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

Darmstadt, Germany (ots/PRNewswire) -

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®
(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-naïve 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® (cetuximab) SmPC, Last updated June 2014. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Produ
ct_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® (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® 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

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 EUR 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.

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