Daiichi Sankyo and Merck Halt Development of B7-H3 ADC in Small-Cell Lung Cancer

Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. have made the decision to withdraw their BLA for ifinatamab deruxtecan (i-dxd), a B7-H3-directed antibody-drug conjugate, in the treatment of adults with extensive-stage small-cell lung cancer whose disease progressed on or after platinum-based chemotherapy.

The move comes as a voluntary withdrawal by the companies, marking a significant shift in their strategy for this particular asset. The BLA was initially submitted to the FDA for priority review, but it appears that further development of i-dxd will not be pursued at this time.