Merck to Present New Data at the European Cancer Congress 2015 Reinforcing the Company's Patient-Centric Focus

DARMSTADT, Germany, September 11, 2015 /PRNewswire/ --

ECC Abstract #: Avelumab*: 3090, 2749, 2364, 2630, 3110, 2398; Erbitux: 2120, 2112, 420, 2400, 2820; evofosfamide: 2312; tepotinib: 365, 2353, 3082, 369.

• Merck will share data from its priority oncology and immuno-oncology pipeline compounds, including avelumab*, evofosfamide and tepotinib  
• New Erbitux subanalysis data from multiple studies in colorectal and head and neck cancers will also be featured  

Merck will present new data on early- and late-stage compounds from its refocused oncology and immuno-oncology pipeline, as well as Erbitux^® (cetuximab) data, at this year's European Cancer Congress (ECC), held in Vienna, Austria, from September 25-29, 2015.

These data reinforce the company's science-driven and patient-centric approach to developing new therapies that will help patients fight difficult-to-treat cancers such as pancreatic, non-small cell lung and urothelial."Our data at ECC 2015 demonstrate our oncology strategy in action, through external innovation and a focus on precision medicine to personalize treatment," said Luciano Rossetti, Head of Global Research & Development at Merck's biopharmaceutical business Merck Serono. "We are committed to understanding which patients will benefit most from our treatments, as this is a critical component to improve patient outcomes."

Collaborating to Address Patient Needs  

Two important strategic collaborations presenting data in challenging cancers at ECC this year are the Merck-Pfizer Alliance, and Merck's partnership with Threshold Pharmaceuticals, Inc.

The Merck-Pfizer Alliance will present six abstracts on studies evaluating the potential role of PD-L1 inhibition, and the safety and efficacy of the investigational cancer immunotherapy avelumab. New data on this immune checkpoint inhibitor will be presented in urothelial (e.g. bladder), mesothelioma and gastric/gastroesophageal cancers. Additional non-small cell lung and ovarian cancer data from Phase Ib trials build on those previously presented at the 2015 Annual Meeting of the American Society of Clinical Oncology.^[1-10]

Together with Threshold Pharmaceuticals Inc., Merck will present Phase I study data on evofosfamide (previously known as TH-302; an investigational hypoxia-activated prodrug) in Asian patients with advanced solid tumors and pancreatic cancer. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to evofosfamide, administered in combination with gemcitabine for the treatment of previously untreated patients with locally advanced unresectable or metastatic pancreatic cancer, and for the development of evofosfamide in combination with doxorubicin for the treatment of patients with locally advanced or metastatic soft tissue sarcomas.

Personalizing Treatment for Patients   

Data presented at ECC this year will also highlight Merck's focus on precision medicine with the aim to deliver personalized treatments for patients. This includes data for tepotinib, a selective small-molecule inhibitor of the c-Met receptor tyrosine kinase, in patients with advanced hepatocellular and non-small cell lung cancer that overexpress c-Met. In addition, new subanalyses on the clinical value of Erbitux in the treatment of 1st line RAS wild-type metastatic colorectal cancer (mCRC), and of biomarkers in head and neck cancer will also be presented.

Cutting-Edge Diagnostics to Ensure Appropriate Treatment  

Merck's precision medicine research extends beyond treatment into collaborations to aid in the development of cutting-edge diagnostic tests that help physicians rapidly identify patients that will most likely benefit from specific treatments. Merck is collaborating with Sysmex Inostics on the development and commercialization of a liquid biopsy test for determining the RAS (KRAS and NRAS) tumor mutation status in mCRC patients. Sysmex will present data on the validity of the test, also referred to as a blood-based biomarker test, at ECC. The liquid biopsy RAS biomarker test is expected to receive its European Conformity approval (CE mark) this year. Currently it is applied for research use only (RUO) in a number of countries.

