Boehringer Ingelheim GmbH, of Ingelheim, Germany, said it enrolled the first patient in a phase III study in patients with advanced colorectal cancer. The LUME-COLON 1 trial is a double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of nintedanib plus best supportive care (BSC) vs. placebo plus BSC, after previous treatment with standard chemotherapy and biological agents. More than 750 patients are expected to be enrolled. The co-primary endpoints will be progression-free survival and overall survival, while secondary endpoints include tumor response rate and disease control rate. Nintedanib, an oral kinase inhibitor, recently gained FDA approval as Ofev for idiopathic pulmonary fibrosis. (See BioWorld Today, Oct. 17, 2014.)
Takeda Pharaceutical Co. Ltd., of Osaka, Japan, and Sunovion Pharmaceuticals Inc., of Marlborough, Mass., reported data from several studies at the European College of Neuropsychopharmacology meeting in Berlin, including data showing that the use of Latuda (lurasidone), an atypical antipsychotic for adults with schizophrenia, reduced the risk of patients developing metabolic syndrome in a long-term study. Among patients without metabolic syndrome at baseline, after 12 months of treatment, the risk of developing metabolic syndrome was reduced by 48 percent in those treated with Latuda relative to patients treated with risperidone. Data from an open-label extension study in adults switching medication, showed that Latuda was well tolerated and was associated with a mean change in weight of -2.9 kg for those switching from risperidone and a -0.6 kg mean weight for patients who continued on Latuda.