New approval urged in Europe for drug’s use in myeloma combo therapy
Committee recommends combo as earlier treatment – for patients' first relapse
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An arm of the European Medicines Agency (EMA) — which reviews clinical trial data for drugs under regulatory review in the European Union — has recommended expanding the indication for Talvey (talquetamab-tgvs), an approved therapy for multiple myeloma.
The new recommendation supports authorizing Talvey in combination with another approved myeloma therapy, Darzalex (daratumumab), to treat people with this blood cancer who have received only one previous line of treatment. Both Talvey and Darzalex are sold by Johnson & Johnson (J&J).
Talvey is now conditionally approved in the EU as a treatment for certain adults with myeloma that has come back (relapsed) or failed to respond (is refractory, or treatment-resistant) following at least three prior therapies. That approval covers the drug’s use on its own, or as a monotherapy.
According to J&J, the combo treatment could be used earlier, and may possibly lead to better outcomes for people with myeloma.
“For patients facing their first relapse, this combination has the potential to provide deep responses and keep their disease under control for longer at a critical point in their treatment journey,” Ester in ’t Groen, J&J’s therapeutic area head for hematology in Europe, the Middle East, and Africa, said in a company press release.
The recommendation comes from the EMA’s Committee for Medicinal Products for Human Use, known as CHMP. The CHMP recommendation will now be reviewed by the European Commission, which has final say over therapy approvals in Europe. The commission isn’t technically required to follow the CHMP’s recommendations, but it almost always does.
“This CHMP recommendation reflects the continued evolution of the [Talvey] program in multiple myeloma, and further strengthens the potential of [Talvey]-based therapies as early as second line, building on our commitment to generate data that can help inform treatment choices based on patients’ prior therapies and disease characteristics,” In ‘t Groen said.
J&J wants to combine its drugs Talvey and Darzalex
The advisory committee’s recommendation was based on data from MonumenTAL-3 (NCT05455320), an ongoing late-stage clinical trial. The study enrolled patients with myeloma that was relapsed or refractory following at least one prior line of treatment, including Revlimid (lenalidomide) and a proteasome inhibitor.
Some participants in MonumenTAL-3 were given treatment with Talvey plus Darzalex Faspro, a subcutaneous, or under-the-skin, injection formulation of Darzalex. Others were given the two medications in addition to a third, Pomalyst (pomalidomide). The remaining patients were treated with an approved regimen consisting of Darzalex, Pomalyst, and dexamethasone, a synthetic, or man-made, corticosteroid.
The study’s main goal is to assess progression-free survival (PFS), defined as the number of patients alive without disease progression at certain time markers. After a median follow-up of more than two years, patients receiving either of the Talvey-based regimens had significantly better PFS than those receiving the approved regimen, the data showed.
At two years, the PFS rate was 81.3% for patients given Talvey, Darzalex, and Pomalyst. For those given just Talvey and Darzalex, the PFS rate was 77.6%. In both groups, slightly less than 90% of patients were still alive after two years.
Safety data from the MonumenTAL-3 study were overall consistent with the known profile of each medication used individually; serious safety complications were reported in nearly all patients, as is typical for people undergoing intensive cancer treatments.
“MonumenTAL-3 demonstrated significant improvements in progression-free survival, overall survival, response rates and depth of response with the combination of talquetamab and daratumumab,” In ‘t Groen said.
This … combination leverages the power of our portfolio by bringing together [Talvey] with the well-established therapy of [Darzalex].
Myeloma is a cancer marked by the uncontrolled growth of plasma cells in the bone marrow, the spongy tissue at the center of certain bones. Talvey and Darzalex are both antibody-based medications that target proteins expressed by these cells. Specifically, Talvey targets GPRC5D, and Darzalex targets CD38.
“At Johnson & Johnson, our strategy is grounded in pursuing differentiated immunotherapy approaches earlier in the disease course to address diverse patient characteristics and the evolving complexity of multiple myeloma,” said Yusri Elsayed, MD, PhD, J&J’s global therapeutic area head for oncology, who noted that the combination treatment would be readily available to patients, known as off-the-shelf.
“This off-the-shelf, immunotherapy-based combination leverages the power of our portfolio by bringing together [Talvey] with the well-established therapy of [Darzalex],” Elsayed said. “By simultaneously targeting GPRC5D and CD38, our goal is to deliver deeper and longer lasting responses for patients.”
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