J&J's Darzalex slashes risk of myeloma progression by more than 60%

myeloma cells
Photo of multiple myeloma cells courtesy of Dr. Michael G. Bayerl, Hematopathology, Penn State Hershey Medical Center, via myelomapennstate.net.

CHICAGO—Johnson & Johnson's multiple myeloma med Darzalex won FDA approval last year amid a flurry of green lights for new rival meds. But now, some new trial data could help set Darzalex apart from the pack.

Darzalex--in tandem with standard-of-care med Velcade and dexamethasone--cut the risk of disease progression or death among previously treated myeloma patients by 61% compared with the standard combo alone, according to Phase III study results that rolled out Sunday at the American Society of Clinical Oncology annual meeting.

Adding Darzalex into the mix also upped the overall response rate among patients to 83% from 63%, J&J's Janssen unit said, and the product doubled the rate of complete response, taking it to 19% versus the 9% the Velcade/dexamethasone combo posted on its own.


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That’s good news for Darzalex as it sets out against a line-up of new myeloma competitors--as well as a few that have been around for awhile. Takeda’s Ninlaro and Bristol-Myers Squibb and AbbVie’s Empliciti also nabbed go-aheads from the FDA late last year, and the trio of newcomers joined meds like Amgen’s Kyprolis and Celgene’s Pomalyst in the myeloma arena.

Craig Tendler, Janssen VP of late-stage development and global medical affairs for oncology and hematology, for one, says the new data could give Darzalex an edge over some of those rivals.

“When we look at other add-ons that have recently been added to similar Velcade-based backbones, this one seems to be at a much higher impact than some of the other agents,” he told FiercePharma at the ASCO meeting. While there are caveats to comparing across different studies, he said, “all the studies had the same Velcade-based backbone, so the fact that we’re seeing such a magnitude of an effect with the addition of Darzalex suggests that that’s a very compelling and clinically meaningful combination."

Of course, that doesn’t mean the other myeloma newcomers will be left out in the cold. “Many of these patients will go through many of these regimens; the nature of this disease is multiple relapses,” Tendler said, adding, "The more options you have, especially in upfront and high-risk patients … the more likely we’ll be able to achieve the outcomes.”

- read the release

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J&J undercuts Celgene's Pomalyst with $135K-per-year Darzalex price
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