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

DARMSTADT, Germany, April 25, 2016 /PRNewswire/ --

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

"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-naïve 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^® (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^® 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 €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. 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® (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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