ASCO Abstract # Avelumab: 4009, TPS4134, TPS4135, 9036, TPS9105, 3055, TPS3106, 8503, 4514, 4516, 5533, TPS5600, TPS4580, 9508; tepotinib: 4072

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1 Your Contact Gangolf Schrimpf ASCO Abstract Avelumab: 4009, TPS4134, TPS4135, 9036, TPS9105, 3055, TPS3106, 8503, 4514, 4516, 5533, TPS5600, TPS4580, 9508; tepotinib: 4072 May 18, 2016 Bringing Innovation to Patients: Merck Presents New Advances at ASCO 2016 Abstracts featuring Merck compounds span a broad range of cancers, with an emphasis on those which are difficult-to-treat and represent significant unmet patient need Avelumab data in seven different cancers from rapidly accelerating JAVELIN clinical program to be presented Darmstadt, Germany, May 18, 2016 Merck, a leading science and technology company, announced that this year s Annual Meeting of the American Society of Clinical Oncology (ASCO; June 3 7, 2016, Chicago, IL, U.S.) will feature research on Merck compounds across a broad range of cancers. These reports, which focus on cancers with significant unmet patient need, will inform and advance scientific knowledge within the oncology community. This includes data on avelumab*, Merck s high priority, late-stage investigational immuno-therapy, that is being developed in collaboration with Pfizer. We have a clear and focused commitment to accelerate oncology innovation and transform the way cancer is treated, both by leveraging our internal expertise and capabilities, and through our collaborations, said Luciano Rossetti, Executive Vice President, Head of Global Research & Development at the biopharma business of Merck. Avelumab is an example of this strategy coming to life, as it was originally discovered by Merck and is being co-developed with Pfizer. More broadly, we will be Page 1 of 6 Frankfurter Strasse Darmstadt Germany Hotline merckgroup.com Head Media Relations Spokesperson: / / Fax media.relations@merckgroup.com

2 presenting data across multiple tumor types at ASCO as we continue to advance our oncology and immuno-oncology pipeline. Collaborating to bring innovation to cancer patients Merck and Pfizer are presenting avelumab data at this year s congress that reflect the significant progress this alliance is making. This includes results from the pivotal, Phase II metastatic Merkel cell carcinoma trial which, taken together with data from other challenging tumors being evaluated in the JAVELIN clinical development program, supports clear clinical activity and safety signals for avelumab. Avelumab, an investigational, fully human, anti-programmed death-ligand 1 (PD-L1) monoclonal antibody, has a dual mechanism of action that is believed to enable the immune system to find and attack cancer cells. Avelumab s clinical program, one of the largest immuno-oncology development programs, now includes approximately 2,200 patients across more than 15 tumor types. Together, the two companies have initiated 30 ongoing monotherapy or combination therapy programs with avelumab, including nine pivotal studies. Innovation: treatment and beyond Erbitux and precision medicine remain a strategic priority for Merck. As a cornerstone of treatment in RAS wild-type mcrc and SCCHN, Merck is committed to exploring Erbitux as an anchor treatment in combination with immuno-therapies in these indications. Erbitux also continues to captivate the interest of leading researchers and the medical community with more than 30 abstracts at ASCO, the majority from investigator-led studies. Merck aims to improve patients experiences along their treatment journey by helping patients and physicians to make faster treatment decisions. Merck is the first pharmaceutical company to collaborate with multiple diagnostic companies to co-develop and commercialize innovative liquid biopsy RAS biomarker tests to determine which patients with mcrc would benefit from treatment with Erbitux. At ASCO, Merck s partner Sysmex Inostics will be presenting new data demonstrating the value of the co-developed and commercialized liquid biopsy test, which received CE mark approval earlier this year. Page 2 of 6

3 Truly innovative pipeline Following Merck s strategic reassessment of its portfolio, there is significant potential with later-stage priority programs and Merck s truly innovative early pipeline. Six out of seven of the current pipeline products in Phases I III were discovered in Merck s labs. Data will be presented on another of these Merck-discovered compounds, tepotinib**, an investigational, highly selective, small molecule inhibitor of the c-met receptor tyrosine kinase. The ASCO presentation will report on tepotinib s clinical activity and tolerability in Asian patients with advanced hepatocellular carcinoma, a cancer in which there is a considerable need for new treatment options. Through Merck s Translational Innovation Platforms in oncology and immunooncology, the company is developing differentiated therapeutic drugs targeting distinct cancer hallmarks and multiple immune-system-mediated mechanisms. These include, among others, DNA repair, antibody drug conjugates, oncogenes, tumor antigens, T-cell therapies, and targeted cytokines and chemokines. 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 and avelumab (not listed). Title Lead Author Abstract Avelumab advanced gastric or gastroesophageal junction cancer from the JAVELIN analysis of safety, clinical activity C Chung 4009 June 4 1) Page 3 of 6

