Teclistamab plus daratumumab improved rates of progression-free survival and measurable residual disease –negative complete response for patients with relapsed or refractory multiple myeloma regardless of high-risk cytogenetic abnormalities (HRCAs) or functional high-risk (FHR) status, according to a post-hoc subgroup analysis of the MajesTEC-3 trial presented at the 2026 EHA Congress in Stockholm, Sweden.
The findings support teclistamab plus daratumumab as a steroid-sparing standard of care as early as first relapse, regardless of risk status, said presenting author Rahul Banerjee, MD, FACP, of Fred Hutchinson Cancer Center in Seattle, Washington.
The MajesTEC-3 trial compared teclistamab plus daratumumab with standard daratumumab plus dexamethasone and pomalidomide or bortezomib (DPd/DVd). In the previous primary analysis, teclistamab plus daratumumab met the primary PFS endpoints and all key secondary endpoints including CR or better, MRD negativity, and overall survival rates.
In the post-hoc analysis, the prespecified definition of high risk was one or more of the following HRCAs: t(4;14), t(14;16), or deletion 17p. The high risk definition was later revised to include two additional HRCAs: three copies of gain(1q21) or four or more copies of amp(1q21). FHR was defined as one prior line of therapy plus progressive disease within 18 months of autologous stem cell transplantation or start of initial therapy. The analysis reported on the following subgroups: prespecified standard-risk or high-risk; revised standard-risk or high-risk; one or two or more HRCAs, and FHR or non-FHR.
After a median follow-up of 34.5 months, teclistamab plus daratumumab had more favorable PFS and higher MRD-negative CR rates compared with DPd/DVd across all HRCA and FHR subgroups. Specifically, the estimated 36-month PFS rates for teclistamab plus daratumumab versus DPd/DVd were 87.4% versus 37.1% in prespecified standard-risk patients and 77.7% versus 11.5% in high-risk patients, respectively. In the FHR subgroup, estimated 36-month PFS rates were 77.3% with teclistamab plus daratumumab versus 0% with DPd/DVd (HR, 0.22; 95% CI, 0.08-0.62). Teclistamab plus daratumumab was also favored versus DPd/DVd in patients with one prior line of therapy without FHR status.
The post-hoc analysis findings build on the positive results from the primary MajesTEC-3 analysis and support that teclistamab plus daratumumab attenuate the poor prognosis associated with high-risk relapsed or refractory multiple myeloma, Dr. Banerjee and colleagues wrote.
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