ASCO: J&J eyes Darzalex convenience, safety boost with subcutaneous win

CHICAGO—Right now, the first infusion of Johnson & Johnson multiple myeloma fighter Darzalex can take between seven and eight hours. But data on a new formulation could be a game changer.

At the American Society of Clinical Oncology annual meeting, the New Jersey drugmaker trumpeted results from a phase 3 study showing that a subcutaneous form of Darzalex could measure up to the original—and with an average injection time of just five minutes.

At a median 7.5 months of follow-up, 41% of patients in the head-to-head study—which enrolled relapsed or refractory patients—had seen benefits after receiving the subcutaneous drug, while 37% of those taking the infused drug could say the same.

And without skimping on efficacy, subcutaneous Darzalex recorded a big win, too. Only 12.7% of patients receiving the subcutaneous drug experienced infusion-related side effects—a big drop from the 34.5% of patients in the control group who reported them.

Those who did have reactions experienced just “mild to moderate” problems, said Craig Tendler, J&J’s VP of oncology clinical development and global medical affairs.

“There’s no compromise on efficacy, and we’re able to give a more convenient but also more tolerable regimen, and that becomes important for elderly populations in myeloma,” he added.

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Majorly cutting down on the time it takes to administer Darzalex could help not just patients, but healthcare providers, too, Tendler said. There are “a lot of nursing staff and personnel that are watching the patient closely with the first infusion,” he said. And if that first dose can wrap up in three to five minutes, “you could free up resources in the office for other things.”

As Credit Suisse analyst Vamil Divan pointed out in a note to clients, though, post-administration reactions took longer to show up in subcutaneous patients, with average onset times of 3.6 hours versus 1.5 hours—meaning additional monitoring may still be required. “The [new formula] should help address the prolonged infusion time that is needed for the IV formulation, although it was noted in the discussion that for the first subcutaneous dose an observation time of about 3-4 hours may still be needed,” he wrote.

Darzalex has already shaken up the multiple myeloma landscape in a major way over the past few years. Since winning its first approval in late 2015—a busy time for the field that also featured first approvals for Takeda’s Ninlaro and Bristol-Myers Squibb and AbbVie’s Empliciti – the drug has leapfrogged its way into previously untreated patients to dramatically expand its sales opportunities and enter blockbuster territory.

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And while the field is only getting more crowded, with Sanofi’s candidate isatuximab posting what Divan called “strong pivotal data” over the weekend, analysts still see big things ahead for the J&J player.  

“While the competition in this area will continue to grow, we see Darzalex well positioned to continue growing as it moves into earlier lines of therapy and potentially into” smoldering myeloma in the future,” Divan wrote.