60% of patients with neuroendocrine tumours, the cause of carcinoid syndrome diarrhoea, say that it severely impacts their quality of life and emotional health.
The UK affiliate of Ipsen (Euronext: IPN; ADR: IPSEY) last month announced that Xermelo® (telotristat ethyl) has been recommended by the All Wales Medicines Strategy Group (AWMSG) for use within NHS Wales for the treatment of adult patients living with carcinoid syndrome (CS) diarrhoea. Telotristat ethyl, which is administered orally in combination with somatostatin analogue (SSA) therapy, is a treatment for CS diarrhoea in adult patients living with neuroendocrine tumours (NETs) who are inadequately controlled by SSA therapy. With 49% of UK cancer patients now surviving five years or more post-diagnosis this announcement underlines the importance of a patient’s quality of life throughout the cancer journey.
NETs are rare, slow-growing cancers of the body’s neuroendocrine system. This system is responsible for the production of hormones which are released into the bloodstream, therefore the presence of NETs can disturb the hormone balance within the body and trigger an over-production of serotonin. When serotonin is present in large amounts within the body, it can disrupt a number of bodily processes causing diarrhoea, flushing, wheezing and cardiac damage. CS is the terminology used to classify this collection of symptoms.
“Today’s approval of telotristat ethyl by NHS Wales is a positive step forward for patients with neuroendocrine tumours and carcinoid syndrome given how severely it can impact their quality of life. TELESTAR demonstrated that telotristat ethyl significantly reduced the number of daily bowel motions in carcinoid syndrome patients compared with placebo. We hear these patients describe disruption of their home and work lives and that they seek psychological support as a result of their carcinoid syndrome. Managing patients’ symptoms, in particular gastrointestinal symptoms, can sometimes have a greater impact on a person’s daily life than the cancer itself, and therefore is a focus of NET care alongside disease management” said Dr Mohid Khan, Clinical Lead, Wales Neuroendocrine Tumour Service, Consultant in Gastroenterology & Neuroendocrine Tumours at University Hospital of Wales.
CS is incurable in over 95% of patients and it has been estimated that there are currently approximately 10,000 people living with CS in Europe. The disease can cause a range of symptoms with one of the most common being diarrhoea, which affects 75% of patients. Diarrhoea can negatively affect a patient’s emotional, social and physical well-being with over 10% of patients having seven or more bowel movements a day. Most patients (92%) reported making one or more lifestyle changes a result of NETs including dietary changes (58%), seeing a therapist for emotional aspects of the disease (20%), taking days off from work (49%), reducing their work hours (24%) and having to stop working altogether (82%). It is anticipated that in Wales, less than 20 patients would be eligible for treatment.
Matthew Hickling, Medical Director, Ipsen UK & Ireland commented on today’s announcement, saying: “We are delighted by the AWMSG’s decision to allow patients with carcinoid syndrome diarrhoea in Wales access to a much-needed treatment that will ensure all patients can lead a better quality of life during their cancer journey. We’d like to thank all parties involved in the appraisal process for Wales, which closely follows NHS reimbursement of Xermelo in Scotland in June. Both decisions are a step in the right direction – as patients don’t have time to wait.”
The New Medicines Group (NMG) Assessment report is based on the pivotal study, TELESTAR, which was a phase 3, international, multicentre, randomised, double-blind, study that compared use of telotristat ethyl with placebo in patients with inadequately controlled CS diarrhoea, despite receiving SSA therapy. Patients in both arms of the study also received stable dose SSA therapy. The study showed that:
· 44% of patients who received telotristat ethyl 250mg three times daily achieved a durable response, defined as at least a 30% reduction in daily bowel movements over at least half the days of the 12-week double-blind treatment (DBT), compared to 20% on placebo.
· Urinary 5-hydroxyindole acetic acid (u-5HIAA; a metabolite of serotonin) was significantly reduced in patients receiving telotristat ethyl versus placebo at week 12 (p< 0.001).
The most commonly reported adverse reactions in patients treated with telotristat were abdominal pain (26%), gamma-glutamyl transferase increased (11%) and fatigue (10%). They were generally of mild or moderate intensity. The most frequently reported adverse reaction leading to discontinuation of telotristat was abdominal pain in 7.1% of patients (5/70).