J&J, Legend's Phase III Success Secures Carvykti for Earlier Multiple Myeloma Treatment

Johnson & Johnson and Legend Biotech recently shared interim results from the Phase III CARTITUDE-4 study, highlighting improved survival rates for multiple myeloma patients treated with their CAR-T therapy, Carvykti (ciltacabtagene autoleucel). The specifics from the second interim analysis were not disclosed, but the companies announced that Carvykti led to a "statistically significant and clinically meaningful improvement" in overall survival compared to standard treatments. The Phase III study also confirmed that Carvykti’s safety profile in this setting aligns with its approved label.

Jordan Schecter, the disease area leader of multiple myeloma at J&J Innovative Medicine, emphasized that these results make Carvykti the first cell therapy to significantly improve overall survival compared to the standard of care for multiple myeloma patients as early as the second line of treatment. J&J and Legend plan to present the CARTITUDE-4 findings at an upcoming medical conference and will relay the information to global regulatory authorities.

Carvykti is a genetically modified autologous T-cell immunotherapy targeting the BCMA protein, typically expressed by multiple myeloma cells. This mechanism enables Carvykti to direct T-cells to BCMA-positive cells, activating their anti-cancer properties. The CAR-T therapy received its initial FDA approval in February 2022 for treating patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy. In April 2024, the FDA broadened its label for use in patients who had undergone at least one prior treatment. This supplemental approval was supported by progression-free survival data from CARTITUDE-4, showing that Carvykti reduced the risk of disease progression or death by 74% compared to standard care. These findings were published in June 2023 in The New England Journal of Medicine.

Recently, CAR-T therapies, including Carvykti, have been under scrutiny by the FDA due to concerns about secondary malignancies in treated patients. In November 2023, the FDA initiated an investigation into these reports. By April 2024, the FDA mandated that manufacturers of CAR-T therapies include the risk of secondary cancers in their boxed warnings.

However, a recent Stanford study published in The New England Journal of Medicine indicated that the risk of secondary malignancies associated with CAR-T treatments is quite low. Out of 724 patients treated with CAR-T at Stanford Health Care from 2016 to 2024, only 6.5% developed secondary cancers over a median follow-up period of three years. One patient succumbed to a secondary malignancy, though Stanford researchers suggested this was more likely due to the immunosuppression linked to CAR-T treatments rather than an error in the gene insertion of the CAR construct.

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!