Title Lead Author Abstract # Presentation Date /Time (All times EDT) --- BAVENCIO (avelumab) --- Oral Session --- Maintenance avelumab T Powles Accepted for Plenary Session, + best supportive 100 phase 3 trial Sunday, May 31 at 1 p.m. care (Ave + BSC) vs BSC alone after platinum-based first-line (1L) chemotherapy (CTx) in advanced urothelial carcinoma (aUC): results from the JAVELIN Bladder LBA1 Abstract available online at the ASCO Meeting Library from Thursday, May 28 at 5 p.m. --- Poster Presentation --- Association of ASCO Meeting Library, Wednesday, May neutrophil to 13 at 5 p.m. lymphocyte ratio (NLR) with efficacy from JAVELIN Renal 101 MA Bilen 5061 --- Tepotinib --- Poster Presentation --- Tepotinib in patients ASCO Meeting Library, Wednesday, May (pts) with NSCLC 13 at 5 p.m. with MET exon 14 (METex14) skipping: health-related quality of life (HRQoL) (VISION PRO) PK Paik 9575 --- Primary efficacy and ASCO Meeting Library, Wednesday, May biomarker analyses 13 at 5 p.m. from the VISION study of tepotinib in patients (pts) with NSCLC with METex14 skipping X Le 9556 --- Bintrafusp Alfa --- Poster Presentation --- Two-year follow-up ASCO Meeting Library, Wednesday, May of bintrafusp alfa, 13 at 5 p.m. a bifunctional fusion protein targeting TGF- and PD-L1, for second- line (2L) treatment of non-small cell lung cancer (NSCLC) L Paz-Ares 9558 --- DDRi --- Poster Presentation --- A multicenter Phase ASCO Meeting Library, Wednesday, May Ib/II study of DNA- 13 at 5 p.m. PK inhibitor peposertib (formerly M3814) in combination with capecitabine and radiotherapy in patients with locally advanced rectal cancer P Romesser TPS4117 ---
About BAVENCIO( )(avelumab)
BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.(10-12) In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.
BAVENCIO Approved Indications
The European Commission has authorized the use of BAVENCIO in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). In September 2017, the European Commission granted conditional marketing authorization for BAVENCIO as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).
In the US, BAVENCIO in combination with axitinib is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Additionally, the US Food and Drug Administration (FDA) granted accelerated approval for avelumab (BAVENCIO()) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
BAVENCIO is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.
BAVENCIO Safety Profile from the EU Summary of Product Characteristics (SmPC)
The special warnings and precautions for use for BAVENCIO monotherapy include infusion-related reactions, as well as immune-related adverse reactions that include pneumonitis and hepatitis (including fatal cases), colitis, pancreatitis (including fatal cases), myocarditis (including fatal cases), endocrinopathies, nephritis and renal dysfunction, and other immune-related adverse reactions. The special warnings and precautions for use for BAVENCIO in combination with axitinib include hepatotoxicity.
The SmPC list of the most common adverse reactions with BAVENCIO monotherapy in patients with solid tumors includes fatigue, nausea, diarrhea, decreased appetite, constipation, infusion-related reactions, weight decreased and vomiting. The list of most common adverse reactions with BAVENCIO in combination with axitinib includes diarrhea, hypertension, fatigue, nausea, dysphonia, decreased appetite, hypothyroidism, cough, headache, dyspnea, and arthralgia.
About ERBITUX() (cetuximab)
ERBITUX() is an 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. Based on in vitro evidence, ERBITUX() also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells (antibody-dependent cell-mediated cytotoxicity [ADCC]).
ERBITUX() has already obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX(), a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998.
All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe [http://www.merckgroup.com/subscribe] to register online, change your selection or discontinue this service.
About Merck
Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices - the company is everywhere. In 2019, Merck generated sales of EUR 16.2 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.
Media contact:julissa.viana@emdserono.com[mailto:julissa.viana@emdserono.com]Phone: +1-781-206-5795
Logo : https://mma.prnewswire.com/media/1136775... [https://mma.prnewswire.com/media/1136775...]
