Combination myeloma treatment shows promise in trial
Most patients were free from disease progression after a year, data show
Most people with hard-to-treat multiple myeloma who were given a combination treatment of Talvey (talquetamab-tgvs) and Tecvayli (teclistamab-cqyv) in a clinical trial were alive and free from disease progression after a year, data showed.
Johnson & Johnson, which markets both therapies, detailed the findings at the 2025 European Hematology Association Congress, held June 12-15 in Milan, in a presentation titled, “Phase 2 Study of talquetamab + teclistamab in patients with relapsed/refractory multiple myeloma and extramedullary disease: RedirecTT-1.”
“Our first-in-class bispecific antibodies Talvey and Tecvayli have transformed treatment for relapsed or refractory multiple myeloma,” Jordan Schecter, MD, vice president and disease area leader for multiple myeloma at Johnson & Johnson Innovative Medicine, said in a company press release. Schecter said the study “underscores our commitment to advancing innovative therapies that attack the disease in different ways by building combinable and complementary regimens.”
Myeloma is a type of blood cancer in which certain immune cells grow uncontrolled in the bone marrow. Some people with myeloma will develop extramedullary disease (EMD), in which the cancer cells start to grow in other organs as well. This is typically linked with poorer outcomes.
“Patients with extramedullary myeloma, especially those who have exhausted prior therapies, need more effective treatment options,” Schecter said.
Combining individually approved myeloma treatments
Talvey and Tecvayli are individually approved in the U.S. to treat certain adults with myeloma whose disease is relapsed or refractory, meaning the cancer either failed to respond to prior treatments or came back after initially responding to other treatments. Both therapies work by simultaneously targeting a protein on myeloma cells and a protein on cancer-killing immune cells called T-cells. By binding to both simultaneously, these therapies aim to spur the immune system to more effectively kill cancer cells.
The new data come from an ongoing Phase 1/2 study called RedirecTT-1 (NCT04586426), which is testing the combination of Talvey and Tecvayli in more than 200 people with relapsed or refractory myeloma. In the trial, both Talvey and Tecvayli were given by under-the-skin injection every other week in 28-week cycles. Patients had the option to switch to once-monthly dosing at their doctors’ discretion.
The presentation focused on outcomes from 90 study participants who had EMD. More than 80% of these patients had previously received at least three prior lines of treatment, and more than a third of them had received five or more previous treatments.
Results showed that the overall response rate was 78.9%, meaning more than three out of four patients experienced a reduction in cancer burden following combination treatment with Talvey and Tecvayli. More than half (54.4%) of the patients had a complete response, meaning their cancer went away following the combination therapy. Response rates were similar among patients who had had various types of previous treatments, including CAR T-cell therapies and other bispecific antibody therapies.
About two-thirds (66.2%) of the patients who responded to the combination treatment were still in response as of the latest data cut-off, with a median follow-up time of more than a year. Overall, 74.5% of the trial participants were still alive after one year, and 61% were both alive and free from disease progression after one year.
“The investigational combination of Talvey and Tecvayli has demonstrated deep, durable responses in patients with relapsed or refractory multiple myeloma, and now shows great promise in those with extramedullary myeloma, where standard therapies often fall short,” said Yael Cohen, MD, study investigator and head of the myeloma unit at Tel-Aviv Sourasky Medical Center in Israel.
Safety data from the RedirecTT-1 study have been consistent with the known safety profiles of Talvey and Tecvayli individually. Serious side effects were reported in most of the participants, with the most common being low counts of immune cells. Most patients experienced an inflammatory reaction called cytokine release syndrome, though in most cases this was not serious.
In 10 participants, safety problems proved fatal. Five of those events were due to infections, and the other five were not related to the combination treatment.
Overall, available data from the ongoing clinical trial “[show] the power of this novel dual-targeting combination approach as a potential treatment option for patients with this disease,” Cohen said.
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