ASH: Johnson & Johnson scores big Darzalex win in first-line myeloma, slashing risks in half

Johnson & Johnson's Darzalex won a second-line go-ahead from the FDA in November.

ATLANTA—Johnson & Johnson’s Janssen unit has found plenty of success moving Darzalex earlier and earlier into multiple myeloma therapy, and it now has data that could help it win a coveted spot in first-line treatment.

On Tuesday at the American Society of Hematology (ASH) annual meeting, the company unveiled results from a trial showing that at a median follow-up of 16.5 months, Darzalex, in combination with Takeda's Velcade, melphalan and prednisone, cut the risk of disease progression or death by 50% in newly diagnosed myeloma patients.

Slicing that risk in half wasn't “something that five years ago you’d expect,” but the result is right in line with what J&J's Janssen unit predicted based on Darzalex’s prior performances. “The drug has been really active, and once we started seeing those results in the relapsed setting, we were expecting to see those results in earlier settings,” Peter Lebowitz, Janssen’s global therapeutic area head of oncology, said in an interview.

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The way the company sees it, this is only the beginning of the drug’s journey into first-line use. “What we’ve seen is that the drug seems to benefit with any regimens—with other IMiD-containing regimens, with proteasome regimens ... so our general view is that this is a mechanism that can improve on [results from] any established regimen,” Lebowitz said.

Janssen has a slew of other front-line studies ongoing in combination with other agents, including one that puts an IMiD, a proteasome inhibitor and Darzalex together into one cocktail. “We want it to be fairly universal that you use the drug with whatever regimen you end up choosing,” he said.

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While Darzalex started playing from behind—it won its first FDA approval, a nod in patients who had received three prior treatments, the same month AbbVie and Bristol-Myers Squibb’s Empliciti and Takeda’s Ninlaro picked up approvals for use earlier in treatment—it’s been quick to catch up to its rivals. Last November, it snagged a go-ahead in second-line use.

And Janssen isn’t planning on stopping at first-line treatment. It's pushing even earlier. Also at ASH, the company touted phase 2 results for Darzalex in smoldering multiple myeloma, a precursor to multiple myeloma that puts patients at risk of developing more serious disease.

“Earlier stages of disease are less complex—less able to evade treatment mechanisms and develop resistance—and so we want to begin intervening earlier in those settings,” Lebowitz said, calling the study’s response rates “very impressive.”

“That sort of sets the paradigm beyond just front-line and going into even earlier settings,” he added.