Bringing Innovation to Patients: Merck Presents New Advances at ASCO 2016 (y 2)

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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