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Global & Strategic Partners Initiate Phase III Study with Avelumab in Patients with Stage IIIb/IV Non-Small Cell Lung Cancer

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Merck KGaA, Darmstadt, Germany, and Pfizer Inc, New York, US, today announced the initiation and first patient treated in the international Phase III study (EMR 100070-004) designed to assess the efficacy and safety of the investigational cancer immunotherapy avelumab (MSB0010718C), compared with docetaxel, in patients with stage IIIb/IV non-small cell lung cancer (NSCLC) who have experienced disease progression after receiving a prior platinum-containing doublet therapy.

The Phase III study is an open-label, multicenter, 1:1 randomized clinical trial where patients with stage IIIb/IV NSCLC will receive either avelumab or docetaxel, regardless of PD-L1 status. Approximately 650 patients will participate across 290 sites in more than 30 countries in North America, South America, Asia, Africa and Europe. In North America, clinical trials on behalf of Merck KGaA, Darmstadt, Germany, will be conducted by EMD Serono, the company's US and Canadian biopharmaceutical businesses. The study is part of the JAVELIN clinical trial program for avelumab.

The primary endpoint of the study is overall survival (OS) in patients with programmed death-ligand 1 positive (PD-L1+) stage IIIb/IV NSCLC who have experienced disease progression after receiving a prior platinum-containing doublet therapy. Secondary endpoints will be assessed across the entire study population regardless of PD-L1 status and include OS; overall response rate (ORR); progression-free survival (PFS); and patient-reported outcomes.

"New and innovative treatment strategies are urgently needed to improve overall survival for patients with NSCLC, and we are investigating avelumab as a potential treatment option for patients with this very difficult-to-treat disease," said Dr. Luciano Rossetti, Global Head of R&D of the biopharmaceutical business of Merck KGaA, Darmstadt, Germany. "The treatment of the first patient in the Phase III trial is an important milestone for our immuno-oncology alliance."

"This trial marks the first of several registration studies we are planning to initiate this year together, and underscores our commitment to accelerating the development of medications for patients with cancer," said Dr. Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer for Pfizer Oncology. "Through this alliance, we will have the opportunity to combine the promising anti-PD-L1 antibody, avelumab, with our combined portfolios of approved and investigational oncology therapies, which may provide an exciting opportunity to potentially broaden the use of immunotherapy for patients with cancer."

The JAVELIN clinical trial program also includes an international Phase II trial to investigate avelumab in patients with metastatic Merkel cell carcinoma; an international Phase I trial to investigate avelumab in patients with metastatic or locally advanced solid tumors, and a Phase I trial to investigate avelumab in Japanese patients with metastatic or locally advanced solid tumors with an expansion part in Asian patients with gastric cancer. The Phase I program for avelumab includes more than 840 patients treated across multiple tumor types, including NSCLC, breast cancer, gastric cancer, ovarian cancer, bladder cancer, melanoma and mesothelioma.

*Avelumab is the proposed International Nonproprietary Name (INN) for the anti-PD-L1 monoclonal antibody (MSB0010718C)

About Non-Small Cell Lung Cancer

Globally, lung cancer is the most common cause of cancer-related deaths in men and the second most common in women, responsible for almost twice as many deaths as both breast and prostate cancer combined1. NSCLC is the most common type of lung cancer, accounting for 85 to 90 percent of all lung cancers2. Locally advanced and metastatic disease account for approximately 35 to 40 percent3 and 70 percent4 of patients, respectively with NSCLC.

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 KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

JAVELIN Clinical Trial Program for Avelumab

JAVELIN is an expansive international clinical trial program exploring the use of PD-L1 inhibition with avelumab to treat multiple types of cancer. The JAVELIN clinical trial program includes a Phase III study designed to assess the efficacy and safety of avelumab compared with docetaxel in patients with stage IIIb/IV NSCLC who have experienced disease progression after receiving a prior platinum-containing doublet therapy; an international Phase II open-label multicenter trial to investigate the clinical activity and safety of avelumab in patients with metastatic Merkel cell carcinoma; an international Phase I open-label, multiple ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity in patients with metastatic or locally advanced solid tumors; and a Phase I trial to investigate the tolerability, safety, pharmacokinetics, biological, and clinical activity of avelumab in Japanese patients with metastatic or locally advanced solid tumors with an expansion part in Asian patients with gastric cancer.

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