Publicado 23/09/2019 08:01CET
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New Data at ESMO 2019 for Merck Highlight Focused Clinical Development and Commitment to Patient Care (1)

Not intended for distribution in the USA, Canada or the UK

Key ESMO Abstracts #BAVENCIO() (avelumab): 1451; 3152; 4174; 4256; 4823; 5113, ERBITUX() (cetuximab): 1212, 2589, 4455, Tepotinib (MET kinase inhibitor): 3930; 5373; 5455, M6620 (ATR inhibitor): 1547, Combinations: 4062; 4934.

-- New subgroup analyses for first-line treatment of advanced renal cell carcinoma with BAVENCIO(*) (avelumab) in combination with axitinib -- Three-year overall survival data for patients treated first-line with ERBITUX( )(cetuximab) plus FOLFOX-4 in metastatic colorectal cancer -- Data across several therapeutic agents showcase progress of early- to late-stage pipeline, including tepotinib(**), and novel combinations

DARMSTADT, Germany, Sept. 23, 2019 /PRNewswire/ -- Merck, a leading science and technology company, today announced that new data representing several key therapeutic agents from its diverse oncology pipeline will be presented at the 2019 European Society for Medical Oncology (ESMO) Congress, September 27-October 1, in Barcelona, Spain.

Spanning multiple tumor types, data being presented include new evidence supporting approved treatments BAVENCIO(*) (avelumab) and ERBITUX() (cetuximab), and new research from Merck's early pipeline including novel combinations and the investigational targeted therapy tepotinib(**), recently granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) in patients with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations who progressed following platinum-based cancer therapy. In March 2018, tepotinib's potential was also recognized by the Japanese Ministry of Health, Labour and Welfare (MHLW), which granted SAKIGAKE 'fast-track' designation for tepotinib in advanced NSCLC harboring MET exon 14 skipping alterations.

"Our presence at ESMO underscores our commitment to research and development in highly focused areas within immuno-oncology, precision medicine and DNA damage response," said Luciano Rossetti, Global Head of Research & Development for the Biopharma business of Merck. "We believe that by applying cutting-edge science in our clinical programs we are getting closer to making a difference in patient outcomes."

New data for BAVENCIO( )will include two poster discussions from the Phase III JAVELIN Renal 101 study evaluating efficacy of first-line treatment with avelumab in combination with axitinib compared with sunitinib in two clinically relevant subgroups of patients with advanced renal cell carcinoma (RCC): those with sarcomatoid histology and those who did not undergo upfront cytoreductive nephrectomy. Results from JAVELIN Renal 101 supported the recent US FDA approval and the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for BAVENCIO() plus axitinib for first-line treatment of adult patients with advanced RCC.

ERBITUX() data further reinforce the impact of primary tumor location on three-year overall survival among patients from China with RAS wild-type metastatic colorectal cancer (mCRC) treated with first-line FOLFOX-4 with or without cetuximab from the Phase III TAILOR trial. Additionally, a pooled analysis of patient-level data explores the effect on overall survival of cetuximab in combination with chemotherapy dosed once every two weeks, compared with once-weekly dosing, for first-line treatment in patients with RAS wild-type mCRC. These two sets of results underscore the clinical benefit of cetuximab and add to the growing body of evidence supporting its role in combination with chemotherapy in first-line RAS wild-type mCRC.

New research will be presented from across the company's earlier pipeline, including a pooled analysis of safety data across Phase I and II studies in advanced solid tumors for the investigational oral MET inhibitor tepotinib.

A number of investigator-sponsored studies (ISS) and collaborative research studies (CRS) exploring Merck's pipeline will also be presented at this year's congress, including a late-breaking oral presentation on results from a randomized Phase II study of M6620(***), an investigational ataxia telangiectasia and rad3-related (ATR) kinase inhibitor from the company's comprehensive DNA Damage Response (DDR) portfolio, in combination with gemcitabine compared with gemcitabine alone in platinum-resistant high-grade serous ovarian cancer. The study is sponsored by the National Cancer Institute (NCI) under its Cooperative Research and Development Agreement with Merck for M6620, and these results are the first-ever randomized data to be presented for an ATR inhibitor.

*The combination of BAVENCIO() and axitinib is approved for the first-line treatment of advanced RCC only in the United States and Argentina. There is no guarantee that avelumab in combination with axitinib will be approved for RCC by any other health authority worldwide.

(**)Tepotinib is the recommended International Nonproprietary Name (INN) for the MET kinase inhibitor (MSC2156119J). Tepotinib is currently under clinical investigation and not approved for any use anywhere in the world.

(***)M6620 is currently under clinical investigation and not approved for any use anywhere in the world.

Notes to Editors

Key Merck, ISS and CRS abstracts scheduled for presentation are listed below.


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