J&J, Genmab Unveil Darzalex Faspro Data with Eye Toward Earlier Multiple Myeloma Lines


Johnson & Johnson/iStock, JHVEPhoto

Pictured: Johnson & Johnson Sign/iStock, JHVEPhoto

Johnson & Johnson and Genmab’s first data from the Phase III Perseus study showed clinical improvement in patients with transplant-eligible newly diagnosed multiple myeloma treated with a Darzalex Faspro-based quadruplet therapy regimen, according to a late-breaking oral presentation at the American Society of Hematology annual meeting on Tuesday.

The data displayed favorable progression-free survival in for a combination treatment of Darzalex (daratumumab and hyaluronidase-fihj) with bortezomib, lenalidomide and dexamethasone, followed by the anti-CD38 antibody. The combo also demonstrated improvement in the complete response rate and “better and minimal” residual disease negativity over the comparator arm.

Results from the study, also published on Tuesday in The New England Journal of Medicine, showed that the four-drug combo reduced the risk of disease progression or death by 58% versus bortezomib, lenalidomide and dexamethasone on its own earning a p-value of p<0.0001.

The Darzalex combination also recorded “deeper responses” against the trio, which included higher complete response rates—69.3% complete response rates for the Darzalex combo versus 44.6% for the other. This earned a p-value of p<0.0001. Minimal residual disease negativity rates were higher in the Darzalex combo at 75.2% versus 47.5% for the other combo, netting a p-value of p<0.0001. For sustained minimal residual disease negativity rates, J&J said that it was more than double in the Darzalex arm, at 64.8% compared to 29.7%, also getting a p-value of p<0.0001.

The data for overall survival has not come in yet. However, J&J said the Darzalex arm is “trending favorably.”  

“We now have evidence supporting this Darzalex-based quadruplet induction and consolidation regimen and doublet maintenance regimen as a potential new standard of care in transplant-eligible disease, complementing data from the Phase 3 MAIA study, which firmly established a Darzalex-based triplet therapy as standard of care in transplant-ineligible disease,” Craig Tendler, vice president of late development and global medical affairs at J&J Innovative Medicine said in a statement.

The safety of the quartet has been consistent with known safety profiles, with the most common adverse events including neutropenia, thrombocytopenia, diarrhea, pneumonia and febrile neutropenia. 

“The results we see across clinically relevant subgroups, including in patients who present with advanced disease or who are considered high risk, are promising for clinicians who are on the frontlines of treating patients who are newly diagnosed with this complex disease,” Pieter Sonneveld a professor of Hematology at the Erasmus University of Rotterdam and chair of the Erasmus MC Cancer Institute in Rotterdam, Netherlands, said in a statement. 

Darzalex Faspro was approved by the FDA in May 2020 and is okayed for eight indications in multiple myeloma, three of which are for the frontline. The drug is also a significant moneymaker for J&J, pulling in over $2.4 billion in global sales in the third quarter of 2023. 

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

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