Johnson & Johnson (JNJ), on Tuesday, announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval for an indication extension of TECVAYLI (Teclistamab) as monotherapy for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy.
Teclistamab is an off-the-shelf bispecific antibody that, when administered subcutaneously, redirects T-cells to two cellular targets, BCMA and CD3, to activate the body's immune system and fight cancer. Teclistamab is currently being evaluated in several combination studies.
The submission is bolstered by data from the Phase 3 MajesTEC-9 trial evaluating the efficacy and safety of Teclistamab versus the standard of care of Pomalidomide, Bortezomib, and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd) in 614 patients with RRMM who have received 1-3 prior lines of therapy, including an anti-CD38 monoclonal antibody and Lenalidomide.
The primary endpoints of Phase 3 MajesTEC-9 trial are progression-free survival (PFS) and the number of participants reporting cytokine release syndrome (CRS) cases by severity.
Results showed that Teclistamab delivers superior progression-free survival (PFS) and overall survival (OS) compared with standard of care as early as in second-line.
These results include a 71% reduction in the risk of disease progression or death with hazard ratio (HR,0.29; 95% confidence interval [CI], 0.23-0.38) and a 40% reduction in the risk of death (HR, 0.60; 95% CI, 0.43-0.83) in a patient population that was predominantly refractory to anti-CD38 monoclonal antibodies and lenalidomide.
Secondary endpoints include complete response or better, duration of response (DOR), time to next treatment (TTNT), progression-free survival on next-line therapy (PFS2), overall survival (OS), and the number of participants with adverse events (AEs) and serious adverse events (SAEs) by severity.
In addition, secondary endpoints include changes from baseline in symptoms, functioning, and overall health-related quality of life (HRQoL), as assessed by the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30); and time to worsening in symptoms, functioning, and overall HRQoL.
According to the firm, the safety profile of Teclistamab monotherapy was clinically manageable and consistent with its known profile, with no new safety signals identified.
Following that, the Independent Data Monitoring Committee recommended unblinding the study based on the strength of the data in the first pre-specified interim analysis. The full results are to be presented at a major medical meeting in the future.
In multiple myeloma, though there are advanced treatments including anti-CD38-based quadruplet regimens, most patients will ultimately relapse, and outcomes are particularly poor once patients become refractory to key backbone therapies such as anti-CD38 monoclonal antibodies and lenalidomide, as stated by the firm.
Notably, in August 2022, Teclistamab received European Commission (EC) approval for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.
In August 2023, the EC approved a Type II variation application for Teclistamab, providing the option of a reduced dosing frequency of 1.5mg/kg every 2 weeks in patients who have achieved a complete response (CR) or better for at least 6 months.
JNJ has traded between $141.50 and $251.71 in the prior year. The stock closed Monday's trading at $242.59, up 0.91%.
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