J&J, Legend say Carvykti beat standard therapy in earlier-line blood cancer
J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.
Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.
Legend shares went up briefly about 4% in pre-market trading Friday, but returned to even after the opening bell.
Carvykti is expected to be one of J&J’s top upcoming moneymakers, and the Big Pharma has carefully laid out plans to make it a bestseller. The first was getting it approved last February for relapsed or refractory MM patients who have received at least four previous therapies.
CARTITUDE-4 marked the next step in the strategy, moving Carvykti into earlier lines of the same patient population. The results were hotly anticipated ahead of J&J’s fourth-quarter results presented earlier this week, but didn’t end up making the cut. Cowen analysts did say, however, that Legend told them the study met its pre-specified endpoints.
Although there aren’t any numbers to pore over just yet, J&J said the study looked at PFS as the primary and safety, overall survival and overall response rate as secondary endpoints, among other data. Researchers pit Carvykti against pomalidomide, an immunotherapy; dexamethasone, a corticosteroid; and either bortezomib (targeted chemo) or Darzalex (monoclonal antibody).
Carvykti’s success Friday helps it pass a key test in its fight for market share with Abecma, as the two therapies are the sole anti-BCMA CAR-Ts on the market — and both are approved in late-line multiple myeloma. But Bristol Myers reached the market first, in March 2021, leaving Carvykti playing from behind.