Phase III Data Support Johnson & Johson’s Teclistamab as Second-Line Therapy for RRMM

Johnson & Johnson has submitted a Type II variation application to the European Medicines Agency seeking approval to expand the indication of teclistamab (brand name Tecvayli), a bispecific antibody (bsAb), as monotherapy for adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy. The filing is supported by data from a Phase III trial (MajesTEC-9) evaluating teclistamab against established second-line regimens.¹

Results from the trial demonstrated superior progression-free survival and overall survival compared with standard-of-care combinations, which suggests the potential for earlier use of bispecific T-cell–redirecting immunotherapy in multiple myeloma treatment pathways, according to the company in a March 10, 2026 press release.

“At Johnson & Johnson, we are driven by a clear purpose to deliver innovations that redefine expectations of what a multiple myeloma diagnosis means to patients, at every stage of the disease,” said Jordan Schecter, MD, vice president, Disease Area leader, Multiple Myeloma, Johnson & Johnson, in the release.¹ “With today’s regulatory milestone for teclistamab, we are advancing a widely available immunotherapy approach with the potential to support deep and sustained responses over time.”

How does teclistamab compare with current second-line treatment options?

The Phase III MajesTEC-9 study enrolled 614 patients with RRMM who had received one to three prior lines of therapy. Most patients were heavily pretreated, with 85% refractory to anti-CD38 monoclonal antibodies and 79% refractory to lenalidomide.² In the randomized trial, teclistamab monotherapy was compared with physician’s choice of PVd or Kd regimens, both widely used second-line treatment options.

Investigators reported a 71% reduction in the risk of disease progression or death compared with pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) regimens. Teclistamab also reduced the risk of death by 40% in a patient population largely refractory to prior anti-CD38 monoclonal antibody and lenalidomide therapies.²

“A significant number of patients with multiple myeloma continue to relapse and become refractory to currently available therapies, representing one of the largest and most challenging unmet needs in the disease,” said Ester in ’t Groen, EMEA therapeutic area head, Hematology, Johnson & Johnson, in a company press release.¹ “Making teclistamab monotherapy available to patients as early as second line, where it has the potential to meaningfully improve long-term outcomes and change the course of the disease, could bring new hope to patients and their families.”

The therapy’s safety profile was reported as manageable and consistent with previously observed data. No new safety signals were identified, and infection risks were addressed through established monitoring strategies, immunoglobulin therapy, and antimicrobial prophylaxis protocols.

Could earlier bsAb use reshape multiple myeloma treatment sequencing?

Teclistamab redirects T cells by simultaneously targeting B-cell maturation antigen on malignant plasma cells and CD3 on T cells, activating immune-mediated tumor cell killing. The bsAb received approval from the European Commission in 2022 for patients with RRMM who had received at least three prior lines of therapy. A subsequent regulatory update in 2023 introduced a reduced dosing frequency for patients achieving sustained complete responses.

Expanding teclistamab use into earlier lines of therapy could represent a shift in treatment sequencing, potentially positioning bispecific immunotherapies alongside or ahead of existing combination regimens for patients whose disease progresses after frontline therapy.³

Full Phase III study results are expected to be presented at a future major medical meeting as part of ongoing regulatory submissions globally, the company stated.¹

References

1. Johnson & Johnson. TECVAYLI (teclistamab) monotherapy application submitted to the EMA for relapsed/refractory multiple myeloma after at least one prior therapy. Press Release. March 10, 2026.
2. Johnson & Johnson. TECVAYLI monotherapy demonstrates superior progression-free and overall survival versus standard of care as early as first relapse in patients with multiple myeloma predominantly refractory to anti-CD38 therapy and lenalidomide. Press Release. Jan. 14, 2026.
3. Devasia AJ, Chari A, Lancman G. Bispecific antibodies in the treatment of multiple myeloma. Blood Cancer J. 2024;14:158. doi 10.1038/s41408-024-01139-y