MSD and Daiichi Sankyo have announced that US regulators have accepted and granted priority review to the biologics licence application (BLA) for ifinatamab deruxtecan (I-DXd), a B7-H3-targeted antibody-drug conjugate (ADC), for the treatment of extensive-stage small cell lung cancer (ES-SCLC). If approved, this would be the first B7-H3 ADC on the market. The application marks the fourth ADC from Daiichi Sankyo to reach the BLA stage and the second for MSD, following the withdrawal of its HER3 ADC.

The submission is supported by positive data from the Phase II IDeate-Lung01 trial, in which the candidate demonstrated a confirmed objective response rate (ORR) of 48.2% and a median overall survival (mOS) of 10.3 months in the 12 mg/kg dose expansion cohort. The safety profile of I-DXd was consistent with prior studies, with the most common grade 3 or higher adverse events being neutropoenia, lymphopoenia and anaemia. Treatment-related interstitial lung disease (ILD) was observed in 12.4% of patients, with the majority of cases being low-grade. 

PharmCube's NextBiopharm® database shows that I-DXd leads a pack of 46 B7-H3 ADCs in development. Click here to request a free trial for NextBiopharm®.