Johnson & Johnson has recently reported positive topline results from the Phase III MajesTEC-9 study evaluating Tecvayli monotherapy in patients with relapsed or refractory multiple myeloma. The investigational bispecific T-cell engager demonstrated a 71 percent reduction in the risk of disease progression or death and a 40 percent reduction in the risk of death compared with standard-of-care regimens.

The study population primarily consisted of patients refractory to commonly used therapies, including anti-CD38 monoclonal antibodies and lenalidomide groups with significant unmet treatment needs. Results showed superior Progression-Free Survival (PFS) and Overall Survival (OS) with Tecvayli as early as second-line treatment.

MajesTEC-9 evaluated the medication against standard regimens such as Pomalidomide, Bortezomib and dexamethasone (PVd), or carfilzomib and dexamethasone (Kd), in patients who had received one to three prior lines of therapy. More than 85 percent of enrolled patients were refractory to anti-CD38 therapies, while nearly 80 percent were refractory to lenalidomide.

According to investigators, the medication’s safety profile was clinically manageable and consistent with previous studies, with no new safety signals observed. Based on the strength of the interim data, the Independent Data Monitoring Committee recommended unblinding the study.