Bringing Innovation to Patients: Merck Presents New Advances at ASCO 2016

DARMSTADT, Germany, May 18, 2016 /PRNewswire/ --





Not intended for UK- or US-based media     ASCO Abstract #

Avelumab: 4009, TPS4134, TPS4135, 9036, TPS9105, 3055, TPS3106, 8503, 4514, 4516, 5533, TPS5600, TPS4580, 9508; tepotinib: 4072


- Abstracts featuring Merck compounds span a broad range of cancers, with an
emphasis on those which are difficult-to-treat and represent significantunmet patient
need      
- Avelumab data in seven different cancers from rapidly accelerating JAVELIN clinical
program to be presented    



Merck, a leading science and technology company, announced that this year's Annual Meeting of the American Society of Clinical Oncology (ASCO; June 3-7, 2016, Chicago, IL, U.S.) will feature research on Merck compounds across a broad range of cancers. These reports, which focus on cancers with significant unmet patient need, will inform and advance scientific knowledge within the oncology community. This includes data on avelumab*, Merck's high priority, late-stage investigational immuno-therapy, that is being developed in collaboration with Pfizer.

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"We have a clear and focused commitment to accelerate oncology innovation and transform the way cancer is treated, both by leveraging our internal expertise and capabilities, and through our collaborations," said Luciano Rossetti, Executive Vice President, Head of Global Research & Development at the biopharma business of Merck. "Avelumab is an example of this strategy coming to life, as it was originally discovered by Merck and is being co-developed with Pfizer. More broadly, we will be presenting data across multiple tumor types at ASCO as we continue to advance our oncology and immuno-oncology pipeline."

Collaborating to bring innovation to cancer patients    

Merck and Pfizer are presenting avelumab data at this year's congress that reflect the significant progress this alliance is making. This includes results from the pivotal, Phase II metastatic Merkel cell carcinoma trial which, taken together with data from other challenging tumors being evaluated in the JAVELIN clinical development program, supports efficacy and a favorable safety profile for avelumab. Avelumab, an investigational, fully human, anti-programmed death-ligand 1 (PD-L1) monoclonal antibody, has a dual mechanism of action that is believed to enable the immune system to find and attack cancer cells. Avelumab's clinical program, one of the largest immuno-oncology development programs, now includes approximately 2,200 patients across more than 15 tumor types. Together, the two companies have initiated 30 ongoing monotherapy or combination therapy programs with avelumab, including nine pivotal studies.

Innovation: treatment and beyond    

Erbitux(R) (cetuximab) and precision medicine remain a strategic priority for Merck. As a cornerstone of treatment in RAS wild-type mCRC and SCCHN, Merck is committed to exploring Erbitux as an 'anchor' treatment in combination with immuno-therapies in these indications. Erbitux also continues to captivate the interest of leading researchers and the medical community with more than 30 abstracts at ASCO, the majority from investigator-led studies.

Merck aims to improve patients' experiences along their treatment journey by helping patients and physicians to make faster treatment decisions. Merck is the first pharmaceutical company to collaborate with multiple diagnostic companies to co-develop and commercialize innovative liquid biopsy RAS biomarker tests to determine which patients with mCRC would benefit from treatment with Erbitux. At ASCO, Merck's partner Sysmex Inostics will be presenting new data demonstrating the value of the co-developed and commercialized liquid biopsy test, which received CE mark approval earlier this year.

Truly innovative pipeline    

Following Merck's strategic reassessment of its portfolio, there is significant potential with later-stage priority programs and Merck's truly innovative early pipeline. Six out of seven of the current pipeline products in Phases I-III were discovered in Merck's labs.

Data will be presented on another of these Merck-discovered compounds, tepotinib**, an investigational, highly selective, small molecule inhibitor of the c-Met receptor tyrosine kinase. The ASCO presentation will report on tepotinib's clinical activity and tolerability in Asian patients with advanced hepatocellular carcinoma, a cancer in which there is a considerable need for new treatment options.

