DARMSTADT, Germany,
July 1, 2016 /CNW/ -
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
- Qin S, et al. Ann Oncol 2016;27(Suppl 4):0-025.
- Bokemeyer C et al. J Clin Oncol 2014;25:(Suppl 2):ii
105-17
- 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.
- Van Cutsem E et al. Ann Oncol 2014;25(Suppl 3):iii 1-9.
- Erbitux® (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.
- Vaughn CP et al. Genes Chromosomes Cancer
2011;50(5):307−12.
- Van Cutsem E et al. J Clin Oncol 2015;33(7):692-700.
- Stintzing S et al. Oral presentation at the 2014 European
Society for Medical Oncology Congress, September 26-30, 2014. Abstract No:LBA11.
- Lenz H et al. Ann Oncol 2014;25(Suppl 5):v1-41.
- Ferlay J, et al. Int J Cancer 2015;136:E359-86.
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 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 € 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.
(Logo:
http://photos.prnewswire.com/prnh/20151207/293543LOGO )
SOURCE Merck