Myeloma treatment Tecvayli extends survival, trial data show

Tecvayli (teclistamab) extended survival and kept disease under control longer than standard treatments in patients with relapsed or refractory multiple myeloma, meaning the disease had returned or stopped responding to treatment, trial data showed.

The results support Johnson & Johnson’s regulatory filings in the U.S. and European Union to expand Tecvayli’s approval for use as early as the second-line treatment setting.

The data come from MajesTEC-9 (NCT05572515), a Phase 3 clinical study testing the safety and efficacy of Tecvayli compared with standard pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients who have received at least one line of myeloma treatment, including an anti-CD38 antibody and lenalidomide.

“These latest data add further clinical evidence supporting the potential of [Tecvayli]-based regimens to move into earlier lines of treatment and to become a potential new standard of care as early as the second line,” Ester in ’t Groen, PhD, therapeutic area head of hematology at Johnson & Johnson Europe, Middle East, and Africa, said in a company press release.

The data were published in The New England Journal of Medicine in the study, “Teclistamab in Multiple Myeloma with One to Three Previous Lines of Therapy.” Roberto Mina, MD, an associate professor at the Winship Cancer Institute of Emory University, also presented the results in an oral session at the recent American Society of Clinical Oncology annual meeting in Chicago.

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Multiple myeloma is a cancer that develops in plasma cells, a type of blood cell found in the bone marrow. When these plasma cells multiply uncontrollably, they crowd out healthy blood cells, causing myeloma symptoms such as fatigue and frequent infections. Most patients eventually relapse or stop responding to standard treatments.

“Triplet [three-medication] and quadruplet [four-medication] regimens have greatly improved outcomes in newly diagnosed multiple myeloma, yet a high unmet need remains for more effective, broadly accessible treatments,” Mina wrote in his presentation. This holds true for patients who relapse or stop responding to targeted treatments such as an anti-CD38 antibody or lenalidomide.

Tecvayli is a bispecific antibody, a type of engineered antibody designed to bind to two targets at the same time. One end binds to BCMA, a protein found on myeloma cells, while the other binds to CD3, a protein present on T-cells, immune cells responsible for destroying abnormal cells. By bringing T-cells directly to myeloma cells, Tecvayli helps the immune system recognize and destroy the cancer.

The MajesTEC-9 clinical study involved 593 patients, aged 34 to 86, who had received a median of two prior lines of treatment for multiple myeloma. The main goal was to evaluate changes in progression-free survival, which measures how long patients live without their disease worsening. Researchers also compared overall survival.

Of the 593 patients, 296 received Tecvayli in 28-day cycles, and 297 received PVd or Kd in cycles of 21 or 28 days. After 18 months (1.5 years), the estimated progression-free survival was significantly higher with Tecvayli than with standard treatment (69.8% vs. 26.9%). Tecvayli also reduced the risk of disease progression or death by 71%.

Overall survival was also significantly higher with Tecvayli (79.2% vs. 68.6%), reducing the risk of death by 40% compared with standard treatment. In addition, about four times as many patients achieved a complete response or better with Tecvayli than with standard treatment (65.9% vs. 16.8%). A complete response means no signs of detectable cancer are found using current testing.

“These findings further reinforce teclistamab’s potential to meaningfully improve survival outcomes for patients with multiple myeloma in earlier lines,” Mina said. “These results will continue to transform the role of bispecifics in clinical decision-making as early as second line — offering a steroid-sparing, community-based therapy for patients across all practice settings, regardless of prior anti-CD38 exposure.”

Steroids can help stop myeloma cells from multiplying, but they can cause serious side effects when used at high doses or for long periods.

The safety profile of Tecvayli was consistent with previous studies. Almost all patients experienced side effects during treatment in both groups. However, severe side effects, including severe infections, were more common with Tecvayli than with standard treatment (84.9% vs. 76.3%). Cytokine release syndrome, a heightened inflammatory response, occurred in about two-thirds (66%) of patients on Tecvayli.

“These data add to the growing body of evidence reinforcing the clinical power of [Tecvayli] earlier in the treatment paradigm,” said Yusri Elsayed, MD, PhD, global therapeutic area head of oncology at Johnson & Johnson, “further [demonstrating] how we’re leading in multiple myeloma as we bring new options to better match the right therapy to the right patient at each stage of disease.”