New combination therapy cuts risk of death in hard-to-treat myeloma
Dual treatment worked better than standard care, trial data show
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A combination treatment using two Johnson & Johnson immunotherapies outperformed standard care regimens in reducing the risk of disease progression and death among people with previously-treated myeloma.
That’s according to new data from a late-stage clinical trial that tested Talvey (talquetamab) plus Tecvayli (teclistamab) as a combination therapy for people with hard-to-manage myeloma. The dual-med strategy was seen to specifically cut the risk of death by more than 60% compared with the use of standard treatment.
Johnson & Johnson, which markets both Talvey and Tecvayli, announced the top-line results from the Phase 3 study in a company press release. Both medications are already approved in the U.S. as part of other regimens used for treatment-resistant myeloma.
“These findings further reinforce immunotherapy as a cornerstone of multiple myeloma care,” said Yusri Elsayed, MD, PhD, global therapeutic area head for oncology at Johnson & Johnson. “By continuing to expand treatment options across the disease continuum, we are moving closer to our ambition of one day curing this disease.”
Elsayed added: “At Johnson & Johnson, we have intentionally built a multiple myeloma portfolio that spans biological targets, mechanisms, modalities and lines of therapy, giving physicians the flexibility to use our therapies across a diverse patient population and throughout the patient journey.”
Myeloma is a form of blood cancer characterized by the uncontrolled growth of immune cells called plasma cells in the bone marrow, the spongy center of bones. Both Talvey and Tecvayli belong to a class of immunotherapies called bispecific T-cell engagers, or BiTEs. These therapies work by simultaneously sticking to proteins on myeloma cells and proteins on T-cells, which are immune cells that are able to kill cancer cells.
Essentially, these therapies aim to bring killer immune cells in close contact with myeloma cells, allowing the T-cells to eradicate the cancerous cells.
Talvey specifically targets a myeloma protein called GPRC5D, while Tecvayli zeroes in on another myeloma protein called BCMA. Both therapies are given subcutaneously, or by injection under the skin.
Combo therapy tested in large, late-stage trial
The Phase 3 MonumenTAL-6 clinical trial (NCT06208150) enrolled about 800 people with myeloma that was relapsed or refractory, meaning the cancer had failed to respond to prior treatments or had come back after initially responding. All participants had received 1-4 prior lines of treatment, including the immunomodulatory agent Revlimid (lenalidomide) and a CD38 inhibitor.
In the global trial, conducted across more than 200 study sites, the participants were divided into three groups.
The first group received combination therapy with Talvey and Tecvayli. The second group was given Talvey in combination with an immunomodulatory agent called Pomalyst (pomalidomide). The third group received a standard treatment combo using Pomalyst, the corticosteroid dexamethasone, and either Empliciti (elotuzumab) or Velcade (bortezomib) at their doctor’s discretion.
The results showed that, compared with the standard combo, treatment with Talvey and Tecvayli decreased the risk of progression or death by 89%, with the risk of death specifically reduced by 62%. The combination of Talvey and Pomalyst also outperformed standard therapy, reducing the risk of disease progression or death by 73%, the data showed.
Talvey and Tecvayli together generated deep and durable responses, … further reinforcing the potential of this off-the-shelf [readily available] regimen to improve outcomes for patients.
Across all treatment combinations, safety data were in line with the known profiles of each medication used, the researchers noted.
“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 K. Nooka, MD, director of the Emory University School of Medicine’s myeloma program. Nooka has provided consulting, advisory, and speaking services to Johnson & Johnson.
“Talvey and Tecvayli 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 [readily available] regimen to improve outcomes for patients across practice settings,” Nooka said.
Full results from this Phase 3 trial will be presented at a future major medical meeting and shared with global health authorities, the company said.
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