SMC Accepts Servier's Lonsurf®

Stoke Poges (UK), 13th February 2017 – Servier UK announced today that following a full submission the Scottish Medicines Consortium (SMC) has published advice accepting Lonsurf® (trifluridine/tipiracil), a treatment for metastatic colorectal cancer, for use within NHS Scotland.1

Trifluridine/tipiracil, indicated 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,2 was accepted following consideration through the SMC’s Patient and Clinician Engagement (PACE) process, a process used to review medicines intended to treat end of life and very rare conditions.1

The SMC took end-of-life considerations in to account, appraising the survival benefit with trifluridine/tipiracil in the context of the life expectancy of patients with metastatic colorectal cancer. The SMC concluded that treatment with trifluridine/tipiracil was associated with an improvement in overall survival when compared with best supportive care in patients who had received, or were intolerant of, first and second-line therapies for metastatic CRC.1 Through the PACE process, patient groups and clinicians described how other treatment options are extremely limited for this group.1,3 Trifluridine/tipiracil is an oral treatment with manageable side effects, and may offer patients an additional two months survival, which is important in the context of limited remaining time.3 The full recommendation can be found here: https://www.scottishmedicines.org.uk/files/advice/trifluridine_tipiracil_Lonsurf_FINAL_Jan_2017_for_website.pdf

Dr Janet Graham, Consultant Medical Oncologist at the Beatson West of Scotland Cancer Centre said “This is great news for patients in Scotland with mCRC. At this stage of the disease there are limited options available to patients and treatment can be a fine balance between efficacy and tolerability. The accessibility of Lonsurf for these patients with advanced colorectal cancer offers a potential choice of therapy that may extend their survival even after existing treatments have been used.”

The SMC’s acceptance of trifluridine/tipiracil follows the recommendation made by the National Institute for Health and Care Excellence (NICE) in August 2016 and means that appropriate patients living in England, Wales, Northern Ireland and Scotland now have access to treatment on the NHS.1,4

The submission to the SMC contained evidence from a large international study called the RECOURSE trial.5 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.5 In the clinical trial trifluridine/tipiracil significantly improved how long a patient survived.5,6 Patients taking trifluridine/tipiracil survived for 2 months longer than patients taking the placebo.6 The median overall survival improved from 5.2 months with placebo to 7.2 months with trifluridine/tipiracil.6 The 1 year survival rate with trifluridine/tipiracil was 27.1% vs.16.6% with placebo.6

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 (an indicator of liver impairment which may be drug or disease related), increase in alkaline phosphatase level (a liver enzyme).2,5

Servier is an international pharmaceutical company, with no shareholders and governed by a non-profit Foundation. Trifluridine/tipiracil is Servier UK’s first cancer treatment and recognition by both the SMC and NICE of the value it offers to patients with metastatic colorectal cancer reinforces the company’s commitment to research in the field of oncology.

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

Black Triangle Symbol

The black triangle symbol indicates that a product is under intensive monitoring. It is applied to new medicines because there is only limited information about safety available from clinical trials. It means that patients and prescribers should report any side effects through the Yellow Card Scheme (www.mhra.gov.uk/yellowcard).

About Metastatic Colorectal Cancer

Colorectal cancer also called bowel cancer, is the second leading cause of cancer-related deaths in the UK7 and Europe.8 In 2012, 215,000 people died from the disease across Europe8, with 16,200 (44/day) of those people being from the UK.8 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.7 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.7

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.8 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.7

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.2 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.9-11

Lonsurf is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells). It contains two active substances: trifluridine and tipiracil.2,12 In the body, trifluridine is converted into an active form that is incorporated directly into DNA, the genetic material of cells. 2,12 As a result, trifluridine interferes with DNA function and prevents the cells from dividing and multiplying.2,12 The conversion of trifluridine into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells. This results in the growth of cancer cells being reduced, while normal cells are only slightly affected. Tipiracil increases the level of trifluridine in the blood by slowing its breakdown. This therefore boosts trifluridine’s effect. 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.2,13,14

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 foundation and headquartered in Suresnes (France). With a strong international presence in 148 countries and a turnover of 4 billion euros in 2016, Servier employs 21,000 people worldwide. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular diseases, diabetes, cancers, immune-inflammatory diseases, and neurodegenerative diseases, as well as by its activities in high-quality generic drugs. Being completely independent, the Group reinvests 25% of turnover (excluding generics) in research and development and uses all its profits for growth. More information: www.servier.com

Cancers

Becoming a key player in oncology is part of Servier’s long-term strategy. Currently, there are nine molecular entities in clinical development in this area, targeting gastric and lung cancers and other solid tumors, as well as various leukemias and lymphomas. This portfolio of innovative cancer treatments is being developed with partners worldwide, and covers different cancer hallmarks and modalities, including cytotoxics, proapoptotics, targeted, immune and cellular therapies, to deliver life-changing medicines to patients.

1.SMC No. 1221/17) https://www.scottishmedicines.org.uk/files/advice/trifluridine_tipiracil_Lonsurf_FINAL_Jan_2017_for_website.pdf Accessed February 2017

2.Lonsurf SPC available at http://www.medicines.org.uk/emc/medicine/32207 Accessed February 2017

3.SMC News available at https://www.scottishmedicines.org.uk/About_SMC/Latest_news/News_Articles/February_2017_decisions_news_release Accessed February 2017

4.NICE TA405. Available at: www.nice.org.uk/guidance/TA405 Accessed February 2017

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

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

7.Cancer Research UK. Bowel Cancer Statistics. Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bowel-cancer Accessed February 2017

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

9.FDA News Release. 22 September 2015. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm463650.htm Accessed February 2017

10.Taiho Pharma Press Release 24 March 2014. Available at: http://www.taiho.co.jp/english/news/20140324.html Accessed February 2017

11.Taiho Pharma. Press Release 20 March 2015. Available at: http://www.taiho.co.jp/english/news/20150320.html Accessed February 2017

12.EPAR summary for the public. EMA/165020/2016 Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Summary_for_the_public/human/003897/WC500206249.pdf Accessed February 2017

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

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

UK17GEN0004 DoP: February 2017

 

UK17WEB0001 DoP: February 2017