NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) announced positive topline results from the investigational Phase 3 MajesTEC-9 study of TECVAYLI (teclistamab-cqyv) monotherapy. The study demonstrated that TECVAYLI reduced the risk of disease progression or death by 71% and the risk of death by 40% in patients with multiple myeloma who were predominantly refractory to anti-CD38 therapy and lenalidomide.
The data confirm that TECVAYLI provides superior progression-free survival (PFS) and overall survival (OS) compared to standard of care as early as second line treatment. Importantly, this marks the second positive Phase 3 study supporting TECVAYLI regimens as a potential new standard of care for patients experiencing their first relapse.
These findings highlight TECVAYLI's potential to address a high unmet medical need in multiple myeloma, offering improved outcomes for patients with limited treatment options.
TECVAYLI received accelerated approval from the U.S. Food and Drug Administration (FDA) in October 2022 as an off-the-shelf (or ready-to-use) antibody that is administered as a subcutaneous treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
In February 2024, the U.S. FDA approved the supplemental Biologics License Application (sBLA) for TECVAYLI for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients with RRMM who achieved and maintained a complete response (CR) or better for a minimum of six months.
The European Commission granted TECVAYLI conditional marketing authorization in August 2022 as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy.
In August 2023, the EC approved a Type II variation application for TECVAYLI, providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients who have achieved a complete response or better for a minimum of six months.
JNJ closed Wednesday's regular trading session at $218.55, up $4.90 or 2.29%. In overnight trading at 10:14 PM EST, the stock was trading at $218.06, down $0.49 or 0.22%.
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