45 percent reduction in risk of death achieved with cilta-cel versus standard therapies after three-year follow-up in landmark CARTITUDE-4 study1

Data featured in a late-breaking oral presentation at the 2024 International Myeloma Society Annual Meeting1

BEERSE, BELGIUM , Sept. 27, 2024 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, announced today long-term results from the Phase 3 CARTITUDE-4 study that show a single infusion of CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) 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). Cilta-cel reduced the risk of death by 45 percent versus standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).1 With these data, cilta-cel is now the first cell therapy to improve OS versus standard therapies for patients with lenalidomide-refractory multiple myeloma as early as second line.1 Findings were featured as a late-breaking oral presentation at the 2024 International Myeloma Society (IMS) Annual Meeting, taking place in Rio de Janeiro, Brazil, from 25-28 September (Abstract #OA-65).1

"The three-year follow-up data from the Phase 3 CARTITUDE-4 study show a statistically significant and clinically meaningful improvement in overall survival and quality-of-life measures with cilta-cel versus standard therapies--meaningful results that have the potential to transform the multiple myeloma treatment landscape,” said Binod Dhakal, M.D., M.S., Associate Professor of Medicine at the Medical College of Wisconsin, Division of Hematology, and study investigator.* "This adds to the growing body of data reinforcing the promise of a single infusion of cilta-cel, which, in addition to demonstrating a significant overall survival benefit, also offers patients the opportunity of a period free from multiple myeloma treatment as early as second line.”

The Phase 3 CARTITUDE-4 study evaluated cilta-cel 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 immunomodulatory agent (IMiD), and were lenalidomide-refractory were randomised (cilta-cel, n=208; standard therapies, n=211).1 At median follow-up of almost three years (34 months), median OS for patients treated with both cilta-cel or standard therapies was not reached [NR] [(95 percent Confidence Interval [CI], not estimable (NE)-NE) and (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-month follow-up, OS rates were 76 percent for patients on the cilta-cel arm and 64 percent for patients on the standard therapies arm.1 These data show cilta-cel significantly extended OS for patients compared to standard therapies.1

In patients randomised to the cilta-cel arm, cilta-cel 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 patients treated with cilta-cel (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.2 Patients treated with cilta-cel had a 77 percent complete response or better, and 85 percent overall response rate.2 Patients treated with cilta-cel demonstrated a 62 percent minimal residual disease (MRD) negativity (10-5) and 57 percent MRD-negativity (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 patients treated with cilta-cel and 18.69 months (95 percent CI, 12.91-23.72) for patients treated with standard therapies.2 Median time to symptom worsening based on the Multiple Myeloma Symptom and Impact Questionnaire (MySlm-Q) was NR (95 percent CI, NE-NE) with cilta-cel 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