*Avelumab is the proposed International Nonproprietary Name (INN) for the anti-PD-L1 monoclonal antibody (MSB0010718C).

Notes to Editors  

Accepted abstracts submitted by Merck and partners related to our products, our oncology and immuno-oncology pipeline are listed below. Abstracts are currently available on the ECC website.

Erbitux  

Tumor Type: Metastatic Colorectal
Title: Quality of life analysis in patients with RAS wild-type metastatic colorectal cancer treated with first-line FOLFIRI + cetuximab in the CRYSTAL study
Lead author: Yamaguchi K
Abstract #: 2120
Presentation date/time (CET): September 27, 09:15-11:15
Session: Poster Session: Gastrointestinal Malignancies - Colorectal Cancer (P#110)
Room/details: Hall C

Tumor Type: Metastatic Colorectal
Title: Association between early tumour shrinkage and outcomes in RAS-wild type patients with metastatic colorectal cancer receiving first-line FOLFOX or FOLFIRI + cetuximab once every 2 weeks in the APEC study
Lead author: Cheng A L
Abstract #: 2112
Presentation date/time (CET): September 27, 09:15-11:15
Session: Poster Session: Gastrointestinal Malignancies -Colorectal Cancer (P#102)
Room/details: Hall C

Tumor Type: Metastatic Colorectal
Title: Flash RAS study: RAS testing assessment in patients with metastatic colorectal cancer in 2014
Lead author: Lièvre A
Abstract #: 420
Presentation date/time (CET): September 26, 16:45-18:45
Session: Poster Session: Diagnostic/Biomarkers (P#070)
Room/details: Hall C

Tumor Type: Esophageal Squamous Cell Carcinoma
Title: Biomarkers of benefit from cetuximab-based therapy in patient-derived esophageal squamous cell carcinoma xenograft models
Lead author: Wong A
Abstract #: 2400
Presentation date/time (CET): September 28, 09:15-11:15
Session: Poster Session: Gastrointestinal Malignancies - Noncolorectal Cancer (P#362)
Room/details: Hall C

Tumor Type: Squamous Cell Cancer - Head and Neck
Title: Association of p16 status and feeding tube use in patients with locoregionally advanced squamous cell cancer of the head and neck treated with radiotherapy +/- cetuximab in a Phase III study
Lead author: Bonner JA
Abstract #: 2820
Presentation date/time (CET): September 27, 09:15-11:15
Session: Poster Session: Head and Neck Cancer (P#203)
Room/details: Hall C

Avelumab  

Tumor Type: Metastatic/Recurrent Non-Small Cell Lung Cancer
Title: Avelumab (MSB0010718C), an anti-PD-L1 antibody, in patients with metastatic or recurrent non-small cell lung cancer progressing after platinum-based chemotherapy: a Phase Ib trial
Lead author: Gulley JL
Abstract #: 3090
Presentation date/time (CET): September 27, 09:15-11:15
Session: Poster Session: Lung Cancer - Metastatic Disease (P#342)
Room/details: Hall C

Tumor Type: Ovarian
Title: Avelumab (MSB0010718C), an anti-PD-L1 antibody, in patients with recurrent or refractory ovarian cancer: a Phase Ib trial reporting safety and clinical activity
Lead author: Disis M
Abstract #: 2749
Presentation date/time (CET): September 28, 09:15-11:15
Session: Poster Session: Gynaecological Cancer (P#412)
Room/details: Hall C

Tumor Type: Advanced Gastric or Gastroesophageal
Title: Avelumab (MSB0010718C), an anti-PD-L1 antibody, in patients with advanced gastric or gastroesophageal junction cancer: a Phase Ib trial
Lead author: Chung HC
Abstract #: 2364
Presentation date/time (CET): September 28, 09:15-11:15
Session: Poster Session: Gastrointestinal Malignancies - Noncolorectal Cancer (P#326)
Room/details: Hall C

