Johnson & Johnson and partner Legend biotech said Friday that their cancer cell therapy showed early signs of success in a key clinical trial.
The trial compares Carvykti, as the therapy is called, against two standard treatment regimens for advanced multiple myeloma. According to its developers, a preplanned interim analysis found Carvykti met the study’s main objective, as patients on it are living significantly longer without their cancer getting worse.
J&J and Legend didn’t report any specific data from the analysis, but said results will be presented at an upcoming scientific congress and shared with regulators in planned approval applications. The study will continue to follow participants to track other measures like overall survival.
In the U.S., Carvykti is already cleared for use in multiple myeloma patients whose cancer progressed or returned after at least four other kinds of therapies. But J&J and Legend want to broaden the drug’s use by showing it can be effective earlier on in the treatment process.
The positive interim analysis is a crucial step toward that goal. Notably, the trial, named CARTITUDE-4, only enrolled patients who had previously received between one and three other therapies. It’s also the first randomized Phase 3 study of Carvykti, which won approval based on an earlier open-label trial.
Another study, CARTITUDE-5, is evaluating Carvykti after a three-drug regimen in patients with newly diagnosed multiple myeloma who aren’t getting a stem cell transplant as initial treatment. Data from that study are expected in 2026.
Securing approval in earlier lines should help lift sales of Carvykti, which totaled $55 million in both the third and fourth quarters of last year. On an earnings call this week, J&J CEO Joaquin Duato said the CARTITUDE-4 results will be “very important” to the company’s ambitions in multiple myeloma.
Duato said, too, that J&J’s portfolio of multiple myeloma drugs is “the most important growth driver for our pharmaceutical [division] moving forward.” Aside from Carvykti, the portfolio includes Darzalex, the new-to-market Tecvayli, and an experimental medicine called talquetamab that was submitted to the Food and Drug Administration for approval last month.
Unlike those other drugs, Carvykti is what’s known as a CAR-T cell therapy. These personalized treatments have proven to be powerful new weapons, eradicating malignant cells in certain hard-to-treat blood cancers. They’re made by harvesting immune cells from the patient in question, engineering them in a lab to better fight cancer, and then reinfusing them.
Duato noted on J&J’s earnings call that demand for Carvykti has been “very strong,” and that the company is working to build up production capacity and expand its provider network.