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The study population consists of patients who received 1-3 prior lines of therapy for relapsed and lenalidomide-refractory multiple myeloma.
Data from the phase 3 CARTITUDE-4 interim analysis showed the primary endpoint of progression-free survival (PFS) in adult patients with relapsed and lenalidomide-refractory multiple myeloma was achieved, according to today's announcement.
The international, randomized, open-label clinical trial included patients that had previously received 1-3 lines of therapy. Patients treated with ciltacabtagene autoleucel; cilta-cel (Carvykti) exhibited significant improvement in progression-free survival when compared with patients treated with pomalidomide, bortezomib, and dexamethasone (PVd), or daratumumab, pomalidomide, and dexamethasone (DPd).
"The CARTITUDE-4 study represents the first phase 3 program in our comprehensive clinical development strategy for CARVYKTI, and further demonstrates our commitment to advance the treatment of patients with relapsed/refractory multiple myeloma," Jordan Schecter, MD, Vice President, Clinical Development Cellular Therapy Program, Janssen Research & Development, said in a statement. "We look forward to the presentation of the data from the CARTITUDE-4 study at a future medical meeting."
Cilta-cel was granted approval by the FDA in February 2022 for the treatment of adults with relapsed or refractory multiple myeloma that had at least 4 prior lines of therapy: a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
“Autologous CAR-T cell therapy represents a major breakthrough in cancer treatment, and topline results from CARTITUDE-4 support our continuous efforts to bring this treatment option to patients with multiple myeloma in various stages of disease progression," Lida Pacaud, Vice President of Clinical Development and Medical Affairs, Legend Biotech, stated.