NICE recommends Servier's bowel cancer treatment

Wexham (UK), 24th August 2016 – Servier UK today announced that, following a single technology appraisal,  National Institute for Health and Care Excellence (NICE) has issued final guidance recommending LONSURF ® (trifluridine/tipiracil), for the treatment of adult patients with metastatic colorectal cancer (bowel cancer) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents for use within England.1 The full recommendation can be found here: www.nice.org.uk/guidance/ta405

This announcement comes at a time when there is a real need for further treatment options for patients with refractory metastatic colorectal cancer, or what may also be referred to as advanced bowel cancer. In light of the changing funding landscape for oncology agents within the UK, the addition of new products in later lines of therapy could be crucial to those patients.

Servier welcomes NICE’s decision and the positive news it brings for patients with metastatic colorectal cancer and their families. The decision by NICE arrives four months after the European Commission granted trifluridine/tipiracil a Marketing Authorisation and represents a milestone in Servier’s evolution. Servier is an international pharmaceutical company, with no shareholders, governed by a non-profit Foundation. And trifluridine/tipiracil is Servier UK’s first cancer treatment. The recommendation from NICE underpins the company’s commitment to research in the field of oncology and its philosophy of delivering life-enhancing medicines to the patients who need them.

Dr Rob Glynne-Jones, Consultant Oncologist and Macmillan Lead Clinician in Gastrointestinal Cancer at the Mount Vernon Cancer Centre said“There are not many options left when a patient has had previous treatments. Lonsurf is potentially a valuable new drug that I can offer to my patients with metastatic colorectal cancer regardless of their RAS status or resistance to previous lines of treatment.  It’s great news that NICE has recommended Lonsurf - because I now have a treatment that could give my patients some extra time”

The NICE committee took end-of-life considerations in to account, appraising thesurvival benefit with trifluridine/tipiracil in the context of the life expectancy of patients with metastatic colorectal cancer1 NICE concluded that, as a third- or subsequent-line treatment for metastatic colorectal cancer, trifluridine/tipiracil represents a well-tolerated treatment that would help extend life by even a relatively short time, while maintaining a reasonably good quality of life at a late stage in the treatment pathway when there are no further options left.1

In coming to their decision, the NICE appraisal committee considered evidence from a large international study called the RECOURSE trial.2 The clinical trial looked at survival (efficacy) and safety (side effects), comparing patients taking trifluridine/tipiracil whilst receiving best supportive care, to patients taking placebo (dummy pill) plus best supportive care.2 In the clinical trial trifluridine/tipiracil significantly improved how long a patient survived.2,3 Patients taking trifluridine/tipiracil survived for 2 months longer than patients taking the placebo.3  The median overall survival improved from 5.2 months with placebo to 7.2 months with trifluridine/tipiracil.3 The 1 year survival rate with trifluridine/tipiracil was 27.1% vs.16.6% with placebo.3

The most frequently observed side effects in patients receiving trifluridine/tipiracil were nausea (feeling sick), diarrhoea, fatigue (extreme tiredness), decreased appetite, anaemia (low red blood cells), neutropenia (a low level of neutrophils, a type of white blood cell that help the body fight infection), leucopenia, (a low level of leucocytes, a type of white blood cell that help the body fight infection), thrombocytopenia (a low level of platelets, a type of cell that helps the blood clot), increase in AST (a liver enzyme), increase in total bilirubin level (a breakdown product from old red blood cells), increase in alkaline phosphatase level (a liver enzyme).2,4

Following publication of NICE guidance recommending the use of a treatment, NHS Trusts in England have 90 days to ensure funding is available at a local level and eligible patients have access to treatment. As trifluridine/tipiracil has been recommended by NICE and given that Servier is participating in the industry agreement with the Cancer Drugs Fund, trifluridine/tipiracil will be funded immediately, thereby avoiding delays in appropriate patients receiving this new treatment.5                                                           

ENDS

Servier UK Media Contact:           Tel: +44 (0) 1753 662744          Email: pressoffice-uk@servier.com

Servier UK Medical Information:   Tel: +44 (0) 1753 666409          Email: medical.information-uk@servier.com

Notes to Editor

About Metastatic Colorectal Cancer               

Colorectal cancer also called bowel cancer, is the second leading cause of cancer-related deaths in the UK6 and Europe.7 In 2012, 215,000 people died from the disease across Europe7, with 16,200 (44/day) of those people being from the UK.7 As such there remains a high unmet need in the treatment of colorectal cancer.

