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

Hopes for Genmab/Janssen's myeloma drug daratumumab in solid tumors have faded after the CALLISTO trial in combination with Roche's Tecentriq in NSCLC was halted for lack of benefit and increased mortality. The future is dim for Darzalex in combination with PD-(L)1 therapies in general.

ship wrecked
Darzalex has run aground in PD-(L)1 combos and solid tumors • Source: Shutterstock

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...

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