Approval urged in Europe for earlier use of combo therapy in myeloma
For second go, committee recommends Tecvayli plus daratumumab regimen
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A regulatory committee in the European Union has recommended expanding approval of a dual regimen for hard-to-treat myeloma — one using both Tecvayli (teclistamab) and daratumumab — to allow the combo therapy to be started earlier.
The combo is now approved in the EU to treat people with myeloma whose cancer is relapsed or refractory, meaning it’s failed to respond, or came back after initially responding, following at least three lines of treatment. The new recommendation would expand its approval, allowing the regimen to be used for individuals whose cancer has relapsed or is refractory after just one line of treatment.
According to Johnson & Johnson (J&J), which markets both Tecvayli and daratumumab, this recommendation, if followed, may help slow cancer worsening among patients, and “advances [the combination of these two medicines] as a potential standard of care for relapsed/refractory multiple myeloma.”
Tecvayli was first approved in the EU in 2022. Daratumumab is available as an intravenous, or into-the-vein, infusion, sold as Darzalex, or as a subcutaneous, or under-the-skin, injection sold as Darzalex Faspro.
“Pending approval, this novel complementary immunotherapy combination is positioned to delay disease progression for patients treated as early as second line,” J&J stated in a company press release announcing the recommendation.
The recommendation came from the Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency that’s tasked with reviewing data on medications under consideration for approval in the EU. The CHMP’s recommendation will now be reviewed by the European Commission, which has final say over therapy approvals in the EU. The Commission isn’t technically required to follow the CHMP’s recommendations, but it almost always does.
Tecvayli and daratumumab both are designed to weaponize the immune system to destroy myeloma cells. Tecvayli works by simultaneously binding to a myeloma protein called BCMA and another protein called CD3, which is expressed by cancer-killing immune cells. Daratumumab, meanwhile, targets a myeloma protein called CD38. Both therapies are widely approved for use in various regimens as treatments for myeloma.
“At Johnson & Johnson our ambition is to leverage the full potential of our comprehensive multiple myeloma portfolio, to strengthen patient outcomes at every stage of the treatment continuum,” said Yusri Elsayed, MD, PhD, J&J’s global therapeutic area head, oncology. “By advancing innovative immunotherapies such as [Tecvayli] and combining them with a well-established standard of care like daratumumab, we are building on our deep scientific expertise to deliver more integrated, combination-based approaches that can continue to raise expectations for patient care.”
Use of combo therapy approved in US earlier this year
The combination of Tecvayli and Darzalex Faspro, the injection version of daratumumab, was approved in the U.S. a few months ago as a treatment for patients with relapsed or refractory myeloma following one prior line of therapy.
That approval, and the CHMP’s new opinion, were both based mainly on data from an ongoing Phase 3 clinical trial called MajesTEC-3 (NCT05083169).
The MajeTEC-3 study enrolled more than 500 people with myeloma who had relapsed or refractory disease following one to three prior lines of treatment. Participants were randomly assigned to receive Tecvayli and Darzalex Faspro, or one of two previously approved regimens using Darzalex Faspro in combination with other treatments.
Over a median follow-up of three years, more than 80% of patients given the Tecvayli and Darzalex Faspro regimen were alive and free from cancer progression, whereas most patients on other regimens had experienced cancer progression or died, trial data showed. Safety data were comparable across regimens, with nearly all patients experiencing serious side effects, such as low blood cell counts or infections.
This CHMP opinion marks an important step [toward] establishing the off-the-shelf immunotherapy combination of [Tecvayli] plus daratumumab as a new standard of care earlier in the treatment pathway for multiple myeloma.
In the release, J&J noted that “83% of patients [were] alive at three years” following use of the Tecvayli-daratumumab therapy combo.
According to Ester in ’t Groen, J&J’s therapeutic area head for hematology in Europe, the Middle East, and Africa, “this CHMP opinion marks an important step [toward] establishing the off-the-shelf immunotherapy combination of [Tecvayli] plus daratumumab as a new standard of care earlier in the treatment pathway for multiple myeloma.”
Trial results “[highlight] the potential for durable long-term disease control,” in ’t Groen said.
“Unprecedented data show a meaningful extension in overall survival and minimal progression events observed after the first six months. More than 90% of patients receiving the combination who were progression-free at six months remained progression-free at three years,” in ’t Groen said.
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