There were around 41,100 new cases of colorectal cancer in the UK in 2013, which equates to 110 cases diagnosed every day.6 Colorectal cancer is the fourth most common cancer in the UK (2013), with 1 in 14 men and 1 in 19 women diagnosed with colorectal cancer during their lifetime.6

Approximately 25% of patients with colorectal cancer present with metastases at initial diagnosis, whereby cancer cells have spread from the original tumour site to another part of the body, and almost 50% of patients with colorectal cancer will develop metastases.7   When diagnosed at its earliest stage, more than 9 in 10 people with colorectal cancer will survive their disease for five years or more, compared with fewer than 1 in 10 people when diagnosed at the latest stage.6

About LONSURF® (trifluridine/tipiracil)

Trifluridine/tipiracil is approved in the European Union (EU) for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.4 Trifluridine/tipiracil is currently available in Japan for the treatment of unresectable advanced or recurrent colorectal cancer  and in the United States for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine -, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.8-10 Trifluridine/tipiracil is an oral combination anticancer drug of trifluridine and tipiracil.4 Trifluridine is an antineoplastic nucleoside (thymidine-based) analogue which means it is similar to one of the building blocks used to make DNA (DNA tells a cell how to behave).4,11 Cancer cells recognise trifluridine as a building block and use it to make DNA causing the cell to die. 4,11  Tipiracil slows the breakdown of trifluridine in the body, allowing for oral administration and  keeping the blood concentration high enough for trifluridine to be taken up by cancer cells.4,11  The primary mechanism of action of trifluridine/tipiracil differs from a drug class called fluoropyrimidines, and therefore it may be an option for patients who are not responding to (are resistant to) fluoropyrimidines.4,11,12

In June 2015, Servier entered into an exclusive license agreement with Taiho Pharmaceutical Co., Ltd. for the co-development and commercialization of trifluridine/tipiracil. Under the terms of the agreement, Servier has the rights to co-develop and commercialise trifluridine/tipiracil in Europe and other countries outside of the United States, Canada, Mexico and Asia. Taiho Pharmaceutical retains the right to develop and commercialise trifluridine/tipiracil in the United States, Canada, Mexico, and Asia and to manufacture and supply the product. 

About Servier

Servier is an international pharmaceutical company governed by a non-profit Foundation, with no shareholders and headquartered in France. With a strong international presence in 148 countries and a turnover of 3.9 billion euro in 2015, Servier employs over 21,200 people worldwide. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiology, oncology, metabolism, neuropsychiatry and rheumatology, as well as by its activities in high quality generic drugs. Being completely independent, the Group reinvests 25% of Servier’s products turnover in Research and Development, and all its profits in its growth. Becoming a key player in oncology is part of Servier’s long-term strategy. Currently, there are around ten new molecular entities in clinical development in this area, targeting breast and lung cancers and other solid tumours, as well as various leukaemias and lymphomas. This portfolio of innovative cancer treatments is being developed with partners worldwide, and covers different cancer hallmarks, including cytotoxics, proapoptotics, targeted, immune and cellular therapies.

1. NICE TA405. Available at: www.nice.org.uk/guidance/ta405 Accessed August 2016

2. Mayer R, et al. New England  Journal of  Medicine. 2015;372:1909-1919

3. Mayer R, et al. Journal of  Clinical  Oncology 34, 2016 (suppl 4S; abstr 634) 

4. Lonsurf SPC available at http://www.medicines.org.uk/emc/medicine/32207 Accessed August 2016

5. Cancer Drugs Fund List. Available at: https://www.england.nhs.uk/ourwork/cancer/cdf/list/ Accessed July  2016

6. Cancer Research UK. Bowel Cancer Statistics. Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bowel-cancer  Accessed August 2016 

7. Van Cutsem E, et al Annals of Oncology (2014) 25 (suppl 3): iii1-iii9.

8. FDA News Release. 22 September 2015. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm463650.htm Accessed August 2016

9. Taiho Pharma Press Release 24 March 2014. Available at: http://www.taiho.co.jp/english/news/20140324.html  Accessed August 2016

10. Taiho Pharma. Press Release 20 March 2015. Available at: http://www.taiho.co.jp/english/news/20150320.html  Accessed August 2016

11. Emura T et al. International Journal of Molecular Medicine 2004;13:545-49.

12. Lenz HJ, et al. Cancer Treatment Reviews. 2015. 41:777-783 

UK16GEN0041 DoP: August 2016

 

 

UK16WEB0010(1) DoP: March 2017