On September 11, 2015 Merck reported that they will present new data on early- and latestage compounds from its refocused oncology and immuno-oncology pipeline, as well as Erbitux (cetuximab) data, at this year’s European Cancer Congress (ECC), held in Vienna, Austria, from September 25–29, 2015 (Press release, Merck KGaA, SEP 11, 2015, file:///C:/Users/dexter/Downloads/150911_ECC_CurtainRaiser_Erbitux_EN.pdf [SID:1234507465]).
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These data reinforce the company’s science-driven and patient-centric approach to developing new therapies that will help patients fight difficult-to-treat cancers such as pancreatic, non-smallcell lung and urothelial.
"Our data at ECC 2015 demonstrate our oncology strategy in action, through external innovation and a focus on precision medicine to personalize treatment," said Luciano Rossetti, Head of Global Research & Development at Merck’s biopharmaceutical business Merck Serono. "We are committed to understanding which patients will benefit most from our treatments, as this is a critical component to improve patient outcomes."
Collaborating to Address Patient Needs
Two important strategic collaborations presenting data in challenging cancers at ECC this year are the Merck–Pfizer Alliance, and Merck’s partnership with Threshold Pharmaceuticals, Inc.
The Merck–Pfizer Alliance will present six abstracts on studies evaluating the potential role of PD-L1 inhibition, and the safety and efficacy of the investigational cancer immunotherapy avelumab. New data on this immune checkpoint inhibitor will be presented in urothelial (e.g. bladder), mesothelioma and gastric/gastroesophageal cancers. Additional non-small cell lung and ovarian cancer data from Phase 1b trials build on those previously presented at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).1–10
Together with Threshold Pharmaceuticals Inc., Merck will present Phase I study data on evofosfamide (previously known as TH-302; an investigational hypoxia-activated prodrug) in Asian patients with advanced solid tumors and pancreatic cancer. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to evofosfamide, administered in combination with gemcitabine for the treatment of previously untreated patients with locally advanced unresectable or metastatic pancreatic cancer, and for the development of evofosfamide in combination with doxorubicin for the treatment of patients with locally advanced or metastatic soft tissue sarcomas.
Personalizing Treatment for Patients
Data presented at ECC this year will also highlight Merck’s focus on precision medicine with the aim to deliver personalized treatments for patients. This includes data for tepotinib, a selective small-molecule inhibitor of the c-Met receptor tyrosine kinase, in patients with advanced hepatocellular and non-small-cell lung cancer that overexpress c-Met. In addition, new subanalyses on the clinical value of Erbitux in the treatment of 1st line RAS wild-type metastatic colorectal cancer (mCRC), and of biomarkers in head and neck cancer will also be presented.
Cutting-Edge Diagnostics to Ensure Appropriate Treatment
Merck’s precision medicine research extends beyond treatment into collaborations to aid in the development of cutting-edge diagnostic tests that help physicians rapidly identify patients that will most likely benefit from specific treatments. Merck is collaborating with Sysmex Inostics on the development and commercialization of a liquid biopsy test for determining the RAS (KRAS and NRAS) tumor mutation status in mCRC patients. Sysmex will present data on the validity of the test, also referred to as a blood-based biomarker test, at ECC. The liquid biopsy RAS biomarker test is expected to receive its European Conformity approval (CE mark) this year. Currently it is applied for research use only (RUO) in a number of countries.
*Avelumab is the proposed International Nonproprietary Name (INN) for the anti-PD-L1 monoclonal antibody (MSB0010718C).
Accepted abstracts submitted by Merck and partners related to our products, our oncology and immuno-oncology pipeline are listed below. Abstracts are currently available on the ECC website.
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 U.S. and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas.
About Evofosfamide
Evofosfamide (previously known as TH-302) is an investigational hypoxia-activated prodrug that is thought to be activated under severe tumor hypoxic conditions, a feature of many solid tumors. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood vessel supply. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic. Evofosfamide is currently under evaluation in two Phase III trials: one in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable or metastatic soft tissue sarcoma (the TH-CR-406 trial), and the other in combination with gemcitabine versus gemcitabine and placebo in patients with locally advanced unresectable or metastatic pancreatic cancer (the MAESTRO trial). Both Phase III trials are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. The FDA and the European Commission have granted evofosfamide Orphan Drug designation for the treatment of STS and pancreatic cancer. The FDA has also granted Fast Track designation to evofosfamide for the treatment of pancreatic cancer and soft tissue sarcoma. Evofosfamide is also being investigated in a Phase II trial for the treatment of non-squamous non-small cell lung cancer, and in earlier-stage clinical trials of other solid tumors and hematological malignancies. Merck signed a global license and co-development agreement for evofosfamide with Threshold Pharmaceuticals, Inc. in February 2012, with an option for Threshold to co-commercialize in the U.S.
About Tepotinib
Tepotinib (also known as MSC2156119J or EMD1214063) is an investigational small-molecule inhibitor of the c-Met receptor tyrosine kinase that has been shown to cause growth inhibition and regression of tumors with c-Met mutations, c-Met overexpression or hepatocyte growth factor secretion in preclinical models. Tepotinib is currently under evaluation in Phase I/II trials.
About Avelumab
Avelumab (also known as MSB0010718C) 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 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.