Other pipeline developments discussed include a bladder cancer test, a male infertility assay, and the first oral dosage treatment for hypogonadism.
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.
Combination bladder Ca treatment yields positive phase II results
A phase II trial of apatorsen in combination with docetaxel yielded positive results in a final analysis, according to OncoGenex Pharmaceuticals, Inc. Apatorsen is designed to reduce the production of heat shock protein 27 to disable the defense mechanisms of cancer cells from developing resistance to treatment. The study, performed at 28 sites across the United States, enrolled 200 patients with metastatic bladder cancer who had progressed following first-line platinum-based chemotherapy. Researchers found that patients who received the apatorsen combination treatment experienced a 20% decrease in risk of death compared to the patients who were receiving just docetaxel. The primary analysis was a superiority test of overall survival, performed at a one-sided 0.10 significance level using a stratified log-rank test.
First patient dosed with oral treatment for hypogonadism
Diurnal Group, plc has successfully dosed the first patient in a phase I clinical trial of native oral testosterone formulation (DITEST) to treat hypogonadism. The study will focus on pharmacokinetics, safety, and tolerability of the formulation. The effects will be studied in a randomized trial in 24 adult males with primary or secondary hypogonadism with a primary endpoint comparing the rate and extent of absorption of testosterone from a single dose of DITEST with a single dose of testosterone undecanoate, 80 mg. The secondary endpoints will measure the impact of food on the rate and extent of absorption of testosterone from DITEST and compare the safety and tolerability of two different dosage levels. Data are expected to be available in mid-2017.
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