Applied Clinical Trials Digital Edition - February/March 2014

In the Phase II LUMINOSITY study, Emrelis (telisotuzumab vedotin-tllv), a first-in-class c-Met-directed antibody-drug conjugate, demonstrated an overall response rate of 35%.

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.

Decision follows underwhelming Phase II results from GALAXIES Lung-201 and H&N-202 trials, prompting iTeos and GSK to end development of the TIGIT-targeting antibody and halt enrollment in all ongoing belrestotug studies.

The REAL8 basket study showed Sogroya (somapacitan) was non-inferior to Norditropin (somatropin) in improving yearly growth rate.

Final overall survival results from the Phase III APHINITY trial show a 17% reduction in the risk of death at 10 years for patients with HER2-positive early-stage breast cancer treated with a Perjeta-based adjuvant regimen.