Publicado 09/10/2018 8:02:07CET
Title Lead Author Abstract # Presentation Location Date / Time (CEST) Erbitux Poster Sessions Association of L Miller-Phillips 124P Sat, Oct 20, Hall A3 - microRNA-21 12:30 - 1:30 PM Poster Area (miR-21) with Networking Hub efficacy of cetuximab (cet) and bevacizumab (bev) in patients with metastatic colorectal cancer (mCRC) within the FIRE-3 study (AIO KRK-0306) Retrospective RAS A Sobrero 484P Sun, Oct 21, Hall A3 - analysis of the 12:45 - 1:45 PM Poster Area EPIC trial: Networking Hub Cetuximab plus irinotecan versus irinotecan alone in patients with third- and further-line metastatic colorectal cancer Factors DP Modest 509P Sun, Oct 21, Hall A3 - influencing 12:45 - 1:45 PM Poster Area conversion to Networking Hub resectability and survival after resection of metastases in RAS WT metastatic colorectal cancer (mCRC): analysis of FIRE-3- AIOKRK0306 Initial report of E Oki 493P Sun, Oct 21, Hall A3 - a phase I/II study 12:45 - 1:45 PM Poster Area of S-1 and Networking Hub irinotecan (IRIS) in combination with cetuximab in patients with wild-type (wt) RAS metastatic colorectal cancer miR-31 as a Y Gaston-Mathé 521P Sun, Oct 21, Hall A3 - prognostic and 12:45 - 1:45 PM Poster Area predictive marker Networking Hub of disease-free survival (DFS) in resected stage III colon cancer: a retrospective analysis of the PETACC-8 trial Targeted therapies BC Xing 510P Sun, Oct 21, Hall A3 - in conversion 12:45 - 1:45 PM Poster Area therapy in mCRC: A Networking Hub systematic review and meta-analysis Phase II study of H Osawa 481P Sun, Oct 21, Hall A3 - cetuximab 12:45 - 1:45 PM Poster Area rechallenge in Networking Hub patients with RAS wild-type metastatic colorectal cancer: E-rechallenge trial Prospective X García-Albéniz 486P Sun, Oct 21, Hall A3 - biomarker study in 12:45 - 1:45 PM Poster Area advanced RAS Networking Hub wild-type colorectal cancer. POSIBA trial. (GEMCAD 10-02) Cetuximab + C Le Tourneau 1057P Sun, Oct 21, Hall A3 - platinum-based 12:45 - 1:45 PM Poster Area therapy (PBT) as a Networking Hub first-line treatment for patients with recurrent/metastat ic squamous cell carcinoma of the head and neck (R/M SCCHN): an observational study (ENCORE) Can concomitant J Dunst 1108P Sun, Oct 21, Hall A3 - diseases predict 12:45 - 1:45 PM Poster Area the compliance Networking Hub with cisplatin plus RT in patients with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN)? An exploratory endpoint analysis of the COMPLY trial Cetuximab in JC Ham 1068P Sun, Oct 21, Hall A3 - combination with 12:45 - 1:45 PM Poster Area methotrexate (MTX) Networking Hub as first-line treatment in recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN), a phase Ib - randomized phase II study versus single agent MTX Cetuximab in M Hecht 1064P Sun, Oct 21, Hall A3 - combination with 12:45 - 1:45 PM Poster Area platinum-based Networking Hub chemotherapy or radiotherapy in patients with recurrent and/or metastatic SSCHN in clinical routine: Updated interim results of the prospective SOCCER study Cetuximab in F Peyrade 1293P Sun, Oct 21, Hall A3 - patients with 12:45 - 1:45 PM Poster Area unresectable Networking Hu cutaneous squamous cell carcinoma is safe and effective - A real-life analysis
Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab 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, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models. - Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via 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.
Avelumab is currently being evaluated in the JAVELIN clinical development program, which involves at least 30 clinical programs, including seven Phase III trials, and more than 8,600 patients across more than 15 different tumor types. For a comprehensive list of all avelumab trials, please visit clinicaltrials.gov.
Approved Indications in the US
The US Food and Drug Administration (FDA) granted accelerated approval for avelumab (BAVENCIO(R)) 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.
Important Safety Information from the US FDA Approved Label
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 BAVENCIO for mMCC and patients with locally advanced or mUC include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash.
M7824 is an investigational bifunctional immunotherapy that is designed to bring together a TGF-beta trap and 'fuse' it with the anti-PD-L1 mechanism. M7824 is designed to simultaneously block the two immunosuppressive pathways - targeting both pathways aims to control tumor growth by potentially restoring and enhancing anti-tumor responses. M7824 is currently in Phase I studies for solid tumors.
Tepotinib (MSC2156119J) is an investigational, oral MET inhibitor that is thought to inhibit oncogenic MET receptor signaling caused by MET (gene) alterations, including both MET exon 14 skipping mutations and MET amplifications, or MET protein overexpression. It is a precision medicine and is designed to have a highly selective mechanism of action.
M6620 (previously known as VX-970) is an investigational small-molecule thought to inhibit ataxia telangiectasia and Rad3-related protein (ATR). ATR is believed to be a key sensor for DNA damage, activating the DNA damage checkpoint and leading to cell cycle arrest. Inhibition of ATR could potentially enhance the efficacy of DNA-damaging agents, but is also being investigated as a monotherapy against tumors with high levels of replication stress induced by overexpression of oncogenes.
M3814 is an investigational small-molecule which is thought to inhibit DNA-dependent protein kinase (DNA-PK). DNA-PK is a key enzyme for non-homologous end-joining (NHEJ), an important DNA double-strand break (DSB) repair pathway. Clinical studies investigating combinations of M3814 with other commonly used DNA-damaging agents such as radiotherapy and chemotherapy are underway.
M7583 is an investigational therapy that is thought to be a highly selective covalent inhibitor of Bruton's tyrosine kinase (BTKi) designed to minimize off-target effects.
Abituzumab is an investigational pan-alphanu integrin inhibiting monoclonal antibody thought to show activity against alphavbeta1, 3, 5, 6 and 8 integrin heterodimers. Merck entered into a development agreement with the SFJ Pharmaceuticals Group for abituzumab in metastatic colorectal cancer (mCRC). This collaboration will allow Merck and SFJ to develop the potential of abituzumab in a targeted way, focusing on a patient population that may benefit from the treatment the most.
About Erbitux(R) (cetuximab)
Erbitux(R) is a 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).
The most commonly reported side effect with Erbitux is an acne-like skin rash. 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 100 countries world-wide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck (SCCHN). 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.
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