Looking for Darzalex sales expansion, J&J, Genmab hit a wall in lymphoma

Darzalex
Darzalex netted $572 million in 2016 sales for J&J.

Johnson & Johnson’s blood cancer treatment Darzalex got a critical boost late last year when a jump into earlier lines of multiple myeloma treatment widened its sales potential. But now, the med and its megablockbuster ambitions have hit a snag.

Darzalex had been under study in non-Hodgkin’s lymphoma (NHL)—and a set of potential indications that could have helped take the med closer to the $9 billion-plus sales haul predicted by Jan van de Winkel, CEO at J&J partner Genmab.

But Denmark-based Genmab has now said it won't move Darzalex into the second stage of a phase 2 study examining the med as monotherapy in three types of relapsed or refractory NHL. The reason? A data review showing that two of the study’s cohorts hadn’t reached overall response rate benchmarks of 50% and 30%.Meanwhile, in the third cohort, ORR couldn’t be evaluated.

The decision dashed hopes that solo Darzalex “could potentially provide a new treatment option in NHL patients with a high unmet medical need,” van de Winkel said in a statement. A J&J spokesman added that "there will be potentially future programs to support Darzalex-based combination studies, in NHL patients, as investigator initiated studies."

Last year, Darzalex brought in $572 million in sales for J&J—a long way off from the more-than-$9 billion van de Winkel has said it can “definitely” pull in one day. Of course, it’s still early days for the med, which won FDA approval in late 2015, and until relatively recently, Darzalex had been playing from behind a number of other rivals approved around the same time.

But last November, regulators bumped it up from a fourth-line treatment to a second-line option, putting it on more equal footing with other myeloma contenders.

And Darzalex is still under the lens in a number of potential indications, both in multiple myeloma and elsewhere. Investigators are studying the med in NK/T-cell lymphoma and myelodysplastic syndrome, as well as in solid tumors, van de Winkel said.