New endpoints for early-stage cancer are gaining regulatory traction

Using the standard regulatory endpoints of overall survival (OS) and progression-free survival (PFS) may not be feasible in some early-stage cancer trials due to the time it would take to reach the number of patient deaths and disease progression events to demonstrate efficacy. Novel endpoints that can offer quicker insights into the short- or long-term clinical benefits of new cancer drugs are needed, especially for early-stage cancer and immediately before (neoadjuvant) and after (adjuvant) primary treatment. This article covers three promising new endpoints.


Open PDF

Return to Insights Center

Related Insights

Related Insights

Webinar

Navigating the complexities of AML drug development

Oct 30, 2024

Blog

PD-1 inhibitors face scrutiny in esophageal cancer: Key takeaways for drug developers

Oct 4, 2024

Article

Q&A Project Optimus: What you need to know

Oct 11, 2022

Webinar

Advancing mRNA-based drug development and vaccine manufacturing

Jul 1, 2024

Article

Five strategies for meeting the requirements of Project Optimus and improving the chances of approval

Nov 10, 2022

Blog

Making cell and gene therapy more accessible in the treatment of solid tumors

Jun 4, 2024

Show more