Applied Clinical Trials Digital Edition - July 2010

In the POTOMAC study, one year of treatment with Imfinzi (durvalumab) plus standard-of-care BCG induction and maintenance therapy showed a meaningful improvement in disease-free survival.

In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.

Updated results from the Phase III ELATIVE trial reveal Iqirvo (elafibranor) significantly reduced fatigue in patients with primary biliary cholangitis, with effects independent of pruritus and supported by proteomic data.

Topline results from the Phase III DESTINY-Breast11 trial show that Enhertu (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab, and pertuzumab significantly improves pathologic complete response rates compared to anthracycline-based standard-of-care regimens in the neoadjuvant treatment of high-risk, locally advanced HER2-positive early-stage breast cancer.

JNJ-1900 (NBTXR3), a novel, potentially first-in-class oncology therapy, demonstrated a median overall survival of 23 months from date of diagnosis as well as a favorable safety profile.