New model-based analysis further supports the potential of TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) to redefine long-term survival expectations in early line relapsed/refractory multiple myeloma

Analysis shows ~87% of patients treated with TECVAYLI ® plus DARZALEX FASPRO ® as early as second line were estimated to have comparable mortality risk to the general population A separate analysis shows the survival benefit was driven by a 90% reduction in the risk of multiple myeloma progression versus standard of care, with no significant difference in rates of non-relapse mortality Johnson & Johnson is advancing a differentiated multiple myeloma portfolio designed to deliver deeper, more durable disease control and improve long-term outcomes for patients RARITAN, N.J. , Sept. 23, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ ), a worldwide leader in multiple myeloma therapies, today announced new data from the Phase 3 MajesTEC-3 study showing sustained disease control and survival with TECVAYLI ® (teclistamab-cqyv) plus DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) in patients with relapsed or refractory multiple myeloma (RRMM) who had received 1-3 prior lines of therapy. Using a relative survival mixture cure model (MCM) and actual progression-free survival (PFS) and overall survival (OS) data from the trial, statistical modeling estimated that ~87% of patients treated with TECVAYLI ® plus DARZALEX FASPRO ® (Tec-Dara) may experience a mortality risk and projected life expectancy similar to an age-matched general population. Modeling further predicted that median overall survival with Tec-Dara would be nearly four-fold longer than with the standard of care (SOC) comparator in the study, dexamethasone with pomalidomide or bortezomib (DPd/DVd). These data help to illustrate to what extent treatment with TECVAYLI ® plus DARZALEX FASPRO ® as early as second line may reshape survival expectations in multiple myeloma. In the MajesTEC-3 study, TECVAYLI ® plus DARZALEX FASPRO ® significantly improved overall survival versus standard of care (SOC), with an estimated 83% of patients alive at 3 years. A post hoc analysis showed that Tec-Dara reduced the risk of cumulative incidence of disease progression by 90% versus SOC, with no significant difference in non-relapse mortality over time between the treatment arms. These data (Abstract #OA-58 and Abstract #OA-49) will be presented in two oral sessions at the International Myeloma Society (IMS) Annual Meeting. Expert and company perspectives emphasize the potential for durable, long-term disease control "These findings underscore how consequential treatment choice at first relapse can be in shaping a patient's long-term trajectory," said Dr. Luciano J. Costa, Professor of Multiple Myeloma and Director of the Multiple Myeloma Research and Treatment Program at the University of Alabama at Birmingham.* "The sustained disease control observed with TECVAYLI plus DARZALEX FASPRO is changing expectations for what treatment can achieve in relapsed or refractory multiple myeloma, moving beyond just delaying the next relapse toward the possibility of durable long-term disease control." "The continued analyses of the unprecedented MajesTEC-3 trial challenge long-held expectations of what may be possible in multiple myeloma," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. "Our ambition is to build on this progress by fundamentally changing the long-term trajectory of multiple myeloma and, ultimately, creating a future in which this disease is no longer defined as incurable." Model-based analysis projects potential long-term survival outcomes The MajesTEC-3 study evaluated TECVAYLI ® plus DARZALEX FASPRO ® versus investigator's choice of daratumumab SC plus DPd/DVd in patients with RRMM who had received one to three prior lines of therapy. In this analysis, a relative survival mixture cure model was applied to patients treated with TECVAYLI ® plus DARZALEX FASPRO ® (n=291) and DPd/DVd (n=296) to assess whether long-term disease control could translate into outcomes approaching those of the general ...