Tumor Type: Locally Advanced/Metastatic Urothelial Carcinoma
Title: Avelumab (MSB0010718C), an anti-PD-L1 antibody, in patients with locally advanced or metastatic urothelial carcinoma: a Phase Ib trial
Lead author: Apolo AB
Abstract #: 2630
Presentation date/time (CET): September 28, 16:45-18:45
Session: Poster Session: Genitourinary Malignancies - Nonprostate Cancer (P#121)
Room/details: Hall C

Tumor Type: Advanced, Unresectable Mesothelioma
Title: Safety and clinical activity of avelumab (MSB0010718C), an anti-PD-L1 antibody, in patients with advanced, unresectable mesothelioma: a Phase Ib trial
Lead author: Hassan R
Abstract #: 3110
Presentation date/time (CET): September 27, 09:15-11:15
Session: Poster Session: Lung Cancer - Metastatic Disease (P#362)
Presentation date/time (CET): September 27, 09:45-10:45
Session: Poster spotlight session: Lung cancer
Room/details: Hall C

Tumor Type: Oesophageal Squamous Cell Carcinoma
Title: Prognostic significance of tumour-infiltrating immune cells and PD-L1 expression in oesophageal squamous cell carcinoma in Chinese patients
Lead author: Jiang Y
Abstract #: 2398
Presentation date/time (CET): September 28, 09:15-11:15
Session: Poster Session: Gastrointestinal Malignancies - Noncolorectal Cancer (P#360)
Room/details: Hall C

Evofosfamide  

Tumor Type: Advanced Pancreatic
Title: Japanese Phase I trial of hypoxia-activated prodrug evofosfamide (TH-302) as monotherapy in patients with solid tumors or in combination with gemcitabine in patients with advanced pancreatic cancer
Lead author: Mitsunaga S
Abstract #: 2312
Presentation date/time (CET): September 28, 09:15-11:15
Session: Poster Session: Gastrointestinal Malignancies - Noncolorectal Cancer (P#274)
Room/details: Hall C

Tepotinib  

Tumor Type: Solid Tumours
Title: Identification of the recommended Phase II dose (RP2D) of the c-Met Inhibitor tepotinib (MSC2156119J) in Japanese patients (pts) with solid tumors: a Phase I trial
Lead author: Yamazaki K
Abstract #: 365
Presentation date/time (CET): September 27, 16:45-18:45
Session: Poster Session: Early Drug Development I (P#176)
Room/details: Hall C

Tumor Type: Advanced Hepatocellular
Title: Data from a Phase Ib/II trial of the oral c-Met inhibitor tepotinib (MSC2156119J) as first-line therapy in Asian patients with advanced hepatocellular carcinoma
Lead author: Qin S
Abstract #: 2353
Presentation date/time (CET): September 28, 09:15-11:15
Session: Poster Session: Gastrointestinal Malignancies - Noncolorectal Cancer (P#315)
Room/details: Hall C

Tumor Type: c-Met-positive EGFR mutant NSCLC
Title: The highly selective c-Met inhibitor tepotinib in combination with gefitinib is active in Asian patients with c-Met-positive EGFR mutant NSCLC
Lead author: Soo RA
Abstract #: 3082
Presentation date/time (CET): September 27, 09:15-11:15
Session: Lung Cancer - Metastatic Disease (P#334)
Room/details: Hall C

Tumor Type: n/a
Title: Open-label, single center, Phase I trial to investigate the mass balance and absolute bioavailability of the oral c-Met inhibitor tepotinib
Lead author: Johne A
Abstract #: 369
Presentation date/time (CET): September 27, 16:45-18:45
Session: Poster Session: Early Drug Development I (P#180)
Room/details: Hall C

Avelumab, evofosfamide, tepotinib and all early-stage products are currently under clinical investigation and have not been approved for use in the U.S., E.U., 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.

