J&J terminates PD-(L)1 combo studies of cancer therapy Darzalex

pharmafile | May 29, 2018 | News story | Manufacturing and Production, Research and Development Cancer, Genmab, J&J, JJ, Johnson & Johnson, Roche, darzalex, multiple myeloma, tecentriq 

Johnson & Johnson is to terminate its studies investigating Genmab’s CD38-targeting, human IgG1κ monoclonal antibody Darzalex (daratumumab) in combination with Roche’s PD-L1 inhibitor Tecentriq (atezolizumab) in patients with previously treated non-small cell lung cancer.

The decision to scrap the Phase 1b/2 study was based on the advice of a review conducted by a data monitoring committee which found there was no benefit in pursuing further development of the combination, in addition to a “numerical increase in mortality-related events”. Darzalex’s action on CD38, a glycoprotein overexpressed by multiple myeloma, made it a key treatment in fighting the disease, and the move to halt its development in this key combination sent Genmab’s shares falling 20%.

Genmab also revealed that a 386-participant Phase 1 trial of Darzalex plus the anti PD-1 antibody JNJ- 63723283 in multiple myeloma patients will also be scrapped.

J&J partnered up with Genmab to commercialise the drug in 2012, and it was authorised in the US for the treatment of multiple myeloma in patients who have received three prior therapies in 2015.

“While we are disappointed that the studies will be discontinued, Genmab fully supports [Johnson & Johnson’s] decision as patient safety is paramount in drug development,” remarked Genmab CEO Jan van de Winkel. “We look forward to gaining a better understanding of the data upon further analysis. We are pleased that the development programme for daratumumab remains expansive and continues to benefit patients with Multiple Myeloma.”

Matt Fellows

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