Download New Treatment for Patients with Refractory Metastatic Colorectal

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New Treatment for Patients with Refractory Metastatic Colorectal Cancer:
NICE recommends Servier’s Lonsurf®▼ (trifluridine/tipiracil)1
Wexham (UK), 24th August 2016 – Servier UK today announced that, following a single technology appraisal,
the National Institute for Health and Care Excellence (NICE) has issued final guidance recommending Lonsurf®
(trifluridine/tipiracil), within its marketing authorisation, as an option for treating metastatic colorectal cancer,
in adults who have had previous treatment with available therapies including fluoropyrimidine-, oxaliplatin- or
irinotecan-based chemotherapies, anti-vascular endothelial growth factor (VEGF) agents and anti-epidermal
growth factor receptor (EGFR) agents, or when these therapies are not suitable.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. With 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 oncology product. The recommendation 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, agreeing that trifluridine/tipiracil met the
criterion for extending life.1 NICE therefore appraised the survival benefit with trifluridine/tipiracil in the
context of the life expectancy of patients with metastatic colorectal cancer.1 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 the international, doubleblind, placebo-controlled Phase III RECOURSE study, which investigated the efficacy and safety of
trifluridine/tipiracil plus best supportive care (BSC) compared to placebo plus BSC in 800 patients with
previously treated mCRC.2 The trial met the primary endpoint of a statistically significant improvement in
overall survival (OS).2 The median OS improved from 5.2 months with placebo (+BSC) to 7.2 months with
trifluridine/tipiracil (+BSC).3 The hazard ratio for death in the trifluridine/tipiracil group versus the placebo
group was 0.69 (95% confidence interval [CI], 0.59 to 0.81; P<0.0001), this translated into 1-year survival rates
of 27.1% and 16.6%, respectively.3
The most frequently observed side effects (≥ 30%) in patients receiving trifluridine/tipiracil were neutropenia,
nausea, decreased appetite, diarrhoea, fatigue, anaemia, thrombocytopenia, increase in total bilirubin,
alkaline phosphatase and AST levels, and leucopenia.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 any
delays in appropriate patients receiving this new treatment.5
ENDS
Code: UK16GEN0040
Date of Preparation: August 2016
FOR MEDICAL PRESS & PHARMACEUTICAL TRADE PRESS ONLY
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety
information. Health professionals are asked to report any suspected adverse drug reactions.
See www.mhra.gov.uk/yellowcard for how to report side effects.
Servier UK Media Contact:
Tel: +44 (0) 1753 662744
Servier UK Medical Information: Tel: +44 (0) 1753 666409
Email: [email protected]
Email: [email protected]
Notes to Editor
About Metastatic Colorectal Cancer
6
7
Colorectal cancer, is the second leading cause of cancer-related deaths in the UK and Europe. In 2012, 215,000 people
7
7
died from the disease across Europe , with 16,200 (44/day) of those people being from the UK. 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
6
day. Colorectal cancer is the fourth most common cancer in the UK (2013), with 1 in 14 men and 1 in 19 women
6
diagnosed with colorectal cancer during their lifetime.
Approximately 25% of patients with colorectal cancer present with metastases at initial diagnosis and almost 50% of
patients with colorectal their disease for five years or more, compared with fewer than 1 in 10 people when diagnosed at
6
the latest stage.
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
4
fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.
Trifluridine/tipiracil is currently available in Japan for the treatment of unresectable advanced or recurrent colorectal 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 wild8-10
type, an anti-EGFR therapy.
Trifluridine/tipiracil is an oral anticancer drug, comprising the combination of trifluridine
(FTD) and tipiracil (TPI), whose dual mechanism of action is designed to maintain clinical activity and differs from
4,11,12
fluoropyrimidines.
FTD is an antineoplastic nucleoside analogue, which is incorporated directly into the DNA, thereby
4, 11, 12
interfering with the function of DNA.
The blood concentration of FTD is maintained via TPI, which is an inhibitor of
4,12
the FTD-degrading enzyme, thymidine phosphorylase.
In June 2015, Servier entered into an exclusive license agreement with Taiho Pharmaceutical Co., Ltd. for the codevelopment and commercialisation 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 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.
Code: UK16GEN0040
Date of Preparation: August 2016
FOR MEDICAL PRESS & PHARMACEUTICAL TRADE PRESS ONLY
1.
2.
3.
4.
5.
6.
NICE TA405. Available at: www.nice.org.uk/guidance/ta405 Accessed August 2016
Mayer R, et al. New England Journal of Medicine. 2015;372:1909-1919
Mayer R, et al. Journal of Clinical Oncology 34, 2016 (suppl 4S; abstr 634)
Lonsurf SPC available at http://www.medicines.org.uk/emc/medicine/32207 Accessed August 2016
Cancer Drugs Fund List. Available at: https://www.england.nhs.uk/ourwork/cancer/cdf/list/ Accessed August 2016
Cancer Research UK. Bowel Cancer Statistics. Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statisticsby-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
Code: UK16GEN0040
Date of Preparation: August 2016