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Merck To Present Data at ASCO that Illustrate How the Company is Tackling Difficult-to-Treat Cancers – Courtesy(Pharmaceutical Online)
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Merck KGaA, Darmstadt, Germany, 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 sarcoma and Merkel cell carcinoma in order to make a meaningful difference for patients,” said Luciano Rossetti, Head of Global Research and Development at the biopharmaceutical business of Merck KGaA, Darmstadt, Germany. “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 KGaA, Darmstadt, Germany, 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.

Collaborating to Tackle Cancer’s Most Challenging Issues

Merck KGaA, Darmstadt, Germany 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 KGaA, Darmstadt, Germany. 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 KGaA, Darmstadt, Germany 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.

*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 KGaA, Darmstadt, Germany related to our oncology and immuno-oncology pipeline are listed below. In addition, a number of investigator sponsored studies have been accepted, including one related to avelumab.

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

(Poster Board: 349)

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
K Kelly 3044 May 30,

08:00–11:30

Poster session:

Developmental Therapeutics—Immunotherapy

S Hall A
(Poster Board: 370)
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
C Heery 3055 May 30,
08:00–11:30
Poster Session:

Developmental Therapeutics—Immunotherapy

S Hall A

(Poster Board: 381)

A Phase II, open-label, multicenter trial to investigate the clinical activity and safety of avelumab (MSB0010718C) in patients with metastatic Merkel cell carcinoma H Kaufman TPS9086 May 30,
08:00–11:30
Poster Session:
Melanoma/Skin Cancers
S Hall A

(Poster Board: 417a)

Phase I expansion cohort trial to investigate the safety and clinical activity of avelumab (MSB0010718C) in patients with metastatic or locally advanced solid tumors C Heery TPS3101 May 30,

08:00–11:30

Poster Session:

Developmental Therapeutics—Immunotherapy

S Hall A

(Poster Board: 420a)

Prognostic significance of tumor infiltrating immune cells and PD-L1 expression in gastric carcinoma in Chinese patients R Geng 4042 June 1,
08:00–11:30
Poster Session:

Gastrointestinal (Noncolorectal) Cancer

S Hall A
(Poster Board: 151)
A Phase I dose expansion trial of avelumab (MSB0010718C), an
anti-PD-L1 antibody, in Japanese patients with advanced gastric cancer
Y Yamada 4047 June 1,
08:00–11:30
Poster Session:

Gastrointestinal (Noncolorectal) Cancer

S Hall A

(Poster Board: 156)

Avelumab (MSB0010718C), an
anti-PD-L1 antibody, in patients with previously treated, recurrent or refractory ovarian cancer: a Phase Ib, open-label expansion trial
M Disis 5509 June 1,

15:00–15:12

Oral presentation:
Clinical Science Symposium
E354b
Avelumab (MSB0010718C), an
anti-PD-L1 antibody, in advanced NSCLC patients: a Phase Ib, open-label expansion trial in patients progressing after platinum-based chemotherapy
J Gulley  8034 June 1,
08:00–11:30

Poster Session:

Lung Cancer—Non-Small Cell Metastatic

S Hall A

(Poster Board: 356)

Title Lead author Abstract # Presentation date/time (CDT) Session Room/
Details
Evofosfamide
A Phase II biomarker-enriched study of evofosfamide (EVO,
TH-302) in patients with advanced melanoma
E McWhirter TPS9089 June 1,

13:15–16:45

Poster Session: Melanoma/Skin Cancers S Hall A

(Poster Board: 327a)

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) JP Laubach 8579 May 31,
08:00–11:30
Poster Session: Lymphoma and Plasma Cell Disorders S Hall A

(Poster Board: 397)

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

(Poster Board: 307)

Title Lead author Abstract # Presentation date/time (CDT) Session Room/
Details
Other Pipeline
Phase I/II study of tecemotide cancer immunotherapy for Japanese patients with unresectable Stage III
non-small cell lung cancer (NSCLC)
H Nokihara 3036 May 30,

08:00–11:30

Poster Session: Developmental Therapeutics—Immunotherapy 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.

In the United States and Canada, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, operates as EMD Serono.

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 KGaA, Darmstadt, Germany 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 investigationalsmall-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 KGaA, Darmstadt, Germany and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

Alliance between Merck KGaA, Darmstadt, Germany and Pfizer Inc., New York, U.S.

Immuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany and Pfizer Inc. The global strategic alliance between Merck KGaA, Darmstadt, Germany and Pfizer Inc, New York, U.S., 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 KGaA, Darmstadt, Germany.  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 EMD Serono, Inc.

EMD Serono is the U.S. and Canadian subsidiary of Merck KGaA, Darmstadt, Germany’s biopharmaceutical business. A leading U.S. biopharma company, EMD Serono is focused exclusively on specialty care. For more than 40 years, EMD Serono has integrated cutting-edge science, innovative products and devices, and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology as well as a robust pipeline of potential therapies in neurology, oncology, immunology and immuno-oncology. Today, EMD Serono has more than 1,100 employees around the country with commercial, clinical and research operations based in the company’s home state of Massachusetts.

For more information, please visit www.emdserono.com

Merck Group

Merck KGaA of Darmstadt, Germany, is a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials. The company has six businesses – Biopharmaceuticals, Consumer Health, Allergopharma, Biosimilars, Life Science and Performance Materials – and generated sales of € 11.3 billion in 2014. Around 39,000 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 KGaA, Darmstadt, Germany, 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 KGaA, 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.



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