Daiichi Sankyo and MSD's B7-H3-targeting antibody-drug conjugate (ADC) ifinatamab deruxtecan has received US Breakthrough Therapy designation (BTD) for platinum-refractory extensive-stage small cell lung cancer (SCLC). The decision was based on Phase II IDeate-Lung01 trial data showing clinically meaningful responses in this aggressive malignancy with 15% five-year survival rates. Full results will be presented at the 2025 World Conference on Lung Cancer (WCLC).

The ADC uses Daiichi's proprietary DXd platform to deliver a topoisomerase I inhibitor payload to tumours overexpressing B7-H3, an immune checkpoint protein linked to poor prognosis. It represents the first BTD achieved under Daiichi's 2023 global collaboration with MSD, which covers three ADCs across multiple cancers. Ifinatamab deruxtecan also holds orphan drug status in the US, EU, Japan and Taiwan for SCLC, with ongoing trials in squamous non-small cell lung cancer (NSCLC) and prostate cancer.

PharmCube's NextBiopharm® database lists 198 active B7-H3 projects worldwide, among which ADC is the most commonly used modality. Click here to request a free trial for NextBiopharm®.