J&J and Legend share long-term Carvykti results in phase 3 multiple myeloma study

Johnson & Johnson (J&J) and Legend Biotech have announced encouraging long-term results for their BCMA-directed T-cell immunotherapy, Carvykti (ciltacabtagene autoleucel), aimed at treating multiple myeloma in patients who have previously undergone treatment.

The phase 3 CARTITUDE-4 study has been investigating Carvykti against two other treatment regimens: pomalidomide, bortezomib, and dexamethasone (PVd); and daratumumab, pomalidomide, and dexamethasone (DPd). The study targets adults with relapsed and lenalidomide-refractory multiple myeloma who have been treated with one to three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD).

In 2024, it is projected that over 35,000 new cases of multiple myeloma, a type of blood cancer affecting plasma cells, will be diagnosed in the United States. Carvykti is developed using a patient’s own T-cells. These cells are extracted from the patient's blood, genetically modified, and then reintroduced to the patient through a single intravenous infusion.

The results, shared at this year’s International Myeloma Society Annual Meeting, demonstrate that Carvykti reduces the risk of death by 45% compared to standard therapies after nearly three years of follow-up. The median overall survival (OS) was not reached in either group, but at the 30-month mark, OS rates were 76% for patients treated with Carvykti, compared to 64% for those on PVd or DPd regimens.

Carvykti is now the first cell therapy to show improved overall survival compared to standard treatments for patients with lenalidomide-refractory multiple myeloma as early as the second line of treatment. The therapy has already received approvals for treating certain adults with previously-treated multiple myeloma. Most recently, it was approved by the European Commission for the treatment of relapsed and refractory multiple myeloma in patients who have received at least one prior therapy, including an IMiD and a PI, shown disease progression on their last therapy, and are refractory to lenalidomide.

Binod Dhakal, an investigator from the Medical College of Wisconsin, commented on the significance of the findings: "The three-year follow-up data from the phase 3 CARTITUDE-4 study shows a statistically significant and clinically meaningful improvement in OS and quality-of-life measures with Carvykti versus standard therapies – results that have the potential to transform the multiple myeloma treatment landscape. This adds to the growing body of data reinforcing the promise of a single infusion of Carvykti, which not only demonstrates a significant OS benefit but also offers patients the opportunity for a period free from multiple myeloma treatment as early as the second line."

In summary, the positive long-term results from the CARTITUDE-4 study highlight the potential of Carvykti to significantly improve survival rates and quality of life for patients with lenalidomide-refractory multiple myeloma, potentially changing the standard approach to treatment for this challenging condition.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!