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Foreign Data: Sintilimab’s Development Shows What Not To Do When Pursuing US Approval

 
• By Sue Sutter

The FDA’s concerns about conduct of ORIENT-11 trial include adequacy of informed consent, uncertainty about confidence in data generated in China, and failure of development partners Innovent and Eli Lilly to consult the US regulator about the study’s design.

Tennis racket
Innovent and Lilly seemingly committed some unforced errors in how they conducted the ORIENT trial and brought the results to the US FDA. • Source: Alamy

Companies seeking to get an application through the US Food and Drug Administration based primarily on data from China or any other single country or region would be wise to heed the agency’s criticisms about the design and conduct of the Phase III trial for Innovent Biologics, Inc./Eli Lilly and Company’s PD-1 inhibitor sintilimab.

Looking beyond the primary question of whether the ORIENT-11 study results were generalizable to the US, the agency raised a...

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