Phase III TAILOR Landmark Study Demonstrates Significant Benefits of Erbitux in Combination with FOLFOX Over FOLFOX Alone

PR64209

DARMSTADT, Germany, Apr. 25, 2016 /PRNewswire=KYODO JBN/ --

Not intended for UK- or US-based media

- Chinese pivotal Phase III study meets its primary endpoint of increased       

progression-free survival in first-line treatment of patients with RAS

wild-type       metastatic colorectal cancer     

- Merck will work with relevant authorities to make Erbitux available for

patients in China as a first-line treatment as soon as possible     

- This marks a major milestone of Merck's oncology strategy including expansion

in growth markets

Merck, a leading science and technology company, today announced that the

pivotal Chinese Phase III TAILOR study met its primary endpoint of

significantly increasing progression-free survival (PFS) in patients with RAS

wild-type metastatic colorectal cancer (mCRC) treated with Erbitux(R)

(cetuximab) plus FOLFOX chemotherapy, compared with FOLFOX alone.

(Logo: http://photos.prnewswire.com/prnh/20151207/293543LOGO )

"We are thrilled with the TAILOR results that bring a major contribution to the

available scientific evidence of Erbitux's efficacy in combination with FOLFOX

as a standard first-line treatment for patients with RAS wild-type metastatic

colorectal cancer. This marks a significant step in the execution of our

strategy in oncology, notably the expansion in growth markets like China," said

Luciano Rossetti, Head of Global Research and Development of Merck's biopharma

business. "These impressive results reinforce the value and imperative of RAS

biomarker testing in clinical practice, so as to provide patients with the

right targeted therapy. These results also underscore why we continue to devote

our efforts towards both improving testing and ensuring access to Erbitux

worldwide." 1-4

The clinical benefit that Erbitux offers to RAS wild-type mCRC patients is

further strengthened by the secondary endpoint results, which support the

superiority shown for PFS. The safety profile of Erbitux in the TAILOR clinical

trial was manageable and similar to that observed in other pivotal trials, with

no unexpected safety findings. The full study results will be submitted to

upcoming international scientific meetings.

Both the National Comprehensive Cancer Network (U.S.) and the European Society

for Medical Oncology clinical guidelines recommend first-line treatment with

Erbitux plus FOLFOX or FOLFIRI for patients with RAS wild-type mCRC. 5,6

"We are excited that the TAILOR study is positive and that Erbitux in

combination with chemotherapy could become a new first-line treatment option

for metastatic colorectal cancer patients in China, once approved," said

Professor Shukui Qin from Nanjing Bayi Hospital, China, Coordinating

Investigator in the TAILOR study. "It is also reassuring that the results

reflect those previously observed, and support the indicated first-line use of

Erbitux plus FOLFOX in many countries."

Erbitux has obtained marketing authorization in over 90 countries worldwide. In

Europe,  Erbitux is indicated as first-line therapy for patients with RAS

wild-type mCRC tumors, together with the oxaliplatin-containing regimen FOLFOX

in treatment-naive patients or together with regimens containing irinotecan

(e.g. FOLFIRI).7 More than 442,000 patients with mCRC have been treated with

Erbitux.

About the TAILOR study

The TAILOR study is a Phase III, open-label, randomized, controlled,

multicenter trial designed to compare Erbitux in combination with FOLFOX-4

versus FOLFOX-4 alone in the first-line treatment of Chinese patients with RAS

wild-type mCRC. All randomized subjects were planned to receive treatment until

the occurrence of progressive disease (PD) or unacceptable toxicity. The study

enrolled 397 patients with RAS wild-type mCRC. The primary endpoint of the

trial is progression-free survival. Secondary endpoints include: overall

survival, best overall response rate, time to treatment failure and rate of

curative surgery for liver metastases.

About mCRC

Approximately half of patients with mCRC have RAS wild-type tumors and half

have RAS mutant tumors.8 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(R) (cetuximab), can improve

outcomes in patients with RAS wild-type mCRC. 1-4 Colorectal cancer (CRC) is

the third most common cancer worldwide, with an estimated incidence of more

than 1.36 million new cases annually.9 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.9 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.9

About Erbitux

Erbitux(R) 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.

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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 EUR12.85 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) Bokemeyer C et al. J Clin Oncol 2014;32:(Suppl 4): abstr 3505.     

2) Van Cutsem E et al. J Clin Oncol 2015;33(7):692-700.     

3) Stintzing S et al. Oral presentation at the 2014 European Society for

Medical Oncology Congress, September 26-30, 2014. Abstract No:LBA11.     

4) Lenz H et al. Ann Oncol 2014;25(Suppl 5):v1-41.     

5) 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 April 2016.     

6) Van Cutsem E et al. Ann Oncol 2014;25(Suppl 3):iii 1-9.     

7) Erbitux(R) (cetuximab) SmPC, Last updated Jun 2014. Available at:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000558/WC500029119.pdf.

Accessed April 2016.     

8) Vaughn CP et al. Genes Chromosomes Cancer 2011;50(5):307-12.     

9) 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 April 2016.

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