Lilly/Innovent Experience Show Hurdles Remaining For Chinese PD-1 Inhibitors

 
• By Alaric DeArment
  
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China has fielded several homegrown checkpoint inhibitors, using lower cost as an argument for the US market, but sintilimab – a key test case – has underscored FDA skepticism.

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ODAC voted 14-1 to recommend an additional trial for Lilly/Innovent PD-1 inhibitor sintilimab • Source: Shutterstock

As concern mounted about the regulatory chances for Eli Lilly and Company/Innovent Biologics, Inc.’s PD-1 inhibitor sintilimab, Lilly tried to tap into the argument that more PD-1/L1 inhibitors could drive down costs for a class of drugs seeing wider and wider use. But a negative vote from the US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) suggests that the entire wave of China-developed PD-1/L1 inhibitors will face the same regulatory obstacles.

The FDA has been reluctant to rely on data from China-only studies, like Lilly/Innovent’s Phase III ORIENT-11 trial in non-small...

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