Tuesday, October 4, 2016

Merck to Present New Research Focused on Hard-to-Treat Cancers at ESMO 2016




          - Merck to feature new research from marketed and pipeline compounds
          - Preliminary results from combination study with avelumab in renal cell carcinoma, and updates on Phase II tepotinib program in non-small cell lung cancer, to be presented
          - Merck to announce 2016 Grant for Oncology Innovation winners coinciding with ESMO

          Merck, a leading science and technology company, today announced that new research from their marketed and pipeline compounds will be presented at this year's European Society for Medical Oncology (ESMO; October 7-11, 2016, Copenhagen, Denmark) annual meeting. Presentations will focus on hard-to-treat cancers, and include: study results for Erbitux(R) (cetuximab) in metastatic colorectal cancer (mCRC) and squamous cell carcinoma of the head and neck (SCCHN); preliminary study results in bladder cancer and renal cell carcinoma (RCC) for avelumab, which is being developed in collaboration with Pfizer; and updates on the Phase II program for tepotinib* in non-small cell lung cancer (NSCLC).

          "The data being presented at ESMO reflect our commitment to making a meaningful difference in patients' lives, in particular those who are affected by hard-to-treat cancers," said Luciano Rossetti, Executive Vice President, Head of Global Research & Development at the biopharma business of Merck. "We continue to focus on researching the full potential of Erbitux, as well as our ongoing pipeline development programs for avelumab and other early-stage oncology and immuno-oncology compounds."

          At ESMO, avelumab will be featured in four posters that add to the growing body of evidence of the potential of this investigational compound. These will include data updates in bladder cancer that confirm avelumab's potential in this hard-to-treat cancer; and preliminary results from a combination study with axitinib in RCC that support the rationale to evaluate the combination in a Phase III pivotal study. Tepotinib, a highly selective c-Met kinase inhibitor, will also be highlighted in three posters, with updates on the ongoing study program in c-Met-positive metastatic NSCLC.

          Several studies, which will be presented at ESMO, once again reaffirm Erbitux as a standard-of-care therapy for mCRC patients with RAS wild-type tumors and patients with SCCHN.

          Merck believes that to truly deliver the promise of innovation for patients, it is vital to support and encourage research from other endeavors. This is demonstrated through Merck's Grant for Oncology Innovation (GOI) initiative, which awards researchers for their pioneering independent work in pushing the boundaries of creativity and science in order to deliver transformative innovation. The award ceremony will once again coincide with ESMO and takes place on Sunday, October 9, 2016.

          *Tepotinib is the proposed nonproprietary name for the c-Met kinase inhibitor (also known as MSC2156119J).

          Avelumab 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.

          Notes to Editors

          Accepted Merck-supported abstracts are listed below. In addition, a number of investigator-sponsored studies have been accepted, including several related to Erbitux (not listed).

          Erbitux

          Title: Impact of tumor epidermal growth factor receptor (EGFR) status on the outcomes of first-line FOLFOX-4 plus or minus cetuximab in patients (pts) with RAS-wild-type (wt) metastatic colorectal cancer (mCRC) in the randomized phase 3 TAILOR trial
          Lead Author: S Qin
          Abstract #: 527P
          Presentation date/time (CDT): October 8, 13:00-14:00
          Session: Poster Display Session
          Room/Details: Hall E

          Title: Impact of surgical resection of liver metastases on outcome of patients with metastatic colorectal carcinoma (mCRC) treated with a cetuximab-based first-line therapy - Analysis of the KRAS-wildtype exon 2 (KRAS-wt) subgroup of the German non-interventional study ERBITAG
          Lead Author: U Neumann
          Abstract #: 491P
          Presentation date/time (CDT): October 8, 13:00-14:00
          Session: Poster Display Session
          Room/Details: Hall E

          Title: Observational study of the dose intensity relative to cetuximab in the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck: data on the maintenance and bi-weekly use (DIRECT study)
          Lead Author: J Guigay
          Abstract #: 967P
          Presentation date/time (CDT): October 9, 13:00-14:00
          Session: Poster Display Session
          Room/Details: Hall E

          Title: Cetuximab in combination with platinum-based chemotherapy or radiotherapy in recurrent and/or metastatic SCCHN in a non-selected patient cohort (interim analysis of the phase IV SOCCER trial)
          Lead Author: M Hecht
          Abstract #: 994P
          Presentation date/time (CDT): October 9, 13:00-14:00
          Session: Poster Display Session
          Room/Details: Hall E

          Avelumab

          Title: Avelumab (MSB0010718C; anti-PD-L1) in patients with metastatic urothelial carcinoma progressed after platinum-based therapy or platinum ineligible
          Lead Author: M Patel
          Abstract #: 777PD
          Presentation date/time (CDT): October 9, 16:30-17:30
          Session: Poster Discussion Session Genitourinary tumors, non-prostate
          Room/Details: Athens

          Title: Phase 1b dose-finding study of avelumab (anti-PD-L1) + axitinib in treatment-naive patients with advanced renal cell carcinoma
          Lead Author: J Larkin
          Abstract #: 775PD
          Presentation date/time (CDT): October 9, 16:30-17:30
          Session: Poster Discussion Session Genitourinary tumors, non-prostate
          Room/Details: Athens

          Title: Evaluation of real world treatment outcomes in patients with metastatic Merkel cell carcinoma (MCC) following second line chemotherapy
          Lead Author: J Becker
          Abstract #: 1154P
          Presentation date/time (CDT): October 9, 13:00-14:00
          Session: Poster Display Session
          Room/Details: Hall E

          Title: A multicenter, international, randomized, open-label phase 3 trial of avelumab + best supportive care (BSC) vs BSC alone as maintenance therapy after first-line platinum-based chemotherapy in patients with advanced urothelial cancer (JAVELIN Bladder 100)
          Lead Author: T Powles
          Abstract #: 842TiP
          Presentation date/time (CDT): October 9, 13:00-14:00
          Session: Poster Display Session
          Room/Details: Hall E

          Title: Phase 3 study of avelumab in combination with axitinib versus sunitinib as first-line treatment for patients with advanced renal cell carcinoma (aRCC)
          Lead Author: R Motzer
          Abstract #: 844TiP
          Presentation date/time (CDT): October 9, 13:00-14:00
          Session: Poster Display Session
          Room/Details: Hall E

          Tepotinib

          Title: Tepotinib plus gefitinib in patients with c-Met-positive/EGFR-mutant NSCLC: recommended phase II dose (RP2D), tolerability, and efficacy
          Lead Author: Y-L Wu
          Abstract #: 1257P
          Presentation date/time (CDT): October 8, 13:00-14:00
          Session: Poster Display Session
          Room/Details: Hall E

          Title: Design of a phase II trial comparing tepotinib + gefitinib with cisplatin + pemetrexed in EGFR inhibitor-resistant, c-Met+ NSCLC
          Lead Author: Y-L Wu
          Abstract #: 1287TiP
          Presentation date/time (CDT): October 8, 13:00-14:00
          Session: Poster Display Session
          Room/Details: Hall E

          Title: A phase II trial investigating the highly selective c-Met inhibitor tepotinib in stage IIIB/IV lung adenocarcinoma with MET exon 14 alterations after failure of at least one prior therapy
          Lead Author: P Paik
          Abstract #: 1292TiP
          Presentation date/time (CDT): October 8, 13:00-14:00
          Session: Poster Display Session
          Room/Details: Hall E

          For further information and press materials please visit http://www.merckgroup.com/media-center-oncology

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