Merck Healthcare

Merck to Present Data at ASCO That Illustrate How the Company is Tackling Difficult-to-Treat Cancers

Darmstadt, Germany (ots/PRNewswire) - - NOT INTENDED FOR US AND UK BASED MEDIA -

ASCO Abstract # Avelumab*: 3023, 3044, 3055, TPS9086, TPS3101, 4042, 4047, 5509, 8034; evofosfamide: TPS9089, 8579; tepotinib: 2591; tecemotide[*]: 3036.

- New data on priority candidates from Merck's oncology and immuno-oncology
  pipeline are being presented, including avelumab, evofosfamide and tepotinib
 

Merck will be presenting data at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO), held in Chicago, Illinois, U.S., from May 29 to June 2, 2015. The data embody the company's focus on cancers that are particularly difficult to treat and the ultimate goal to provide treatments that help to prolong patients' lives.

"We are focused on shedding light on difficult-to-treat cancers, such as soft tissue sarcomas and Merkel cell carcinoma, in order to make a meaningful difference for patients," said Luciano Rossetti, Head of Global Research and Development, Merck Serono, the biopharmaceutical business of Merck. "Our data at ASCO 2015 demonstrate our commitment to deliver innovation, through our internal expertise and capabilities, and through strategic collaborations to advance differentiated new therapies for these cancers."

Illumination and Innovation in Difficult-to-Treat Cancers

Through a bold, science-focused and patient-driven approach, Merck aims to discover and develop new therapies in cancers such as ovarian cancer, metastatic Merkel cell carcinoma and advanced hepatocellular carcinoma. Highlights from this year's ASCO include data from the investigational fully human anti-PD-L1 monoclonal antibody avelumab (also known as MSB0010718C), the investigational c-Met inhibitor tepotinib (also known as MSC2156119J), and evofosfamide (previously known as TH-302), an investigational hypoxia-activated prodrug.

Abstracts are currently available on the ASCO website [http://abstracts.asco.org].

Collaborating to Tackle Cancer's Most Challenging Issues

Merck and Pfizer are collaborating on up to 20 high priority immuno-oncology clinical development programs focused on the therapeutic potential of avelumab which was initially discovered and developed by Merck. This is the first time data will be presented jointly on behalf of the alliance, including an oral presentation on ovarian cancer and posters on gastric cancer, non-small cell lung cancer and several other studies in a range of patient populations.

In addition, posters from two Phase II studies will be presented for evofosfamide in multiple myeloma and melanoma. Evofosfamide is being co-developed with Threshold Pharmaceuticals, Inc. and is currently in Phase III studies for the treatment of soft tissue sarcoma and for pancreatic cancer, as well as in a Phase II trial for the treatment of non-squamous non-small cell lung cancer.

Precision Medicine to Improve Patient Care

Merck continues to place a strong emphasis on biomarker-driven research with the goal of delivering personalized treatments and improving patient outcomes. The company will be presenting data on tepotinib, from a study evaluating the activity of tepotinib in patients with solid tumors that overexpress c-Met. In addition, new analyses from several independent studies will be presented that will offer further insight into the value of Erbitux(R) (cetuximab) in the treatment of 1st line RAS wild-type metastatic colorectal cancer.

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

[*] In September 2014, Merck discontinued all company-sponsored clinical trials with tecemotide in non-small cell lung cancer worldwide.

Notes to Editors

Accepted abstracts submitted by Merck related to our oncology and immuno-oncology pipeline are listed below. In addition, a number of investigator-sponsored studies have been accepted, including several related to Erbitux and one to avelumab (not listed).

Avelumab
Title: Phase I, open-label, multi-ascending dose trial of avelumab (MSB0010718C), an
 anti-PD-L1 monoclonal antibody, in Japanese patients with advanced solid tumors
Lead Author: K Shitara
Abstract #: 3023
Presentation date/time (CDT): May 30, 08:00-11:30
Session: Poster Session: Developmental Therapeutics-Immunotherapy
Room/Details: S Hall A (Poster Board: 349)

Title: Avelumab (MSB0010718C), an anti-PD-L1 antibody, in patients with metastatic or
 locally advanced solid tumors: assessment of safety and tolerability in a Phase I,
 open-label expansion study
Lead Author: K Kelly
Abstract #: 3044
Presentation date/time (CDT): May 30, 08:00-11:30
Session: Poster Session: Developmental Therapeutics-Immunotherapy
Room/Details:  S Hall A (Poster Board: 370)

Title: Pharmacokinetic profile and receptor occupancy of avelumab (MSB0010718C), an
 anti-PD-L1 monoclonal antibody, in a Phase I, open-label, dose escalation trial in
 patients with advanced solid tumors
Lead Author: C Heery
Abstract #: 3055
Presentation date/time (CDT): May 30, 08:00-11:30
Session: Poster Session: Developmental Therapeutics-Immunotherapy
Room/Details: S Hall A (Poster Board: 381)

