Tecvayli plus Darzalex led to an 83% boost to progression-free survival versus the current standard therapy in relapsed or refractory multiple myeloma, results analysts at Guggenheim Securities called “remarkable.”
A combination of Johnson & Johnson’s bispecific Tecvayli and the anti-CD38 antibody Darzalex significantly lowered the risk of disease progression or death in a Phase III study of relapsed or refractory multiple myeloma, potentially setting the regimen up as a new standard of care in previously treated patients.
Guggenheim Securities in a note Monday evening called J&J’s data “exceptional” and “overwhelmingly positive,” adding that the drug demonstrated “clinically remarkable and statistically significant benefits.”
In the Phase III MajesTEC-3 study, J&J enrolled nearly 590 patients with relapsed or refractory multiple myeloma (RRMM) who had undergone one to three previous lines of therapy but still had progressive disease. The trial compared Tecvayli plus Darzalex against standard of care triple therapies consisting of daratumumab-pomalidomide-dexamethasone (DPd) or daratumumab-bortezomib-dexamethasone (DVd).
Results, revealed in an abstract ahead of the 2025 American Society of Hematology (ASH) meeting, set to be held December 6–9, showed the J&J combo led to an 83% improvement in progression-free survival (PFS) versus controls. This effect was highly statistically significant, with a p-value of less than 0.0001. PFS at 36 months was 83.4% with the Tecvayli/Darzalex combo, versus 29.7% on the current standard regimen.
Overall survival (OS) data were likewise strongly in favor of Tecvayli plus Darzalex, which cut the rate of deaths by 54% versus controls. OS at 36 months was 83.3% among patients treated with the J&J regimen, as compared with 65.0% in comparators.
Guggenheim analysts “believe these data could represent a paradigm shift in the treatment of patients with RRMM,” they wrote, however noting that they still need to see full data at ASH.
First approved in October 2022 for RRMM, Tecvayli is a bispecific antibody that targets both the BCMA protein found on multiple myeloma cells and the CD3 receptors found on T cells. Through this mechanism of action, Tecvayli facilitates the immune system’s anticancer activity.
Since its approval, Tecvayli has become one of J&J’s fastest-growing franchises. Last year, the drug’s sales surged to $549 million—a 38.8% year-on-year increase. “A label expansion into the 1-3 prior lines of therapy setting would significantly expand the addressable patient population for Tecvayli,” Guggenheim said.
The MajesTEC-3 readout, the analysts continued—alongside the pharma’s push to test the Tecvayli with other drugs and in other forms of multiple myeloma—“positions JNJ’s multiple myeloma franchise to continue to serve as a key growth driver for the company’s Innovative Medicines business going forward.”
