On September 27, 2024, in New Jersey, the latest three-year follow-up data from Carvykti‘s Phase 3 CARTITUDE-4 study was released.
- Landmark results from the CARTITUDE-4 study demonstrate that Carvykti (cilta-cel) reduces the risk of death by 45% after three years of follow-up.
- The latest data was presented at the 21st International Myeloma Society Annual Meeting.
The results indicate that a single infusion of Carvykti significantly extends overall survival (OS) in patients with relapsed or lenalidomide-resistant multiple myeloma who have previously received at least one frontline therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD). Compared to standard therapies such as pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd), the risk of death was reduced by 45%. Carvykti is the first and only cell therapy to improve overall survival in second-line multiple myeloma patients who are resistant to lenalidomide. These findings were reported in a presentation at the 2024 International Myeloma Society (IMS) Annual Meeting in Rio de Janeiro, Brazil.
These long-term results are groundbreaking, demonstrating that CARVYKTI can significantly extend patients’ overall survival and improve their quality of life. These data show that through a single infusion, we can reduce the risk of death and provide multiple myeloma patients with a chance for prolonged life.
María-Victoria Mateos, MD, PhD
Associate Professor
University Hospital of Salamanca
Salamanca, Spain
These data underscore our commitment to providing effective treatments that improve quality of life and extend survival for patients. We will enhance our R&D investments and comprehensively explore CAR-T technology to continue studying the benefits it can bring to patients.
Dr. Ying Huang
CEO of Legend Biotech
The Phase 3 CARTITUDE-4 study evaluated the efficacy of Carvykti compared to standard therapies (PVd or DPd) in patients with relapsed or lenalidomide-resistant multiple myeloma who had received at least one frontline therapy. Patients with prior treatment (ranging from one to three lines, including PIs and IMiDs) were randomized (cilta-cel group, n=208; standard therapy group, n=211). During a median follow-up of nearly three years (34 months), the median OS for the Carvykti treatment group (95% CI, NE-NE) and the median OS for the standard therapy group (95% CI, 37.75 months-NE) were not reached (HR, 0.55; 95% CI, 0.39-0.79, P=0.0009). At the 30-month mark, the OS rate for the Carvykti treatment group was 76%, while the OS rate for the standard therapy group was 64%. These data indicate that CARVYKTI can significantly extend patients’ OS compared to standard therapy.
In the randomized Carvykti treatment group, the risk of death was reduced by 45% compared to standard therapy, showing clinically meaningful efficacy shortly after first relapse. The median progression-free survival (mPFS) for the Carvykti group (95% CI, 34.5 months-NE) was not reached, while the median PFS for the standard therapy group was 11.79 months (95% CI, 9.66-14.00), indicating deep and durable responses. The rate of complete response and above in the Carvykti treatment group was 77%, with an overall response rate of 85%. Additionally, 62% of patients in the Carvykti group achieved minimal residual disease (MRD) negativity at 10^-5, and 57% at 10^-6, compared to 18.5% and 9%, respectively, in the standard therapy group. The median duration of response in the Carvykti treatment group was not reached (95% CI, NE-NE), while it was 18.69 months (95% CI, 12.91-23.72) for the standard therapy group. According to the Myeloma Symptoms and Quality of Life questionnaire (MySlm-Q), the median time until symptom deterioration for the Carvykti treatment group was not reached (95% CI, NE-NE), compared to 34.33 months for the standard treatment group (HR, 0.38; 95% CI, 0.24-0.61; P<0.0001).
The safety profile of cilta-cel was consistent with previous results. In the safety analysis group (cilta-cel, n=208; standard therapy, n=208), 97% of patients in both groups experienced treatment-emergent adverse events (TEAEs) of grade 3/4, with the most common being cytopenias. In the Carvykti treatment group, 63% of patients and 76% of standard therapy patients experienced infections post-treatment, with 28% and 30% classified as grade 3/4, respectively. In the Carvykti treatment group, seven patients developed secondary primary malignancies in the blood system, and 50 patients died, with 21 deaths attributed to disease progression. In the standard therapy group, one patient developed a secondary primary malignancy in the blood system, and 82 patients died, with 51 deaths due to disease progression.
Data from CARTITUDE-4 supports the earlier approvals of Carvykti by the FDA and the European Commission for treating adult patients with relapsed or refractory multiple myeloma who have received at least one line of therapy, including one PI and IMiD, and are resistant to lenalidomide. To date, Carvykti has been launched in five countries, treating over 3,500 patients globally.
