Date: 2015-04-20
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Pfizer (USA - NY) Merck KGaA (Germany)
Product: avelumab (MSB0010718C)
Action
mechanism: monoclonal antibody/immune checkpoint inhibitor. MSB0010718C (avelumab) is a fully human IgG1 monoclonal antibody that binds to the PD-L1 (programmed death-ligand 1) protein, which is present at high levels in many cancer types. By competitively blocking the interaction with PD-1 receptors, it is believed that MSB0010718C thereby restores anti-tumor T-cell responses and inhibits tumor growth.
Disease: stage IIIb/IV non-small cell lung cancer
Therapeutic area: Cancer - Oncology
Country: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Republic of Korea, Mexico, Peru, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey, UK, USA
Trial
details: 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. (NCT02395172)
Latest
news: * On April 20, 2015, Merck KGaA and Pfizer announced the initiation and first patient treated in the international Phase III study (EMR 100070-004) designed to assess the efficacy and safety of anti-PD-L1 antibody, 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. This study is the first of several registration trials expected to start in 2015 for the alliance between Merck KGaA, and Pfizer. 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. 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. The companies will collaborate on up to 20 high priority immuno-oncology clinical development programs, including combination trials, many of which are expected to commence in 2015.
