuroendocrine hormones but has a very short half-life, making it unsuitable for treatment.

As a somatostatin analogue, lanreotide binds to somatostatin receptors, which primarily results in reduced growth hormones and insulin-like growth factor-1 levels, slowed growth and proliferation of NETs, increased apoptosis, as well as inhibition of cell signaling and protein synthesis. [Expert Opin Pharmacother 2016;17:443–456]  Lanreotide has also the added advantage of a unique formulation using liquid crystal technology allowing for sustained release, with a high concentration of peptide in water.

Somatuline Autogel is presented in a small volume (<0.5 mL) ready-to-use, prefilled syringe. It does not require reconstitution and therefore avoids the risk of clogging and potential wastage, offering a streamlined process that supports full dose delivery,makes it possible for the patient or his/her partner or family to administer the injection themselves.  This will increase patient independence and reduce the number of clinic visits. 
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