Daiichi Sankyo voluntarily placed a partial recruitment and enrollment hold on the phase III IDeate‑Lung02 study of the antibody‑drug conjugate ifinatamab deruxtecan following a higher‑than‑anticipated incidence of grade 5 interstitial lung disease (ILD) events. The hold was disclosed as patient deaths prompted an internal safety review. The pause affects recruitment and may delay timelines for regulatory submissions or approvals if investigators and regulators demand additional mitigation measures, revised monitoring, or amended inclusion criteria. ADCs carry known pulmonary toxicity risks; sponsors increasingly incorporate ILD surveillance strategies, but phase III safety signals can materially change development paths. Developers, investors and clinicians will monitor the investigation’s outcome, any changes to informed consent, and potential impacts on related ADC programs.
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