Merck KGaA

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

Darmstadt, Germany (ots/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.

(Logo: http://photos.prnewswire.com/prnh/20160518/369530LOGO )

"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® (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 ± 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) ± 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® 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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