Through Merck's Translational Innovation Platforms in oncology and immuno-oncology, the company is developing differentiated therapeutic drugs targeting distinct cancer hallmarks and multiple immune-system-mediated mechanisms. These include, among others, DNA repair, antibody drug conjugates, oncogenes, tumor antigens, T-cell therapies, and targeted cytokines and chemokines.

*Avelumab is the proposed nonproprietary name for the anti-PD-L1 mAb (also known as MSB0010718C).

**Tepotinib is the proposed nonproprietary name for the c-Met kinase inhibitor (also known as MSC2156119J).

Avelumab and tepotinib are under clinical investigation and have not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication by any health authority worldwide.

Notes to Editors    

Accepted Merck-supported abstracts are listed below. In addition, a number of investigator-sponsored studies have been accepted, including several related to Erbitux and avelumab (not listed).


 
Avelumab    

 
Title: Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced gastric or
gastroesophageal junction cancer from the JAVELIN Solid Tumor Phase Ib trial: analysis
of safety, clinical activity 
Lead Author: C Chung 
Abstract #: 4009 
Presentation Date/Time (CDT): June 4 08:00-11:30 
Session: Poster Session: Gastrointestinal (Noncolorectal) Cancer 
Room/Details: Hall A (Poster Board: 1)

 
Title: Maintenance therapy with avelumab (MSB0010718C; anti-PD-L1) vs continuation of
first-line chemotherapy in patients with unresectable, locally advanced or metastatic
gastric cancer: the Phase III JAVELIN Gastric 100 trial 
Lead Author: M Moehler 
Abstract #: TPS4134 
Presentation Date/Time (CDT): June 4 08:00-11:30 
Session: Poster Session: Gastrointestinal (Noncolorectal) Cancer 
Room/Details: Hall A (Poster Board: 124b)

 
Title: Avelumab (MSB0010718C; anti-PD-L1) + best supportive care (BSC) vs BSC plus or
minus chemotherapy as third-line treatment for patients with unresectable, recurrent,
or metastatic gastric cancer: the Phase III JAVELIN Gastric 300 trial 
Lead Author: Y-J Bang 
Abstract #: TPS4135 
Presentation Date/Time (CDT): June 4 08:00-11:30 
Session: Poster Session: Gastrointestinal (Noncolorectal) Cancer 
Room/Details: Hall A (Poster Board: 125a)

 
Title: Avelumab (MSB0010718C; anti-PD-L1) as a first-line treatment for patients with
advanced NSCLC from the JAVELIN Solid Tumor Phase Ib trial: safety, clinical activity,
and PD-L1 expression 
Lead Author: C Verschraegen 
Abstract #: 9036 
Presentation Date/Time (CDT): June 4 08:00-11:30 
Session: Poster Session: Lung Cancer-Non-Small Cell Metastatic 
Room/Details: Hall A (Poster Board: 359)

 
Title: Avelumab (MSB0010718C; anti-PD-L1) vs platinum-based doublet as first-line
treatment for metastatic or recurrent PD-L1-positive non-smallcell lung cancer: the
Phase III JAVELIN Lung 100 trial 
Lead Author: M Reck 
Abstract #: TPS9105 
Presentation Date/Time (CDT): June 4 08:00-11:30 
Session: Poster Session: Lung Cancer-Non-Small Cell Metastatic 
Room/Details: Hall A (Poster Board: 425a)

 
Title: Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced cancer: safety data
from 1300 patients enrolled in the Phase Ib JAVELIN Solid Tumor trial 
Lead Author: K Kelly 
Abstract #: 3055 
Presentation Date/Time (CDT): June 5 08:00-11:30 
Session: Poster Session: Developmental Therapeutics-Immunotherapy 
Room/Details: Hall A (Poster Board: 377)

 
Title: Avelumab (MSB0010718C; anti-PD-L1) in combination with other cancer
immunotherapies in patients with advanced malignancies: the Phase Ib/II JAVELIN Medley
study 
Lead Author: A Ribas 
Abstract #: TPS3106 
Presentation Date/Time (CDT): June 5 08:00-11:30 
Session: Poster Session: Developmental Therapeutics-Immunotherapy 
Room/Details: Hall A (Poster Board: 422b)

