Thursday, August 31, 2017

Merck KGaA, Darmstadt, Germany: Driving Innovation in Cancer Care at ESMO 2017 With New Data in Hard-to-Treat Cancers

         -Not intended for UK-based media

          -Data to showcase Merck KGaA, Darmstadt, Germany's strong and diverse pipeline ranging from immuno-oncology to DNA damage response
          - Avelumab data validate potential in hard-to-treat cancers and highlight progress of the JAVELIN clinical development program
          - First data in mTNBC for ATR inhibitor (M6620) from Merck KGaA, Darmstadt, Germany's comprehensive portfolio in DNA damage response



          Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced it will present data for a number of tumor types across its rapidly evolving pipeline. A total of 23 abstracts, representing five therapeutic agents, will highlight the company's expanding scientific expertise at this year's European Society for Medical Oncology congress (ESMO 2017; September 8-12, Madrid, Spain).

          Data to be presented include continued reinforcement of the role of established brand Erbitux(R) (cetuximab) as a standard of care therapy, with quality of life (QoL) data in colorectal cancer (CRC) and real-world data in both CRC and squamous cell carcinoma of the head and neck (SCCHN); updated efficacy and safety data for avelumab in metastatic Merkel cell carcinoma (mMCC) and urothelial carcinoma (UC) among other cancers; and new data and updates from Merck KGaA, Darmstadt, Germany's rapidly evolving pipeline, including first data from potential first-in-class ataxia telangiectasia and Rad3-related protein (ATR) inhibitor M6620* (also known as VX-970).

          "The Merck KGaA, Darmstadt, Germany Oncology Franchise has had a momentous year, particularly with the positive regulatory milestones achieved for avelumab. The story continues to evolve at ESMO 2017 from our legacy with Erbitux to our diverse and robust pipeline which has potential novel molecules that could become new standards of care," said Luciano Rossetti, Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany. "The data reinforce Merck KGaA, Darmstadt, Germany's commitment to pursuing approaches that will bring important benefits to patients and transform the way cancer is treated."

          Merck KGaA, Darmstadt, Germany's innovative approach and strategic collaborations in oncology are exemplified through the ongoing partnership with Pfizer, and the significant progress of avelumab. Granted two accelerated approvals** by the U.S. Food and Drug Administration (FDA) this year, more recently the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of avelumab as monotherapy for the treatment of adult patients with mMCC. ESMO 2017 includes new data for avelumab in the treatment of mMCC, a rare and aggressive skin cancer, and 12-month follow-up data in pre-treated patients with locally advanced or metastatic UC. The progress of the broader JAVELIN clinical development program will also be highlighted, with updated data in hard-to-treat tumors such as metastatic adrenocortical carcinoma (mACC).

          The addition of the recently acquired Vertex DNA damage response (DDR) portfolio to its own in-house DDR platform has positioned Merck KGaA, Darmstadt, Germany as one of the key players in the DDR field. The company's broad DDR portfolio includes inhibitors for enzymes of major DDR pathways, such as ATR, DNA-PK and ATM. At ESMO 2017, first data will be presented for ATR inhibitor M6620 in metastatic triple-negative breast cancer (mTNBC). M6620 is currently being investigated in several ongoing Phase I trials across a variety of tumor types.

          Other pipeline updates will include data on the potential first-in-class dual p70S6K/Atk inhibitor M2698*; and tepotinib***, a highly selective c-Met kinase inhibitor, in patients with advanced hepatocellular carcinoma (HCC).

          Product related information contained herein is subject to local product approval and can therefore vary from country to country. For information relevant to your country, please check in with local regulatory authorities.

          *M6620, M2698 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.

          ***Tepotinib is the proposed International Non-proprietary Name (INN) for the c-Met kinase inhibitor (also known as MSC2156119J).



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