Data from mUC combination therapy suggests efficacy, safety
Bristol-Myers Squibb recently presented data from its phase I/II open-label CheckMate-032 trial investigating two combination schedules of nivolumab (Opdivo) plus ipilimumab (Yervoy) in patients with metastatic urothelial carcinoma (mUC). The study included 208 mUC patients who received one or more prior lines of platinum-based therapy. The primary endpoint in this preliminary data confirmed an objective response rate (ORR) of 38.5% in patients who received nivolumab, 1 mg/kg, plus ipilimumab 3 mg/kg, compared to 26.0% in those receiving nivolumab, 3 mg/kg, plus ipilimumab, 1 mg/kg. The incidence of Grade 3-4 treatment-related adverse events was 30.8% in the group given nivolumab, 1 mg/kg, plus ipilimumab, 3 mg/kg, and 31.7% in the group receiving nivolumab, 3 mg/kg, plus ipilimumab, 1 mg/kg. Treatment-related adverse events led to discontinuation of therapy in 7.7% of patients in the nivolumab, 1 mg/kg, plus ipilimumab, 3 mg/kg group, and 13.5% in the group receiving nivolumab, 3 mg/kg, plus ipilimumab 1 mg/kg.
Bladder cancer test shows 99% negative predictive value
MDxHealth SA has announced that The Journal of Urology has published a second clinical validation study demonstrating performance of AssureMDx for Bladder Cancer, its urine-based epigenetic test. The test is a noninvasive DNA methylation and mutation test designed to improve the identification of patients who are at a higher risk for bladder cancer. In the 200-patient study in Europe, voided urine samples were collected from hematuria patients who were undergoing cystoscopy. Researchers analyzed the samples using AssureMDx biomarkers to identify an association between clinical risk variables. The study showed that AssureMDx can provide an overall negative predictive value of 99%, based on the 5%-10% prevalence of bladder cancer in patients with hematuria. The authors believe that utilization of the test could potentially result in a 77% reduction in diagnostic cystoscopies.
Data demonstrate clinical utility of male infertility assay
Clinical data regarding the infertility diagnosis platform, MiOXSYS, has been published in the scientific journal, Reproductive BioMedicine Online, Aytu Bioscience, Inc. announced. The article discusses how researchers used MiOXSYS to compare the semen of control volunteers with that of intertitle patients for signs of oxidative stress. Researchers measured static oxidation-reduction potential (sORP) and found a significant difference between the control volunteers (1.59±0.29 mV/106 sperm/mL) and the infertile volunteers (6.22±1.10 mV/106sperm/mL), suggesting that as sORP increases, fertility levels decline proportionally.