Merck Healthcare

Putting the Patient First: Merck Serono to Present Data That Embodies the ESMO 2014 Theme of 'Precision Medicine in Cancer Care'

Darmstadt, Germany (ots/PRNewswire) - Not intended for US- and UK-based media

ESMO 2014 Abstract #: Physician biomarker survey: 1080O_PR; Erbitux: CRYSTAL: 541P; LASCCHN: 993PD; DIRECT: 996P; Pipeline: pimasertib: 443O; c-Met: 1333TiP, 450PD, 744TiP, 745TiP; further pipeline: 772P, 507PD, 1235P

- New research evaluates physicians' understanding of predictive biomarkers
  and perceptions of what patients themselves understand about personalized medicine
- Key data from analyses of Erbitux(R) (cetuximab) in RAS wild-type metastatic
  colorectal cancer and in human papillomavirus p16+/p16- locoregionally advanced SCCHN
  patient populations
- Pipeline data on early-stage compounds targeting specific pathways in
  difficult-to-treat cancers
 

Merck Serono, the biopharmaceutical division of Merck, today announced that it will be presenting data at the European Society for Medical Oncology (ESMO) 2014 congress (Madrid, Spain, September 26-30, 2014) aligned with the congress theme of 'Precision Medicine in Cancer Care'. 'Precision medicine', as defined by ESMO 2014, involves providing optimal treatment for patients according to their individual circumstances and the molecular characteristics of their disease.[1]

"Merck Serono believes in the principle of 'Precision Medicine'; it underpins both our patient-centric approach and our commitment to identifying those patients who would benefit most from our medicines," said Luciano Rossetti, Head of Research and Development, Merck Serono. "The data at ESMO 2014 demonstrates how we put the patient first, and go beyond treatment to support the delivery of focused cancer care, including biomarker testing."

Physician and Patient Understanding of Biomarkers

Findings from a Merck Serono-sponsored global survey of oncologists (n=895)[2] from 12 countries (across Asia, Europe and South America) on their use of predictive biomarkers in a range of late-stage and metastatic cancers (lung, breast and colorectal [mCRC]) will be presented during an oral session on Sunday, September 28, 11:00-12:20. The survey also includes physician perceptions of patient understanding of biomarkers and treatment options.

Results from the survey will also be included in an official ESMO 2014 press release and are under strict embargo until 11:00 CET on Sunday, September 28, 2014.

Exploring Biomarkers in mCRC and SCCHN

Retrospective subanalyses from two pivotal Phase III studies for Erbitux(R) (cetuximab) will be presented as part of Merck Serono's continued effort to further understand biomarkers that may help to inform treatment decisions. The CRYSTAL* study subanalysis evaluates Erbitux plus FOLFIRI (folinic acid, 5-fluorouracil and irinotecan), compared with FOLFIRI alone, in patients with RAS wild-type mCRC, as assessed by liver-limited disease (LLD) status. Further data from the Bonner study assesses the prognostic value of p16 status (p16 positive and p16 negative), a marker of human papillomavirus, in patients with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN).

Pipeline Data: Targeting Specific Pathways

Merck Serono is presenting data from its diversified early-stage pipeline at ESMO 2014, underscoring the importance of targeting specific pathways. Data include results in difficult-to-treat cancers, as well as in specific patient populations. Highlights include: an oral presentation on results from a Phase Ib study of pimasertib, a MEK inhibitor, in selected genotype-defined solid tumors; pimasertib in combination with SAR245409, a PI3K/MTOR inhibitor; and a number of studies of the highly selective c-Met inhibitor MSC2156119J (EMD 1214063), including a poster discussion of the first-in-human Phase I results in patients with advanced solid tumors. Data will also be presented on abituzumab (DI17E6, EMD 525797) an investigational anti-integrin monoclonal antibody.

Notes to Editors

Abstracts related to Merck Serono studies with Erbitux and pipeline compounds include:

Erbitux

Title: FOLFIRI plus cetuximab in patients liver-limited or non-liver-limited RAS
 wild-type metastatic disease: A sub-group analysis of the CRYSTAL study
Lead author: C-H Köhne
Abstract #: 541P
Presentation date/time (CET): Sep 29, 12:45-13:45
Session: Poster Display Session
Room/details: Poster display area

Title: Association of human papillomavirus (HPV) and p16 status with efficacy and
 safety data in the Phase III radiotherapy (RT)/cetuximab (cet) registration trial for
 locoregionally advanced squamous cell carcinoma of the head and neck (LASCCHN)
Lead author: JA Bonner
Abstract #: 993PD
Presentation date/time (CET): Sep 28, 13:00-14:00
Session: Poster Discussion, Head and Neck Cancer
Room/details: Bilbao

Title: Cetuximab relative dose intensity (RDI) in recurrent/metastatic (R/M) squamous
 cell carcinoma of the head and neck (SCCHN): First observational prospective study in
 unselected patients (DIRECT trial)
Lead author: J Guigay
Abstract #: 996P
Presentation date/time (CET): Sep 29, 12:45-13:45
Session: Poster Display Session
Room/details: Poster display area

