Darzalex Solid Tumor And PD-(L)1 Combo Future Dashed

Janssen Biotech Inc. has halted a Phase Ib/II study of the marketed multiple myeloma drug Darzalex (daratumumab) in combination with Roche's PD-L1 inhibitor Tecentriq (atezolizumab) in non-small cell lung cancer, on the recommendation of the Data Monitoring Committee (DMC). The company has also stopped a Phase I study of the CD38-targeting antibody with an in-house PD-1 inhibitor in multiple myeloma, and is in touch with other partners to discuss ceasing enrollment and dosing of other studies combining Darzalex with anti-PD-(L)1 agents while the data are being investigated. Health authorities have also been informed.

The CALLISTO/LUC2001 trial of Darzalex and Tecentriq was stopped after the DMC noted both a lack of benefit and increased mortality-related events in the combination treatment arm versus Tecentriq monotherapy....