Abstract ID / Presentation Title Lead Author Poster No. Date / Time Session Oral Presentations Renal Cell Choueiri TK 4504 Monday, June 5 Genitourinary Carcinoma 8:00-11:00 a.m. (Nonprostate) Cancer (JAVELIN Renal 100) First-line avelumab + axitinib therapy in patients with advanced renal cell carcinoma: results from a phase 1b trial Poster Sessions Head and Neck Lee NY TPS6093 Monday, June 5 Head and Neck Cancer Cancer (TiP) 1:15-4:45 p.m. (JAVELIN Head and Neck 100) JAVELIN Head and Neck 100: a phase 3 trial of avelumab in combination with chemoradiotherapy (CRT) vs CRT for 1st-line treatment of locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) Lymphoma (TiP) Chen R TPS7575 Monday, June 5 Hematologic (JAVELIN DLBCL) 8:00-11:30 a.m. Malignancies-Lymphoma and Chronic Lymphocytic Phase 1b/3 study Leukemia of avelumab-based combination regimens in patients (pts) with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) Merkel Cell D'Angelo SP 9530 Saturday, June 3 Melanoma/Skin Cancers Carcinoma 1:15-4:45 p.m. (JAVELIN Merkel 200) First-line avelumab treatment in patients with metastatic Merkel cell carcinoma: preliminary data from an ongoing study Merkel Cell Shapiro I 9557 Saturday, June 3 Melanoma/Skin Cancers Carcinoma 1:15-4:45 p.m. (JAVELIN Merkel 200) Exploratory biomarker analysis in patients with chemotherapy- refractory metastatic Merkel cell carcinoma treated with avelumab Non-Small Cell Gulley JL 9086 Saturday, June 3 Lung Cancer-Non-Small Lung Cancer 8:00-11:30 a.m. Cell Metastatic (JAVELIN Solid Tumor) Exposure-response and PD-L1 expression analysis of second-line avelumab in patients with advanced NSCLC: data from the JAVELIN Solid Tumor trial Pan-Tumor Kelly K 3059 Monday, June 5 Developmental (JAVELIN Solid 8:00-11:30 a.m. Therapeutics- Tumor) Immunotherapy Safety profile of avelumab in patients with advanced solid tumors: a JAVELIN pooled analysis of phase 1 and 2 data Prostate Cancer Fakhrejahani F 5037 Monday, June 5 Genitourinary (JAVELIN Solid 1:15-4:45 PM (Prostate) Cancer Tumor) Avelumab in metastatic castration-resist ant prostate cancer (mCRPC) Renal Cell Choueiri TK TPS4594 Sunday, June 4 Genitourinary Carcinoma 8:00-11:30 a.m. (Nonprostate) (JAVELIN Renal 101) Avelumab plus axitinib vs sunitinib as first-line treatment of advanced renal cell carcinoma: phase 3 study (JAVELIN Renal 101) Urothelial Apolo AB 4528 Sunday, June 4 Genitourinary Carcinoma 8:00-11:30 a.m. (Nonprostate) Cancer (JAVELIN Solid Tumor) Updated efficacy and safety of avelumab in metastatic urothelial carcinoma: pooled analysis from 2 cohorts of the phase 1b JAVELIN Solid Tumor study Publications Merkel Cell Bharmal M e21070 Carcinoma (JAVELIN Merkel 200) Non-progression during avelumab treatment is associated with clinically relevant improvements in health-related quality of life in patients with Merkel cell carcinoma Merkel Cell Kaufman HL e21065 Carcinoma (JAVELIN Merkel 200) Patient experiences with avelumab vs chemotherapy for treating Merkel cell carcinoma: results from protocol-specified qualitative research Non-Small Cell Feng Z e20581 Lung Cancer (JAVELIN Solid Tumor) Comparative study of two PD-L1 expression assays in patients with non-small cell lung cancer (NSCLC)
| Avelumab | is | under | clinical | investigation | for | treatment | of | NSCLC, | RCC, | DLBCL, | SSCHN | and | mCRPC | and | has | not | been | demonstrated | to | be | safe | and | effective | for | these | indications. | There | is | no | guarantee | that | avelumab | will | be | approved | for | NSCLC, | RCC, | DLBCL, | SSCHN | and | mCRPC | by | any | health | authority | worldwide |
About Avelumab
Avelumab is a human antibody specific for a protein called PD-L1, or programmed death ligand-1. Avelumab is designed to potentially engage both the adaptive and innate immune systems. By binding to PD-L1, avelumab is thought to prevent tumor cells from using PD-L1 for protection against white blood cells, such as T-cells, exposing them to anti-tumor responses. Avelumab has been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.
Indications
The US Food and Drug Administration (FDA) granted accelerated approval for avelumab (BAVENCIO(R)) for the treatment of (i) metastatic Merkel cell carcinoma (mMCC) in adults and pediatric patients 12 years and older and (ii) patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab is not approved for any indication in any market outside the US.
Important Safety Information
The warnings and precautions for BAVENCIO include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions), infusion-related reactions and embryo-fetal toxicity.
Common adverse reactions (reported in at least 20% of patients) in patients treated with avelumab include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash.
About the Merck-Pfizer Alliance
Immuno-oncology is a top priority for Merck and Pfizer Inc. The global strategic alliance between Merck and Pfizer enables the companies to benefit from each other's strengths and capabilities and further explore the therapeutic potential of avelumab, an anti-PD-L1 antibody initially discovered and developed by Merck. The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer's PD-1 antibody. The alliance is focused on developing high-priority international clinical programs to investigate avelumab as a monotherapy, as well as in combination regimens, and is striving to find new ways to treat cancer.
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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 2016, Merck generated sales of EUR 15.0 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 except in the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.
Pfizer Inc.: Working together for a healthier world(R)
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.pfizer.com. In addition, to learn more, please visit us at http://www.pfizer.com and follow us on Twitter at @Pfizer [http://cts.businesswire.com/ct/CT?id=sma... ] and @Pfizer_News [http://cts.businesswire.com/ct/CT?id=sma... ] , LinkedIn [https://www.linkedin.com/company/pfizer ], YouTube and like us on Facebook at Facebook.com/Pfizer [http://cts.businesswire.com/ct/CT?id=sma... ] .
Pfizer Disclosure Notice
The information contained in this release is as of May 17, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
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