The full Erbitux patient information is available online at http://www.ema.europa.eu/ema

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

References  

1.  Heery C, et al. J Clin Oncol 33, 2015 (suppl; abstr 3055).
2.  Kelly K, et al. J Clin Oncol 33, 2015 (suppl; abstr 3044).
3.  Shitara K, et al. J Clin Oncol 33, 2015 (suppl; abstr 3023).
4.  Heery C, et al. J Clin Oncol 33, 2015 (suppl; abstr TPS3101).
5.  Gulley J, et al. J Clin Oncol 33, 2015 (suppl; abstr 8034).
6.  Disis M, et al. J Clin Oncol 33, 2015 (suppl; abstr 5509).
7.  Yamada Y, et al. J Clin Oncol 33, 2015 (suppl; abstr 4047).
8.  Kaufman H, et al. J Clin Oncol 33, 2015 (suppl; abstr TPS9086).
9.  Geng R, et al. J Clin Oncol 33, 2015 (suppl; abstr 4042).
10. Tsang K, et al. J Clin Oncol 33, 2015 (suppl; abstr 3038).

About Erbitux  

Erbitux^® is a 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 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 U.S. 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 Evofosfamide  

Evofosfamide (previously known as TH-302) is an investigational hypoxia-activated prodrug that is thought to be activated under severe tumor hypoxic conditions, a feature of many solid tumors. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood vessel supply. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.

Evofosfamide is currently under evaluation in two Phase III trials: one in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable or metastatic soft tissue sarcoma (the TH-CR-406 trial), and the other in combination with gemcitabine versus gemcitabine and placebo in patients with locally advanced unresectable or metastatic pancreatic cancer (the MAESTRO trial). Both Phase III trials are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. The FDA and the European Commission have granted evofosfamide Orphan Drug designation for the treatment of STS and pancreatic cancer. The FDA has also granted Fast Track designation to evofosfamide for the treatment of pancreatic cancer and soft tissue sarcoma. Evofosfamide is also being investigated in a Phase II trial for the treatment of non-squamous non-small cell lung cancer, and in earlier-stage clinical trials of other solid tumors and hematological malignancies.

Merck signed a global license and co-development agreement for evofosfamide with Threshold Pharmaceuticals, Inc. in February 2012, with an option for Threshold to co-commercialize in the U.S.

About Tepotinib  

Tepotinib (also known as MSC2156119J or EMD1214063) is an investigational small-molecule inhibitor of the c-Met receptor tyrosine kinase that has been shown to cause growth inhibition and regression of tumors with c-Met mutations, c-Met overexpression or hepatocyte growth factor secretion in preclinical models. Tepotinib is currently under evaluation in Phase I/II trials.

About Avelumab  

Avelumab (also known as MSB0010718C) is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody. By inhibiting PD-L1 interactions, avelumab is thought to enable the activation of T-cells and the adaptive immune system. By retaining a native Fc-region, avelumab is thought to engage the innate immune system and induce antibody-dependent cell-mediated cytotoxicity (ADCC). In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

About Merck-Pfizer Alliance  

Immuno-oncology is a top priority for Merck and Pfizer. The global strategic alliance between Merck and Pfizer enables the companies to benefit from each other's strengths and capabilities and further explore the therapeutic potential of avelumab, an investigational anti-PD-L1 antibody initially discovered and developed by Merck. The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer's PD-1 antibody. The alliance will collaborate on up to 20 high priority immuno-oncology clinical development programs, including combination trials, many of which are expected to commence in 2015.

About Merck Serono  

Merck Serono is the biopharmaceutical business 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 healthcare, life science and performance materials. The company has six businesses - Merck Serono, Consumer Health, Allergopharma, Biosimilars, Merck Millipore and Performance Materials - and generated total revenues of € 11.3 billion in 2014. Around 39,000 Merck employees work in 66 countries to improve the quality of life for patients, to foster the success of 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, holds the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company operates as EMD Serono, EMD Millipore and EMD Performance Materials.