Title: A Phase II, open-label, multicenter trial to investigate the clinical activity
 and safety of avelumab (MSB0010718C) in patients with metastatic Merkel cell carcinoma
Lead Author: H Kaufman
Abstract #: TPS9086
Presentation date/time (CDT): May 30, 08:00-11:30
Session: Poster Session: Melanoma/Skin Cancers
Room/Details: S Hall A (Poster Board: 417a)

Title: Phase I expansion cohort trial to investigate the safety and clinical activity
 of avelumab (MSB0010718C) in patients with metastatic or locally advanced solid tumors
Lead Author: C Heery
Abstract #: TPS3101
Presentation date/time (CDT): May 30, 08:00-11:30
Session: Poster Session: Developmental Therapeutics-Immunotherapy
Room/Details: S Hall A (Poster Board: 420a)

Title: Prognostic significance of tumor infiltrating immune cells and PD-L1 expression
 in gastric carcinoma in Chinese patients
Lead Author: R Geng
Abstract #: 4042
Presentation date/time (CDT): June 1, 08:00-11:30
Session: Poster Session: Gastrointestinal (Noncolorectal) Cancer
Room/Details: S Hall A (Poster Board: 151)

Title: A Phase I dose expansion trial of avelumab (MSB0010718C), an anti-PD-L1
 antibody, in Japanese patients with advanced gastric cancer
Lead Author: Y Yamada
Abstract #: 4047
Presentation date/time (CDT): June 1, 08:00-11:30
Session: Poster Session: Gastrointestinal (Noncolorectal) Cancer
Room/Details: S Hall A (Poster Board: 156)

Title: Avelumab (MSB0010718C), an anti-PD-L1 antibody, in patients with previously
 treated, recurrent or refractory ovarian cancer: a Phase Ib, open-label expansion
 trial
Lead Author: M Disis
Abstract #:5509
Presentation date/time (CDT): June 1, 15:00-15:12
Session: Oral Presentation: Clinical Science Symposium
Room/Details: E354b

Title: Avelumab (MSB0010718C), an anti-PD-L1 antibody, in advanced NSCLC patients: a
 Phase Ib, open-label ex
pansion trial in patients progressing after platinum-based chemotherapy
Lead Author: J Gulley
Abstract #: 8034
Presentation date/time (CDT): June 1, 08:00-11:30
Session: Poster Session: Lung Cancer- Non-Small Cell Metastatic
Room/Details: S Hall A (Poster Board: 356)

Evofosfamide

Title: A Phase II biomarker-enriched study of evofosfamide (EVO, TH-302) in patients
 with advanced melanoma
Lead Author: E McWhirter
Abstract #: TPS9089
Presentation date/time (CDT): June 1, 13:15-16:45
Session: Poster Session: Melanoma/Skin Cancers
Room/Details: S Hall A  (Poster Board: 327a)

Title: Preliminary safety and efficacy of evofosfamide (TH-302), an investigational
 hypoxia-activated prodrug combined with bortezomib and dexamethasone in patients with
 relapsed/refractory multiple myeloma (RRMM)
Lead Author: JP Laubach
Abstract #: 8579
Presentation date/time (CDT): May 31, 08:00-11:30
Session: Poster Session: Lymphoma and Plasma Cell Disorders
Room/Details: S Hall A (Poster Board: 397)

Tepotinib

Title: Efficacy, safety, biomarkers and Phase II dose modeling in a Phase I trial of
 the oral selective c-Met inhibitor tepotinib (MSC2156119J)
Lead Author: GS Falchook
Abstract #: 2591
Presentation date/time (CDT): May 30, 08:00-11:30
Session: Poster Session: Developmental Therapeutics-Clinical Pharmacology and
 Experimental Therapeutics
Room/Details: S Hall A (Poster Board: 307)

Other Pipeline

Title: Phase I/II study of tecemotide cancer immunotherapy for Japanese patients with
 unresectable Stage III non-small cell lung cancer (NSCLC)
Lead Author: H Nokihara
Abstract #: 3036
Presentation date/time (CDT): May 30, 08:00-11:30
Session: Poster Session: Developmental Therapeutics-Immunotherapy
Room/Details: S Hall A (Poster Board: 362)
 

Avelumab, evofosfamide, tecemotide, 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.

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 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. 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) is an investigational small-molecule inhibitor of the c-Met receptor tyrosine kinase that has been shown to cause growth inhibition and regression of hepatocyte growth factor-dependent and -independent tumors in preclinical models. 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 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.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

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 EUR 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.

Contact:

Contact: Cornelia Bartels, Phone +49-6151-72-3890

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