The FDA on Monday lifted a partial clinical hold on a Phase 3 lung cancer study run by Merck and Daiichi Sankyo. Regulators had placed the hold just last month after seeing a “higher than
anticipated incidence” of deaths from interstitial lung disease. To rectify things, Merck and Daiichi Sankyo took a number of steps — updating their trial’s exclusion criteria, more frequently reviewing unblinded datasets, and updating investigator training, a Daiichi spokesperson told Endpoints. “Once training is complete, enrollment of new patients into the trial will resume,” the spokesperson said. The study in question, IDeate-Lung02, is examining a
program known as ifinatamab deruxtecan, or I-DXd, in relapsed small cell lung cancer. I-DXd is a B7-H3 antibody-drug conjugate that’s part of Merck and Daiichi’s $4 billion deal, which was signed in 2023. |