Merck Decides Not to Pursue Evofosfamide Further in Soft Tissue Sarcoma and Pancreatic Cancer

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DARMSTADT, Germany, Dec. 7 / PRNewswire=KYODO JBN/ --

    Not intended for UK-based media

    - Despite signs of activity in locally advanced and metastatic pancreatic

cancer, two Phase III studies did not meet pre-specified primary endpoints

    - Merck will focus efforts on more promising candidates in pipeline

    Merck, a leading science and technology company, today announced that it is

not planning to file for approval of evofosfamide in advanced soft tissue

sarcoma and advanced pancreatic adenocarcinoma. The decision was made in light

of the results from two Phase III studies of evofosfamide in combination with

chemotherapy in these two types of cancer, as reported by Threshold

Pharmaceuticals Inc. today. Merck will now be redeploying its resources into

high-profile future products, such as avelumab* and all other priority programs

in oncology, immuno-oncology and immunology.

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    "Despite seeing signs of activity in pancreatic cancer, pre-specified

primary endpoints were not met in both studies and therefore the data do not

support filing in these indications," said Luciano Rossetti, Head of Global

Research and Development of Merck's biopharma business. "We decided today not

to pursue investigation of evofosfamide in soft tissue sarcoma and pancreatic

cancer, and we will be making a quick decision on the future of the ongoing

evofosfamide clinical program."

    Details of the two Phase III studies will be shared with the scientific

community once the data have been further analyzed.

    "Today's results are disappointing for patients. Yet we are confident in

our pipeline and will reallocate evofosfamide resources to accelerate other key

programs in oncology and immuno-oncology," said Rossetti.

    Merck's pharmaceutical pipeline is focusing on oncology, immuno-oncology

and immunology. In immuno-oncology, Merck, together with Pfizer, is researching

avelumab, an investigational anti-PD-L1 antibody, in more than 15 tumor types.

    *Avelumab is the proposed International Nonproprietary Name for the

anti-PD-L1 monoclonal antibody (MSB0010718C). Avelumab is under clinical

investigation and has 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.

    About Evofosfamide

    Evofosfamide (previously known as TH-302) is an investigational

hypoxia-activated prodrug of a bis-alkylating agent that is preferentially

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.

    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.

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    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 2014, Merck generated sales of EUR 11.3 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.

SOURCE: Merck