Ifinatamab back in play in US

After being hit with a global clinical hold late last year for the phase 3 Ideate-Lung02 study of its B7-H3-targeting ADC ifinatamab deruxtecan following fatal lung toxicity events, Daiichi Sankyo and Merck & Co are resuming the trial, at least in the US. The companies have found a way forward with the FDA by agreeing to tighter patient selection, excluding individuals at elevated risk of interstitial lung disease (ILD) or pneumonitis. Oversight is also being ramped up, with an independent data monitoring committee set to review unblinded safety and efficacy data more frequently, and feed those assessments directly to the agency. That progress, however, has yet to translate to Europe. The trial remains on hold in the EU, where the companies say they are continuing discussions with regulators. Separately, AstraZeneca's Tropion-Lung15 study, evaluating the Daiichi-originated TROP2 ADC Datroway, which was also halted during the second half of 2025 due to a spike in high-grade ILD events, has quietly resumed enrolment, according to clinicaltrials.gov. Both ADCs use the same payload. While Astra and Daiichi haven't made any comments about this trial, the restart suggests that mitigation measures are now sufficient to keep regulators comfortable.