Date: 2015-12-09
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: unresectable, recurrent or metastatic adenocarcinoma of the stomach, or of the gastro esophageal junction
Therapeutic area: Cancer - Oncology
Country: Germany, USA
Trial
details: The purpose of this study is to demonstrate superiority of treatment with avelumab plus best supportive care (BSC) versus physician's choice (chosen from a pre-specified list of therapeutic options) plus BSC. (NCT02625623)
Latest
news: * On December 9, 2015, Merck KGaA and Pfizer announced the initiation of two Phase III studies of avelumab, an investigational, fully human anti-PD-L1 IgG1 monoclonal antibody, in treating advanced or metastatic gastric/gastro-esophageal junction (GEJ) cancers, which are aggressive cancers with poor survival rates. These pivotal trials are investigating avelumab in the first-line and third-line settings, with overall survival (OS) as the primary endpoint in both trials. The third-line study, JAVELIN Gastric 300, is a multicenter, international, randomized, open-label Phase III trial designed to evaluate the potential superiority (based on OS) of avelumab in patients with unresectable, recurrent or metastatic gastric/GEJ cancers, compared with investigator’s choice of chemotherapy from a pre-specified list of therapeutic options. The study will enroll approximately 330 patients, spanning approximately 170 sites in Asia, Australia, Europe, North America and South America. The clinical development program for avelumab now includes more than 1,500 patients who have been treated across more than 15 tumor types, including breast cancer, gastric/GEJ cancers, head and neck cancer, Merkel cell carcinoma, melanoma, mesothelioma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma and urothelial (e.g. bladder) cancer. Clinical trials for both of the gastric/GEJ Phase III trials in North America will be conducted on behalf of Merck KGaA, Darmstadt, Germany, by EMD Serono, the company’s US and Canadian biopharma business.
