Results of Pivotal TAILOR Study Confirm Addition of Erbitux to FOLFOX Significantly Improves Outcomes in RAS Wild-Type Metastatic Colorectal Cancer

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DARMSTADT, Germany, July 1, 2016 /PRNewswire=KYODO JBN/--

    Not intended for UK- or US-based media

    WCGC Abstract #

    0-025; poster presentation, July 1, 2016, 10:35 am CEST

    Phase III study shows response rate of 61.1% for patients treated with

Erbitux plus FOLFOX

31% decrease in risk of disease progression and 24% decrease in risk of death

was achieved with addition of Erbitux to FOLFOX  

    First prospective study to evaluate Erbitux in RAS wild-type patients

Merck, a leading science and technology company, will present data at the ESMO

18th World Congress on Gastrointestinal Cancer (WCGC) from the pivotal Phase

III TAILOR study in patients from China, the first prospective trial to

evaluate an anti-EGFR antibody in the first-line therapy of patients with RAS

wild-type metastatic colorectal cancer (mCRC). The results demonstrate that

Erbitux(R) (cetuximab) plus FOLFOX statistically significantly improves outcomes,

including progression-free survival (PFS; primary endpoint), overall survival

(OS) and best overall response rate (bORR), compared with FOLFOX alone.[1]

    Notably, compared with those receiving FOLFOX alone, patients in the study

receiving Erbitux plus FOLFOX experienced:[1]

    -a bORR of 61.1% (versus 39.5%; odds ratio [OR]: 2.41; p＜0.001), which is

in line with international studies

    -a 31% decrease in the risk of disease progression (hazard ratio [HR]:

0.69; p=0.004); and,

    -a 24% reduction in the risk of death (HR: 0.76; p=0.02).

    "As a standard-of-care treatment, Erbitux is a strategic priority product

for Merck and our aspiration is that patients have optimal access to this drug

worldwide," said Luciano Rossetti, Executive Vice President, Global Head of

Research & Development in the biopharma business of Merck. "We are confident

the TAILOR results form a good basis upon which approval could be extended to

first-line metastatic colorectal cancer treatment in China."

    The TAILOR study randomized 393 patients from China with RAS wild-type

mCRC, and the results demonstrate that adding Erbitux to FOLFOX, as a

first-line treatment, significantly improves PFS (median PFS: 9.2 vs 7.4

months) and OS (median OS: 20.7 vs 17.8 months). The safety profile of Erbitux

observed in TAILOR is similar to that seen in prior randomized clinical trials,

with no unexpected safety findings.[1]

    "The results of the TAILOR study further reaffirm that Erbitux plus FOLFOX

as chemotherapy backbone is an effective treatment regimen for patients with

RAS wild-type mCRC, as we have seen in previous international pivotal studies,

such as OPUS," said Prof. Carsten Bokemeyer, University Medical Center,

Hamburg-Eppendorf, Germany and primary investigator of the OPUS study. "As the

first prospective trial evaluating Erbitux in RAS wild-type patients, the

TAILOR results reinforce the value and importance of RAS biomarker testing in

order to determine the appropriate targeted therapy for individual patients,

based on their tumor's genetic make-up."  

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

Society for Medical Oncology clinical guidelines recommend first-line treatment

with Erbitux plus either FOLFOX or FOLFIRI for patients with RAS wild-type

mCRC.[3],[4]

    "There are currently limited first-line options available in China for

patients with RAS wild-type metastatic colorectal cancer," said Professor

Shukui Qin from Nanjing Bayi Hospital, China, Coordinating Investigator in the

TAILOR study. "The results of the TAILOR study strongly support the benefit of

Erbitux in the treatment of these patients, and we are hopeful it will soon be

approved so that patients in this country will be able to access treatment

options that they so desperately need."

    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).[3-5] More than 442,000 patients with mCRC have been

treated with Erbitux.

    For further information and press materials please visit

http://www.merckgroup.com/media-center-oncology.

    References

1.Qin S, et al. Ann Oncol 2016;27(Suppl 4):0-025.

2.Bokemeyer C et al. J Clin Oncol 2014;25:(Suppl 2):ii 105-17

3.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

June 2016.

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

5.Erbitux(R) (cetuximab) SmPC, Last updated June 2014. Available at:

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

Accessed June 2016.

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

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

8.Stintzing S et al. Oral presentation at the 2014 European Society for Medical

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

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

10.Ferlay J, et al. Int J Cancer 2015;136:E359-86.

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    About the TAILOR study  

    The TAILOR study is a prospective, 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 patients in China

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 PFS. Secondary endpoints include: OS, best ORR, 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.[6] 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.[2],[7]-[9] 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(R) is a highly active IgG1 monoclonal antibody targeting 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.

    About Merck

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therapies to treat cancer or multiple sclerosis, cutting-edge systems for

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