4 Title Lead Author Abstract Avelumab (cont d) Maintenance therapy with avelumab (MSB C; anti-pd-l1) vs continuation of first-line chemotherapy in patients with unresectable, locally advanced or metastatic gastric cancer: the Phase III JAVELIN Gastric 100 trial anti-pd-l1) + best supportive care (BSC) vs BSC ± chemotherapy as third-line treatment for patients with unresectable, recurrent, or metastatic gastric cancer: the Phase III JAVELIN Gastric 300 trial anti-pd-l1) as a first-line treatment for patients with advanced NSCLC from the JAVELIN Solid Tumor Phase Ib trial: safety, clinical activity, and PD-L1 expression anti-pd-l1) vs platinumbased doublet as first-line treatment for metastatic or recurrent PD-L1 positive nonsmall-cell lung cancer: the Phase III JAVELIN Lung 100 trial advanced cancer: safety data from 1300 patients enrolled in the Phase Ib JAVELIN Solid Tumor trial anti-pd-l1) in combination with other cancer immunotherapies in patients with advanced malignancies: the Phase Ib/II JAVELIN Medley study advanced unresectable mesothelioma from the JAVELIN Solid Tumor Phase Ib trial: safety, clinical activity, and PD-L1 expression M Moehler TPS4134 June 4 Y-J Bang TPS4135 June 4 C Verschraegen 9036 June 4 M Reck TPS9105 June 4 K Kelly 3055 June 5 A Ribas TPS3106 June 5 R Hassan 8503 June 5 08:00 11:05 Lung Non- Small Cell Metastatic Lung Non- Small Cell Metastatic Developmental therapeutics Immunotherapy Developmental therapeutics Immunotherapy Oral Abstract : Lung Non- Small Cell Local- Regional/Small Cell/Other Thoracic s 124b) 125a) 359) 425a) 377) 422b) Arie Crown Theater Page 4 of 6

5 Title Lead Author Abstract Avelumab (cont d) metastatic urothelial carcinoma from the JAVELIN analysis of safety, clinical activity, and PD-L1 expression A Apolo 4514 June 6 Genitourinary (Nonprostate) A137) advanced adrenocortical carcinoma from the JAVELIN safety and clinical activity C Le Tourneau 4516 June 6 Genitourinary (Nonprostate) 138) recurrent/refractory ovarian cancer from the JAVELIN safety and clinical activity anti-pd-l1) ± pegylated liposomal doxorubicin vs pegylated liposomal doxorubicin alone in patients with platinumresistant/refractory ovarian cancer: the Phase III JAVELIN Ovarian 200 trial anti-pd-l1) in combination with axitinib as first-line treatment for patients with advanced renal cell carcinoma metastatic Merkel cell carcinoma previously treated with chemotherapy: results of the Phase II JAVELIN Merkel 200 trial M Disis 5533 June 6 E Pujade- Lauraine TPS5600 June 6 J Larkin TPS4580 June 6 H Kaufman 9508 June 6 13:15 16:15 Title Lead author Abstract Tepotinib Tolerability and activity of tepotinib in Asian patients with advanced hepatocellular carcinoma (HCC) S Qin 4072 June 4 Gynecologic Gynecologic Genitourinary (Nonprostate) Oral Abstract : Melanoma/Skin s 356) 421b) 199a) Arie Crown Theater 64) *Avelumab is the proposed nonproprietary name for the anti-pd-l1 mab (also known as MSB C). ** Tepotinib is the proposed nonproprietary name for the c-met kinase inhibitor (also known as MSC J). 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. Page 5 of 6

6 About Avelumab Avelumab (also known as MSB C) 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 potentially engage the innate immune system and induce antibody-dependent cell-mediated cytotoxicity (ADCC). In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab. About Erbitux Erbitux is a highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe. Erbitux has already obtained market authorization in over 90 countries world-wide for the treatment of colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck (SCCHN). Merck licensed the right to market Erbitux outside the US and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas. About Tepotinib Tepotinib (also known as MSC J) is an investigational small-molecule inhibitor of the c-met receptor tyrosine kinase capable of inhibiting both hepatocyte growth factor-dependent and -independent c-met activation in low nanomolar concentrations. 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. All Merck Press Releases are distributed by at the same time they become available on the Merck Website. Please go to to register online, change your selection or discontinue this service. 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 2015, Merck generated sales of 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. Page 6 of 6