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

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 cell lung cancer (NSCLC), and during its 10 February review ODAC voted 14-1 to recommend an additional trial –