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Innovent expands P3 lung cancer study

Innovent

28 Sept 2026

Innovent Biologics and partner Takeda Pharmaceuticals have received US FDA approval to expand its Phase 3 study (MarsLight-11) of IBI363/TAK-928 to include non-squamous non-small cell lung cancer (NSCLC) patients. Previously the study only included squamous NSCLC. The global, multicentre, randomised, Phase 3 is assessing efficacy and safety of IBI363 monotherapy vs docetaxel in patients with unresectable or metastatic NSCLC whose disease progressed under platinum-based chemo and anti-PD-1/PD-L1 therapy. IBI363 is an alpha-biased IL-2/PD-1 bispecific protein is a PD-1/PD-L1 antagonist and IL-2 agonist.

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