Daiichi Sankyo and Merck Withdraw Application for Small Cell Lung Cancer Treatment

Daiichi Sankyo and Merck have voluntarily withdrawn their U.S. Biologics License Application (BLA) for ifinatamab deruxtecan, a potential treatment for adults with extensive-stage small cell lung cancer (ES-SCLC).

The decision follows discussions with the FDA, which indicated that available data supporting the application were not sufficient to support accelerated approval.

Results from the Phase 2 IDeate-Lung01 trial showed an objective response rate of 48.2% at a dose of 12 mg/kg, with a median duration of response of 5.3 months and overall survival of 10.3 months.

Despite this setback, Daiichi Sankyo and Merck plan to continue evaluating ifinatamab deruxtecan in ES-SCLC through the ongoing Phase 3 IDeate-Lung02 trial.