Landmark CARTITUDE-4 study results show CARVYKTI® reduced the risk of death by 45 percent after three-year follow-up

Late-breaking data featured in an oral presentation at the 21st International Myeloma Society Annual Meeting SOMERSET, N.J., Sept. 27, 2024 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced late-breaking three-year follow-up data from the Phase 3 CARTITUDE-4 study that shows a single infusion of CARVYKTI® (ciltacabtagene autoleucel) significantly extended overall survival (OS) in patients with relapsed or lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor (PI), and an immunomodulatory agent (IMiD), reducing the risk of death by 45 percent versus standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).1 CARVYKTI® is now the first and only cell therapy to improve OS versus standard therapies for patients with lenalidomide-refractory multiple myeloma as early as second line.1 These results were presented as a late-breaking oral presentation at the 2024 International Myeloma Society (IMS) Annual Meeting (Abstract #OA-65) in Rio de Janeiro, Brazil.1

"These long-term results are groundbreaking and demonstrate that CARVYKTI significantly extends patients' overall survival and meaningly improves their quality of life,” said Maria-Victoria Mateos, M.D., Ph.D., Consultant Physician in the Hematology Department and Associate Professor of Medicine at the University of Salamanca, Spain. "These data show that with a single infusion, we can reduce the risk of death and offer multiple myeloma patients the opportunity to live longer.” ‡  

"These data underscore Legend's commitment to providing patients with effective treatments that have the potential to improve their quality of life and prolong survival,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. "We will continue to investigate the benefits CAR-T can bring to patients by investing significantly in R&D and exploring the full spectrum of CAR-T technologies.”

The Phase 3 CARTITUDE-4 study evaluated CARVYKTI® compared to standard therapies of PVd or DPd for the treatment of patients with relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy.1 Patients who received one to three prior lines of therapy, including a PI and IMiD, and were lenalidomide-refractory were randomized [cilta-cel, n=208, standard therapies, n=211].1 At median follow-up of almost three years (34 months), median OS was not reached [NR] for patients in the CARVYKTI® arm (95 percent Confidence Interval [CI], not estimable (NE) - NE) or patients that received standard therapies (95 percent CI, 37.75 months - NE) (Hazard Ratio [HR], 0.55; 95 percent CI, 0.39-0.79, P=0.0009).1 At 30-months follow up, OS rates were 76 percent for patients in the CARVYKTI® arm and 64 percent for patients treated with standard therapies.1 These data show CARVYKTI® significantly extended OS for patients compared to standard therapies.1

In patients randomized to the CARVYKTI® arm, CARVYKTI® reduced the risk of death by 45 percent compared to standard therapies demonstrating clinically meaningful responses for patients as early as after first relapse.1 Median progression-free survival (PFS) was NR in the CARVYKTI® arm (95 percent CI, 34.50 months - NE) and 11.79 months (95 percent CI, 9.66-14.00) in patients treated with standard therapies demonstrating sustained deep and durable responses.1 Patients in the CARVYKTI® arm had a 77 percent complete response or better, and 85 percent overall response rate.   Patients in the CARVYKTI® arm had 62 percent minimal residual disease (MRD)negativity at 10-5 and 57 percent MRD-negativity at 10-6, compared to patients treated with standard therapies (18.5 percent, 9 percent), respectively.1 Median duration of response was NR (95 percent CI, NE-NE) in the CARVYKTI® arm and 18.69 months (95 percent CI, 12.91-23.72) for patients treated with standard therapies.1 Median time to symptom worsening based on Multiple Myeloma Symptom and Impact Questionnaire (MySlm-Q) was NR (95 percent CI, NE-NE) with CARVYKTI® and 34.33 months (95 percent CI, 32.20-NE) with patients treated with standard therapies (HR, 0.38, 95 percent CI, 0.24-0.61; p