CARVYKTI® Outshines Standard Care In Achieving MRD Negativity For Relapsed Multiple Myeloma Patients

Legend Biotech shared new Phase 3 CARTITUDE-4 study results showing that a single dose of CARVYKTI® (cilta-cel) significantly improved MRD negativity rates in patients with relapsed or lenalidomide-refractory multiple myeloma. These patients had previously received at least one line of therapy, including a proteasome inhibitor and an immunomodulatory agent. Compared to standard treatments like PVd or DPd, CARVYKTI® demonstrated better outcomes, reinforcing its potential as a second-line treatment and its impact on overall survival. The findings were presented at the 66th ASH Annual Meeting in San Diego.

Yi Lin, M.D., Ph.D., hematologist and oncologist at Mayo Clinic, Rochester, MN, said in a statement, “The MRD data further underscores the benefits of treatment with CARVYKTI. These new findings support CARVYKTI as a transformative therapeutic option, leading to improved progression-free survival, overall survival, and now minimal residual disease negativity.” 

The Phase 3 CARTITUDE-4 study compared CARVYKTI® to standard therapies (PVd or DPd) in adults with relapsed or refractory multiple myeloma who had received 1–3 prior treatments, including a PI and IMiD, and were lenalidomide-refractory. Among 208 patients treated with CARVYKTI® and 211 with standard therapies, CARVYKTI® achieved a significantly higher MRD-negativity rate (89% vs. 38%) at nearly three years of follow-up. Additionally, 69% of patients receiving CARVYKTI® reached MRD negativity by day 56, and 52% sustained it for 12+ months compared to 10% on standard therapies. Results suggest CARVYKTI® works better when used earlier in treatment.

Ying Huang, Ph. D., Chief Executive Officer of Legend Biotech, also stated, “The latest MRD data showcases the advances of CARVYKTI and further demonstrates why it is a leading treatment for patients with multiple myeloma. As we strive to transform the therapeutic landscape in cancer and beyond, we are proud of the progress made and will continue our efforts to improve the quality of life for those battling incurable diseases.”

CARTITUDE-4 data led to the FDA and European Commission approvals of CARVYKTI® earlier this year for adults with relapsed or refractory multiple myeloma who have had at least one prior treatment, including a PI and IMiD, and are refractory to lenalidomide. CARVYKTI® is the first BCMA-targeted CAR-T cell therapy approved for this patient group. It is now available in five countries worldwide and has been used by over 4,500 patients.