General oncology: Physician biomarker survey

Title: Physicians' awareness and understanding of personalized medicine in the
 treatment of cancer and its adoption in clinical practice: a multinational survey
Lead author: F Ciardiello
Abstract #: 1080O_PR
Presentation date/time (CET): Sep 28, 11:00-12:20
Session: Proffered Papers, Issues Facing Oncologists Today
Room/details: Alicante

c-Met inhibitor, MSC2156119J

Title: Phase Ib/II trial of c-Met inhibitor MSC2156119J and gefitinib vs chemotherapy
 as 2nd-line treatment in Asian patients with Met-positive (Met+), locally advanced or
 metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor mutation
 (EGFRm+) and progression on gefitinib
Lead author: K Park
Abstract #: 1333TiP
Presentation date/time (CET): Sep 27, 12:45-13:45
Session: Poster Display Session
Room/details: Poster display area

Title: First-in-human Phase I trial assessing the highly selective c-Met inhibitor
 MSC2156119J (EMD 1214063) in patients with advanced solid tumors
Lead author: GS Falchook
Abstract #: 450PD
Presentation date/time (CET): Sep 28, 13:00-14:00
Session: Poster Discussion Session, Developmental Therapeutics
Room/details: Alicante

Title: Met-positive advanced hepatocellular carcinoma and Child-Pugh class A liver
 function in Asian patients: a randomized, multicenter, Phase Ib/II trial of the oral
 c-Met inhibitor MSC2156119J vs sorafenib
Lead author: S Qin
Abstract #: 744TiP
Presentation date/time (CET): Sep 29, 12:45-13:45
Session: Poster Display Session
Room/details: Poster display area

Title: Phase Ib/II, multicenter, single-arm trial of the oral c-Met inhibitor
 MSC2156119J as monotherapy in patients with Met-positive advanced hepatocellular
 carcinoma with Child-Pugh class A liver function who failed sorafenib treatment
Lead author: S Faivre
Abstract #: 745TiP
Presentation date/time (CET):
 Sep 29, 12:45-13:45
Session: Poster Display Session
Room/details: Poster display area

Pimasertib, a MEK inhibitor

Title: Pimasertib (PIM) and SAR245409 (SAR) - a MEK and PI3K/MTOR inhibitor
 combination: A Phase Ib trial with expansions in selected genotype-defined solid
 tumors
Lead author: RS Heist
Abstract #: 443O
Presentation date/time (CET): Sep 27, 14:00-15:45
Session: Proffered Papers, Developmental Therapeutics, Oral Presentation
Room/details: Cordoba

Additional Pipeline Projects: Oncology

Title: Abituzumab (DI17E6, EMD 525797) treatment for chemotherapy-naive patients with
 asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer
 (mCRPC): primary outcomes of the placebo-controlled Phase 2 study PERSEUS
 (NCT01360840)
Lead author: K Miller
Abstract #: 772P
Presentation date/time (CDT): Sep 27, 12:45-13:45
Session: Poster Display Session
Room/details: Poster display area

Title: POSEIDON Phase I/II trial: abituzumab combined with cetuximab plus irinotecan as
 second-line treatment for patients with KRAS wild-type metastatic colorectal cancer
Lead author: E Élez
Abstract #: 507PD
Presentation date/time (CDT): Sep 27, 13:00-14:00
Session: Poster Discussion Session, Gastrointestinal Tumors, Colorectal
Room/details: Granada
 

All early-stage products are currently under clinical investigation and have not been approved for use in the U.S., Europe, Canada, or elsewhere. All investigational products have not yet been proven to be either safe or effective and any claims of safety and effectiveness can be made only after regulatory review of the data and approval of the labeled claims.

*CRYSTAL: Cetuximab combined with iRinotecan in first-line therapY for metaSTatic colorectAL cancer

References

1) European Society for Medical Oncology 2014 Congress Page. Available at:
  http://www.esmo.org/Conferences/ESMO-2014-Congress/Programme. Last accessed
  September 2014.
2) Ciardiello, F et al. Oral presentation at the European Society for Medical
  Oncology Congress, 2014, September 28. Abstract No:1080O_PR.
 

For more information on Merck Serono in oncology and immuno-oncology, please visit: http://www.globalcancernews.com.

About Erbitux

Erbitux(R) is a first-in-class and 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 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. In Japan, ImClone, Bristol-Myers Squibb Company and Merck jointly develop and commercialize Erbitux. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas.

About Merck Serono

Merck Serono is the biopharmaceutical division of Merck. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.

Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology.

For more information, please visit http://www.merckserono.com.

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Merck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. With its four divisions Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck generated total revenues of EUR 11.1 billion in 2013. Around 39,000 Merck employees work in 66 countries to improve the quality of life for patients, to further the success of our customers and to help meet global challenges.

Merck is the world's oldest pharmaceutical and chemical company - since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70% interest, the founding family remains the majority owner of the company to this day.

Merck, Darmstadt, Germany is holding the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company is known as EMD.

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