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Cornelia Bartels
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September 26, 2014 Not intended for US- and UK-based mediaESMO 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
Putting the Patient First: Merck Serono to Present Data That Embodies the ESMO 2014 Theme of 'Precision Medicine in Cancer Care'• New research evaluates physicians' understanding of predictive biomarkers and perceptions of what patients themselves understand about personalized medicine
• Key data from analyses of Erbitux® (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
Darmstadt, Germany, September 26, 2014 - 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
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Hotline +49 (0) 6151 72-5000 http://www.merckgroup.com/www.merckgroup.com
Tel. +49 (0) 6151 72-3890 cornelia.bartels@merckgroup.com
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 BiomarkersFindings 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 SCCHNRetrospective subanalyses from two pivotal Phase III studies for Erbitux® (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).
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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 EditorsAbstracts related to Merck Serono studies with Erbitux and pipeline compounds include:
Title | Lead author | Abstract # | Presentation date/time (CET) | Session | Room/ details |
Erbitux | |||||
FOLFIRI plus cetuximab in patients liver-limited or non- liver-limited RAS wild-type metastatic disease: A sub- group analysis of the CRYSTAL study | C-H Köhne | 541P | Sep 29, 12:45-13:45 | Poster Display Session | Poster display area |
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) | JA Bonner | 993PD | Sep 28, 13:00-14:00 | Poster Discussion, Head and Neck Cancer | Bilbao |
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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) | J Guigay | 996P | Sep 29, 12:45-13:45 | Poster Display Session | Poster display area |
Title | Lead author | Abstract # | Presentation date/time (CET) | Session | Room/ details |
General oncology: Physician biomarker survey | |||||
Physicians' awareness and understanding of personalized medicine in the treatment of cancer and its adoption in clinical practice: a multinational survey | F Ciardiello | 1080O_P R | Sep 28, 11:00-12:20 | Proffered Papers, Issues Facing Oncologists Today | Alicante |
Title | Lead author | Abstract # | Presentation date/time (CET) | Session | Room/ details |
c-Met inhibitor, MSC2156119J | |||||
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 | K Park | 1333TiP | Sep 27, 12:45-13:45 | Poster Display Session | Poster display area |
First-in-human Phase I trial assessing the highly selective c-Met inhibitor MSC2156119J (EMD 1214063) in patients with advanced solid tumors | GS Falchook | 450PD | Sep 28, 13:00-14:00 | Poster Discussion Session, Development al Therapeutics | Alicante |
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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 | S Qin | 744TiP | Sep 29, 12:45-13:45 | Poster Display Session | Poster display area |
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 | S Faivre | 745TiP | Sep 29, 12:45-13:45 | Poster Display Session | Poster display area |
Pimasertib, a MEK inhibitor | |||||
Pimasertib (PIM) and SAR245409 (SAR) - a MEK and PI3K/MTOR inhibitor combination: A Phase Ib trial with expansions in selected genotype-defined solid tumors | RS Heist | 443O | Sep 27, 14:00-15:45 | Proffered Papers, Development al Therapeutics , Oral Presentation | Cordoba |
Title | Lead author | Abstract # | Presentation date/time (CDT) | Session | Room/ details |
Additional Pipeline Projects: Oncology | |||||
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) | K Miller | 772P | Sep 27, 12:45-13:45 | Poster Display Session | Poster display area |
POSEIDON Phase I/II trial: abituzumab combined with cetuximab plus irinotecan as second-line treatment for patients with KRAS wild-type metastatic colorectal cancer | E Élez | 507PD | Sep 27, 13:00-14:00 | Poster Discussion Session, Gastrointestin al Tumors, Colorectal | Granada |
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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.
3. Tejpar, S et al. Oral presentation at the European Society for Medical Oncology Congress, 2012, September 29. Abstract No:1634.
For more information on Merck Serono in oncology and immuno-oncology, please visit:
www.globalcancernews.com.
About Erbitux
Erbitux® 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.
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/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 € 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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