Medarex, Inc. has announced preliminary data from an ongoing Phase 1 study of MDX-1106 (ONO-4538: development code of Ono Pharmaceutical Co., Ltd.), a fully human anti-PD-1 antibody.
Data presented from patients with recurrent or treatment-refractory cancer in the study included the safety, tolerability and pharmacokinetic profile of single-dose MDX-1106. In addition, preliminary evidence of anti-tumor activity was observed, including one patient with colorectal carcinoma who experienced a confirmed partial response that has been durable for more than 6 months. Tumor regressions (tumor shrinkage that did not meet the criteria for partial response) were also observed in four additional patients, including two patients with melanoma, one patient with non-small cell lung cancer, and one with renal cell carcinoma. These preliminary study results were presented in an oral presentation by investigator Julie Brahmer, M.D., Assistant Professor of Oncology from the Sidney Kimmel Cancer Comprehensive Center at Johns Hopkins University at the annual meeting of the American Society of Clinical Oncology (ASCO) being held in Chicago. (Abstract #3006)
"We are pleased with the safety profile and preliminary evidence of anti- tumor activity from this first human clinical trial of MDX-1106," said Geoffrey M. Nichol, MBChB, Senior Vice President of Product Development at Medarex. "We look forward to the further development of this novel immunotherapy, and plans are underway to initiate a Phase 2 trial of MDX-1106 in cancer this year."