J&J and Legend report positive late-stage Carvykti results in multiple myeloma

Johnson & Johnson (J&J) and Legend Biotech have announced promising outcomes from their phase 3 study of Carvykti (ciltacabtagene autoleucel), a BCMA-directed T-cell immunotherapy, in patients with previously-treated multiple myeloma. This late-stage trial, known as CARTITUDE-4, evaluated Carvykti against two standard regimens: pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd). The study involved adults with relapsed and lenalidomide-refractory multiple myeloma who had undergone one to three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD).

Interim analysis of the trial data revealed a statistically significant and clinically meaningful enhancement in overall survival (OS) for patients treated with Carvykti compared to those on the standard regimens. Additionally, the safety profile of Carvykti was found to be consistent with its approved label. Jordan Schecter, vice president and multiple myeloma disease area leader at J&J Innovative Medicine, highlighted that Carvykti is now the first cell therapy to significantly improve OS against standard care for myeloma patients as early as the second line of treatment.

In the United States, over 35,000 new cases of multiple myeloma, an incurable blood cancer affecting plasma cells, are expected to be diagnosed in 2024. Carvykti uses a patient’s own T-cells, which are extracted from the blood, genetically modified, and reintroduced into the patient through a single infusion.

Carvykti is already approved for treating certain adults with previously-treated multiple myeloma. Most recently, the European Commission approved it for patients with relapsed and refractory multiple myeloma who have received at least one prior therapy, including an IMiD and a PI, who have shown disease progression on the last therapy, and are refractory to lenalidomide.

Ying Huang, CEO of Legend Biotech, expressed satisfaction with the observed OS benefit from a one-time infusion of Carvykti in the latest CARTITUDE-4 analysis. Huang emphasized that this data reinforces the significant benefits Carvykti offers to multiple myeloma patients combating an incurable disease.

The companies plan to present a detailed analysis of the trial at an upcoming medical meeting and submit the findings to regulatory authorities worldwide.