NICE Expands Positive Recommendation for Erbitux as First-line Treatment for RAS Wild-type mCRC

DARMSTADT, Germany, March 2, 2017 /PRNewswire/ --

Not intended for UK- or US-based media  

• More patients now able to receive a standard-of-care treatment with Erbitux plus FOLFIRI or FOLFOX 
• NICE's recommendation is a significant step forward in Merck's aspiration to ensure cancer patients have optimal access to effective treatments worldwide 

Merck, a leading science and technology company, announced today that the UK National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Determination (FAD) recommending the routine National Health Service (NHS) use of Erbitux^® (cetuximab) in combination with either FOLFIRI or FOLFOX as a first-line treatment for patients with RAS wild-type metastatic colorectal cancer (mCRC). Erbitux has long been established and reimbursed as a first-line standard-of-care treatment option in most European countries and many other countries worldwide.

"The NICE decision is great news for patients and their families in England, as it now means they will have access to this effective first-line treatment," said Maya Martinez-Davis, Global Head of Oncology Franchise for Merck's biopharma business. "Our efforts in working with NICE to reach this important milestone are part of our relentless commitment to bringing tailored, effective therapies to patients worldwide."

This decision expands the previous NICE recommendation,^[1] which endorsed the use of Erbitux in combination with either FOLFOX or FOLFIRI solely for patients whose cancer had spread only to the liver (liver-limited disease). It is based on robust data from Phase III clinical studies having demonstrated that Erbitux in combination with either FOLFIRI^[2],[3],[4] or FOLFOX,^[2],[5],[6] as a first-line treatment for patients with RAS
wild-type mCRC, confers significant benefit in patient outcomes.

"Patients with metastatic colorectal cancer in the UK have very limited access to effective first-line treatments," said Jola Gore-Booth, Founder/CEO of the colorectal cancer patient advocacy group, EuropaColon. "We are therefore delighted with NICE's decision, as it means there is now more choice for patients in England regarding treatment options that they can benefit from."

Both the European Society for Medical Oncology and the US National Comprehensive Cancer Network clinical guidelines also recommend first-line treatment with Erbitux, in combination with either FOLFOX or FOLFIRI, for patients with RAS wild-type mCRC.^[7],[8]

Erbitux has obtained marketing authorization in over 90 countries worldwide. To date, more than 480,000 patients with mCRC have been treated with Erbitux.

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About the NICE process 

By publishing a Final Appraisal Determination (FAD), the National Institute for Health and Care Excellence (NICE) has made final recommendations on how Erbitux with FOLFOX/FOLFIRI should be used in the NHS. If there are no successful appeals, the final recommendations will be issued as NICE guidance.

About mCRC 

Approximately half of patients with mCRC have RAS wild-type tumors and half have RAS mutant tumors.^[9] Results from studies assessing RAS mutation status in patients with mCRC have shown that anti-epidermal growth factor receptor (EGFR) monoclonal antibody therapies, such as Erbitux^® (cetuximab), can improve outcomes in patients with RAS wild-type mCRC.^[2]-[6] Colorectal cancer (CRC) is the third most common cancer worldwide, with an estimated incidence of more than 1.36 million new cases annually.^[10] An estimated 694,000 deaths from CRC occur worldwide every year, accounting for 8.5% of all cancer deaths and making it the fourth most common cause of death from cancer.^[10] Almost 55% of CRC cases are diagnosed in developed regions of the world, and incidence and mortality rates are substantially higher in men than in women.^[10]

About Erbitux 

Erbitux^® is a highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth.

The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.

Erbitux has already obtained market authorization in over 90 countries world-wide for the treatment of colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck (SCCHN). Merck licensed the right to market Erbitux outside the US and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

About Merck 

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2015, Merck generated sales of €12.85 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

References

1. National Institute for Health and Care Excellence. Cetuximab for the first-line treatment of metastatic colorectal cancer: TA176. Available from: https://www.nice.org.uk/guidance/TA176/chapter/1-Guidance. Accessed February 2017.
2. Lenz H et al. Ann Oncol 2014;25(Suppl 5):v1-41.
3. Van Cutsem E et al. J Clin Oncol 2015;33(7):692-700.
4. Stintzing S et al. Oral presentation at the 2014 European Society for Medical Oncology Congress, September 26-30, 2014. Abstract No:LBA11.
5. Bokemeyer C et al. J Clin Oncol 2014;32:(Suppl 4): abstr 3505.
6. Qin S, et al. Ann Oncol 2016;27(suppl 4):0-025.
7. Van Cutsem E et al. Ann Oncol 2014;25(Suppl 3):iii 1-9.
8. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology (NCCN Guidelines). Colon Cancer. Version 2.2016. Available from: http://www.nccn.org/patients. Accessed February 2017.
9. Vaughn CP et al. Genes Chromosomes Cancer 2011;50(5):307−12.
10. Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer. 2013. Available from: http://globocan.iarc.fr. Accessed February 2017.

SOURCE Merck KGaA

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