EU clears Tecvayli as solo option when myeloma returns after first treatment

The European Commission has cleared Tecvayli (teclistamab-cqyv) as a monotherapy, meaning it can be given on its own, for adults whose myeloma returned or stopped responding after their initial therapy.

Tecvayli was recently approved in the EU as a second-line treatment for myeloma when combined with daratumumab (sold as Darzalex or Darzalex Faspro). The new decision means clinicians can now prescribe Tecvayli by itself without pairing it with a second targeted drug for patients with myeloma that has come back (relapsed) or failed to respond (refractory) after one prior line of treatment. The approval was announced by Johnson & Johnson (J&J), which markets Tecvayli, Darzalex, and Darzalex Faspro.

“Building on the recent approval of [Tecvayli] plus daratumumab, this European Commission [decision] further reinforces the strength of bispecific-based immunotherapy approaches as early as second line,” 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.

Cyrille Touzeau, MD, PhD, a professor at University Hospital of Nantes in France who has consulted for J&J, noted that the decision “gives physicians an additional immunotherapy option in the second-line setting, supported by significant improvements in both progression-free and overall survival.”

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Myeloma is a cancer that occurs when plasma cells, a type of immune cell, grow out of control in the bone marrow. A range of treatments is currently available, but sometimes the first line of therapy isn’t sufficient to control the cancer.

“Patients with relapsed or refractory multiple myeloma often experience shorter remissions and diminishing responses with each subsequent line of therapy, making effective treatment at first relapse increasingly important,” Touzeau said.

Tecvayli is an under-the-skin injection therapy that works by simultaneously sticking to myeloma cells and to cancer-killing immune cells called T-cells, triggering them to attack and kill the cancer. The monotherapy approval comes just weeks after a positive recommendation from an arm of the European Medicines Agency, and was based on data from a Phase 3 trial called MajesTEC-9 (NCT05572515).

That trial evaluated Tecvayli against two approved regimens in patients with relapsed or refractory disease following one to three prior lines of treatment. Participants receiving Tecvayli lived significantly longer and had a significantly lower likelihood of disease progression, with safety data in line with the therapy’s known profile.

“With nearly two-thirds of patients achieving a complete response or better, the results seen with [Tecvayli] are encouraging and demonstrate the depth of response achieved in the study,” Touzeau said. (A complete response or better means that patients do not have detectable cancer following treatment.)

The earlier approval of Tecvayli in combination with daratumumab was based on findings from another trial, MajesTEC-3 (NCT05083169), which similarly showed that this combination outperformed older regimens at reducing the odds of disease progression and improving chances of survival.

“Together, the MajesTEC-3 and MajesTEC-9 studies support the potential of [Tecvayli]-based therapies to advance the treatment paradigm and improve outcomes for patients earlier in their disease journey,” in ’t Groen said.