J&J Report Positive Results from Combination of Multiple Myeloma Immunotherapies

Rare Daily Staff

Johnson & Johnson said Thursday that an experimental combination of its multiple myeloma drugs Tecvayli and Talvey significantly lowered the risk of disease progression or death in a late-stage trial involving patients with relapsed or refractory blood cancer.

Multiple myeloma is a cancer of plasma cells, a type of white blood cell found in the bone marrow. The disease remains difficult to treat, particularly after it returns or stops responding to treatment, making new therapy combinations closely watched by oncologists.

Tecvayli and Talvey are both bispecific antibodies, a type of treatment that links T cells to myeloma cells so the immune system can attack the cancer. Tecvayli targets BCMA, while Talvey targets GPRC5D. Both also bind to CD3 on T cells to trigger an immune response.

In the phase 3 MonumenTAL-6 study, the Tecvayli-plus-Talvey regimen reduced the risk of progression or death by 89 percent and the risk of death by 62 percent compared with standard treatment options, the company said. The trial enrolled adults who had received one to four prior lines of therapy, including an anti-CD38 antibody and lenalidomide.

The findings suggest that a dual-immunotherapy approach could move earlier in the treatment sequence for a hard-to-treat cancer that often returns after initial therapy. Johnson & Johnson said MonumenTAL-6 is the first and only phase 3 study of a dual-antigen regimen targeting BCMA and GPRC5D in relapsed or refractory multiple myeloma.

Johnson & Johnson said the safety profile was consistent with what is already known about each drug, and the study’s monitoring committee recommended unblinding the trial early because of the strength of the data. The company said full results will be presented at a future medical meeting and shared with regulators.

“These findings add to a growing body of phase 3 evidence evaluating the survival outcomes associated with the early use of immunotherapy doublets in the treatment journey,” said Ajay Nooka, director of the myeloma program in the department of hematology and medical oncology at Emory University School of Medicine. “Tecvayli and Talvey together generated deep and durable responses, demonstrating what’s possible by targeting BCMA and GPRC5D at the same time, and further reinforcing the potential of this off-the-shelf regimen to improve outcomes for patients across practice settings.”