 
Title: Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced unresectable
mesothelioma from the JAVELIN Solid Tumor Phase Ib trial: safety, clinical activity,
and PD-L1 expression 
Lead Author: R Hassan 
Abstract #: 8503 
Presentation Date/Time (CDT): June 5 08:00-11:05 
Session: Oral Abstract Session: Lung Cancer-Non-Small Cell Local-Regional/Small
Cell/Other Thoracic Cancers 
Room/Details: Arie Crown Theater

 
Title: Avelumab (MSB0010718C; anti-PD-L1) in patients with metastatic urothelial
carcinoma from the JAVELIN Solid Tumor Phase Ib trial: analysis of safety, clinical
activity, and PD-L1 expression 
Lead Author: A Apolo 
Abstract #: 4514 
Presentation Date/Time (CDT): June 6 13:00-16:30 
Session: Poster Session: Genitourinary (Nonprostate) Cancer 
Room/Details: Hall A (Poster Board: A137)

 
Title: Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced adrenocortical
carcinoma from the JAVELIN Solid Tumor Phase Ib trial: safety and clinical activity 
Lead Author: C Le Tourneau 
Abstract #: 4516 
Presentation Date/Time (CDT): June 6 13:00-16:30 
Session: Poster Session: Genitourinary (Nonprostate) Cancer 
Room/Details: Hall A (Poster Board: 138)

 
Title: Avelumab (MSB0010718C; anti-PD-L1) in patients with recurrent/refractory ovarian
cancer from the JAVELIN Solid Tumor Phase Ib trial: safety and clinical activity 
Lead Author: M Disis 
Abstract #: 5533 
Presentation Date/Time (CDT): June 6 13:00-16:30 
Session: Poster Session: Gynecologic Cancer 
Room/Details: Hall A (Poster Board: 356)

 
Title: Avelumab (MSB0010718C; anti-PD-L1) plus or minus pegylated liposomal doxorubicin
vs pegylated liposomal doxorubicin alone in patients with
platinum-resistant/refractory ovarian cancer: the Phase III JAVELIN Ovarian 200 trial 
Lead Author: E Pujade-Lauraine 
Abstract #: TPS5600 
Presentation Date/Time (CDT): June 6 13:00-16:30 
Session: Poster Session: Gynecologic Cancer 
Room/Details: Hall A (Poster Board: 421b)

 
Title: Avelumab (MSB0010718C; anti-PD-L1) in combination with axitinib as first-line
treatment for patients with advanced renal cell carcinoma 
Lead Author: J Larkin 
Abstract #: TPS4580 
Presentation Date/Time (CDT): June 6 13:00-16:30 
Session: Poster Session: Genitourinary (Nonprostate) Cancer 
Room/Details: Hall A (Poster Board: 199a)

 
Title: Avelumab (MSB0010718C; anti-PD-L1) in patients with metastatic Merkel cell
carcinoma previously treated with chemotherapy: results of the Phase II JAVELIN Merkel
200 trial 
Lead Author: H Kaufman 
Abstract #: 9508 
Presentation Date/Time (CDT): June 6 13:15-16:15 
Session: Oral Abstract Session: Melanoma/Skin Cancers 
Room/Details: Arie Crown Theater

 
Tepotinib    

 
Title: Tolerability and activity of tepotinib in Asian patients with advanced
hepatocellular carcinoma (HCC) 
Lead Author: S Qin 
Abstract #: 4072 
Presentation Date/Time (CDT): June 4 08:00-11:30 
Session: Poster Session: Gastrointestinal (Noncolorectal) Cancer 
Room/Details: Hall A (Poster Board: 64) 



 

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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 potentially 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 Erbitux    

Erbitux(R) 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 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 Tepotinib    

Tepotinib (also known as MSC2156119J) is an investigational small-molecule inhibitor of the c-Met receptor tyrosine kinase capable of inhibiting both hepatocyte growth factor-dependent and -independent c-Met activation in low nanomolar concentrations. Alterations of the c-Met signaling pathway are found in various cancer types and correlate with aggressive tumor behavior and poor clinical prognosis. Tepotinib is currently under evaluation in Phase I/II trials.

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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