ASCO23: Results confirm benefit of earlier Carvykti use in myeloma

05 Jun 2023
firstwordpharma.com
Clinical ResultPhase 3Drug ApprovalASCO
Results presented Monday at the American Society of Clinical Oncology (ASCO) annual meeting confirmed those accidently leaked in April from the Phase III CARTITUDE-4 study of Johnson & Johnson and Legend Biotech's BCMA-directed CAR-T therapy Carvykti (ciltacabtagene autoleucel) in patients with multiple myeloma. The findings, inadvertently published by the European Hematology Association (EHA), had previously been authenticated by Legend.
The data showed that Carvykti reduced the risk of progression or death by 74% versus standard therapy, with median progression-free survival (PFS) of 12 months in the standard-care group, while it has not yet been reached in the CAR-T therapy arm, but has climbed above 23 months. Those results represent a cut-off of November 1 last year and median follow-up of 16 months.
Carvykti is currently approved in the US and EU for use in the fifth- and fourth-line settings, respectively, with results from CARTITUDE-4 seen as key to gaining clearance in earlier lines of treatment. The trial included 419 adults with relapsed and lenalidomide-refractory multiple myeloma who had already tried and failed one to three prior lines of therapy. Subjects were randomised to receive Carvykti or a regimen consisting of pomalidomide and dexamethasone plus either Johnson & Johnson's Darzalex (daratumumab) or Takeda's Velcade (bortezomib).
Binod Dhakal, lead author on CARTITUDE-4, said the findings show that Carvykti "is highly effective in patients with lenalidomide-refractory multiple myeloma as early as after first relapse."
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