Case Study: a leading pharmaceutical company validates surrogate endpoints for NSCLC with Certara CODEx

Repurposing Data & Advanced Analytics to Validate Surrogate Endpoints

The leading pharmaceutical company was developing a novel cancer drug and faced a challenge in validating progression-free survival or overall response rate as surrogate endpoints for overall survival in non-small cell lung cancer. Issues like cross-over between trial arms and pseudo-progression complicated this validation. They engaged Certara to address this challenge.

Certara utilized its CODEx platform, a web-based graphical interface, to perform an exploratory analysis on a large database of over 1,000 clinical trials. This analysis, which used advanced joint modeling techniques, revealed that surrogacy strength significantly improved, with the adjusted R2 correlation coefficient increasing to 0.47. The solution provided the client with valuable insights and a more effective surrogate modeling strategy, characterized by narrower prediction intervals for greater certainty.