IDDI & Roche Identify DFS As Way Forward In Early Breast Cancer
IDDI’s findings suggest that it is appropriate to use disease-free survival (DFS) as a surrogate for overall survival (OS) in trials in HER-2-positive, early breast cancer.
Although frequently used as a primary endpoint, DFS has not been formally validated as a surrogate for OS in early breast cancer. Roche Germany commissioned IDDI to investigate this issue in the specific group of HER2-positive breast cancer.
IDDI conducted a literature review and secured data from the relevant clinical trials, which were then used in a meta-analysis that confirmed that DFS can indeed be used as primary endpoint, because it has sufficiently high correlation with OS in this situation.
The results were published in Lancet Oncology (Lancet Oncol 2019; 20: 361–70), a prestigious journal in the field of oncology, and were also the subject of an accompanying editorial in the same issue of the journal.
IDDI has long-standing experience in the challenging statistical issues that characterize the identification and validation of biomarkers of diagnostic utility, prognostic and/or predictive ability, and those that can potentially be used as surrogate endpoints in clinical trials.
Learn more at www.IDDI.com
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In 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.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
