ORLANDO, FLORIDA—Johnson & Johnson hasn’t had problems convincing doctors to use multiple myeloma med Darzalex, which quickly shot to blockbuster status and beyond on the back of some historic approvals. But new "gold standard" data presented Monday could further increase doctors’ confidence in the med, the company says.
In a phase 3 study of previously untreated myeloma patients not eligible for stem cell transplants, adding Darzalex (daratumumab) to a combination of melphalan, prednisone and Takeda’s Velcade cut the risk of death by 40%, J&J’s Janssen unit said at the American Society of Hematology annual meeting.
At the 42-month mark of the trial—dubbed Alcyone—75% of Darzalex patients were still alive, versus 62% of those receiving the regimen without the J&J drug.
Adding Darzalex also helped keep patients’ disease from worsening; the Darzalex-containing cocktail kept disease at bay for 36.4 months, as opposed to the 19.3 months for the melphalan- prednisone-Velcade trio.
“In many ways, the Alcyone data are a watershed moment,” Mark Wildgust, Janssen’s VP of global medical affairs for oncology, said. “We’ve now demonstrated that when using daratumumab, we see a survival benefit. That’s been something that I think the medical community’s been waiting for.”
That, of course, doesn’t mean physicians haven’t been prescribing Darzalex in the meantime. The drug bears two FDA green lights for newly diagnosed patients, and those helped the product’s sales climb to $2.17 billion through the first 9 months of 2019.
Still, “overall survival is the gold standard we want to see to confirm that when you start with your best agent first, you actually get the best result,” Wildgust said.
Meanwhile, thanks to Darzalex’s performance in Alcyone—the most mature trial it has in the front-line setting—the company has reason to believe it can put up similar results in other trials involving newly diagnosed patients.
The Maia study, for example—which helped J&J snag a Darzalex OK back in June alongside Celgene’s Revlimid and dexamethasone in transplant-ineligible patients—has already shown, as Alcyone did, a significant progression-free survival benefit and a benefit in PFS2, an endpoint that demonstrates how long a treatment can stave off disease after second-line therapy.
It “kind of points that the longer we wait, and as it becomes more mature, we’re likely to see survival in those studies, too,” Wildgust said.
J&J, for its part, certainly hopes so. “The real opportunity to potentially improve outcomes for patients” lies in treating “those newly diagnosed patients,” Wildgust said.