Presentation date/time Title Lead author Abstract # (CEST) Location September 1 Sevilla M6620 (VX-970) Telli M.L. 242PD 09:15 - 10:45 auditorium Poster session Initial results of a phase 1 dose expansion cohort of M6620 (VX-970), a first-in-class ATR inhibitor, in combination with cisplatin (Cis) in patients (pts) with metastatic triple-negative breast cancer (mTNBC) (NCT02157792)
Presentation Date / Time Title Lead Author Abstract # (CEST) Location M2698 Poster session September 9 Alicante Phase I dose Tsimberidou A.M. 370PD 16:30-18:00 auditorium escalation study of M2698, a p70S6K/AKT inhibitor, in patients with advanced cancer September 11 Pharmacodynamic Xiong W. 393P 13:15-14:15 Hall 8 (PD) biomarkers for the p70S6K/Akt inhibitor, M2698: translation from animal to human and its relevance for dosing rationale
Presentation Date / Time Title Lead Author Abstract # (CEST) Location Erbitux(R): Poster session September 9 Biomarker testing Aravantinos G. 576P 13:15-14:15 Hall 8 practices in the SECURE (proSpective obsErvational clinical practiCe stUdy in the first-line management of metastatic colorectal cancer [mCRC] with eRbitux in combination with chemothErapy) study September 9 Quality of life Liu T. 593P 13:15-14:15 Hall 8 (QoL) analyses in patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC) treated with first-line FOLFOX-4 plus or minus cetuximab in the phase 3 TAILOR trial September 10 ENCORE: a phase 4 Le Tourneau C. 1068P 13:15-14:15 Hall 8 observational study of cetuximab and platinum-based therapy (PBT) for the first-line treatment of patients with recurrent/metastat ic squamous cell carcinoma of the head and neck (R/M SCCHN) September 10 A survey of Tischer B. 1579P 13:15-14:15 Hall 8 patient acceptance of skin toxicities from cetuximab-based therapy
Presentation Date / Time Title Lead Author Abstract # (CEST) Location Tepotinib Poster session September 9 Final data from a Qin S. 701P 13:15-14:15 Hall 8 phase Ib trial of tepotinib in Asian patients with advanced hepatocellular carcinoma (HCC)
Presentation Date / Time Title Lead Author Abstract # (CEST) Location Anti-PD-L1/TGF-b trap pathways Poster session September 11 Analysis of Zhang Y. 1645P 13:15-14:15 Hall 8 programmed death-ligand 1 (PD-L1) expression, transforming growth factor (TGF)-beta gene expression signatures (GES) and tumor-infiltrating immune cells (IC) in hepatocellular carcinoma (HCC): rationale for targeting PD-L1- and TGF-beta
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 KGaA, Darmstadt, Germany and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.
**Indications in the US
The U.S. 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. 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. Avelumab is not approved for any indication in any market outside the U.S.
Important Safety Information
The warnings and precautions for avelumab (BAVENCIO(R)) 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 for mMCC and patients with locally advanced or metastatic UC include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash.
About Erbitux(R) (cetuximab)
Erbitux(R) 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. Erbitux also targets cytotoxic immune effector cells towards EGFR expressing tumor cells (antibody dependent cell-mediated cytotoxicity, ADCC).
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