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CARVYKTI® ▼ (ciltacabtagene autoleucel; cilta-cel) is the first cell therapy to significantly extend overall survival versus standard therapies for patients with multiple myeloma as early as second line

October 1, 2024 – – Cell Therapy, Johnson & Johnson, clinical trials, multiple myeloma

45 percent reduction in risk of death achieved with cilta-cel versus standard therapies after threeyear follow-up in landmark CARTITUDE-4 study
Data featured in a late-breaking oral presentation at the 2024 International Myeloma Society Annual Meeting

27 September 2024 – Beerse, Belgium – (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). 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. 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)

“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. 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). 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)]. 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. These data show cilta-cel significantly extended OS for patients compared to standard therapies.

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. Median progression-free survival (PFS) was NR in patients treated with ciltacel (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. Patients treated with cilta-cel had a 77 percent complete response or better, and 85 percent overall response rate. 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. 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. Median time to symptom worsening based on the Multiple Myeloma Symptom and Impact Questionnaire (MySlm-Q) was NR (95 percent CI, NE-NE) with ciltacel 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<0.0001).

“This longer-term follow up data reinforces the potential of cilta-cel to redefine outcomes, delivering results that are unprecedented in this patient population from first relapse with multiple myeloma, including a first look at overall survival,” said Edmond Chan, MBChB, M.D. (Res), EMEA Therapeutic Area Lead Haematology, Innovative Medicine, Johnson & Johnson. “We are striving to transform outcomes for all patients and cilta-cel is testament to our focus on advancing innovative approaches that target multiple myeloma in different ways, at every stage of the disease.”

The safety profile of cilta-cel versus standard therapies was consistent with previous analysis. In the safety analysis (cilta-cel, n=208; standard therapies, n=208), 97 percent of patients in both arms experienced grade 3/4 treatment-emergent adverse events (TEAEs) with cytopenia being the most common. Treatment-emergent infections occurred in 64 percent of patients in the cilta-cel arm and 76 percent of patients who received standard therapies, with 28 percent and 30 percent being classified as grade 3/4, respectively. In the cilta-cel arm, there were seven patients with haematologic second primary malignancies, 50 patients died and of those patients, 21 died due to progressive disease. One patient treated with standard therapies experienced a haematologic second primary malignancy, 82 patients died and of those patients, 51 died due to progressive disease.

“Cilta-cel is the first cell therapy approved for the treatment of people living with myeloma as early as second line, and now also the first cell therapy to improve overall survival and demonstrate improved patient quality-of-life outcomes versus standard therapies for patients with lenalidomiderefractory multiple myeloma,” said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Innovative Medicine, Johnson & Johnson. “At Johnson & Johnson, we remain committed to addressing unmet need through the development of innovative treatments for patients and healthcare providers, and we look forward to submitting these results to local health authorities worldwide.”