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
Unlock Commercial Growth through Data-Driven Patient and HCP Insights
May 2nd 2025Leveraging data-driven patient and healthcare provider (HCP) insights, including social drivers of health (SDOH), is essential for life sciences companies to continuously improve patient engagement and commercial success. Mark Rodgers, AVP of Commercial Analytics at Inovalon, discusses how identifying treatment milestones, assessing HCP performance, and segmenting patient populations using SDOH data can drive targeted strategies that improve healthcare outcomes and market access
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
