Carvykti regimen extends PFS in advanced multiple myeloma
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A phase 3 trial of ciltacabtagene autoleucel for adults with relapsed or refractory multiple myeloma met its primary endpoint, according to the agent’s manufacturer.
Ciltacabtagene autoleucel (Carvykti; Janssen, Legend Biotech) — often called cilta-cel — is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell therapy.
The FDA approved the agent last year for treatment of patients who received four or more previous lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
The randomized CARTITUDE-4 study is evaluating the safety and efficacy of cilta-cel vs. pomalidomide, bortezomib and dexamethasone, or daratumumab (Darzalex, Janssen), pomalidomide and dexamethasone for adults with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.
The trial met its primary endpoint, with results of the first prespecified interim analysis showing significant improvement in PFS with the experimental regimen.
Based on the results, an independent data monitoring committee overseeing the CARTITUDE-4 trial recommended unblinding of the study.
“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, MD, vice president of clinical development and medical affairs at Legend Biotech, said in a company-issued press release.
Complete results from the study will be presented at a medical meeting and will support forthcoming regulatory submissions, according to the release.