EU panel backs earlier use of approved treatment for multiple myeloma

An arm of the European Medicines Agency (EMA) has recommended expanding the European approval of Johnson & Johnson‘s Tecvayli (teclistamab) to treat adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy.

The recommendation, which comes from the EMA’s Committee for Medicinal Products for Human Use (CHMP), will now be reviewed by the European Commission. The commission, which has final say over therapy approvals in the EU, isn’t technically required to follow the CHMP’s recommendations but almost always does.

“This positive CHMP opinion reflects the importance of [Tecvayli] in multiple myeloma and further reinforces its potential as a foundational immunotherapy after first-line treatment,” Ester in ’t Groen, PhD, therapeutic area head of hematology at J&J Europe, Middle East, and Africa, said in a company press release.

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Tecvayli targets two key proteins

Multiple myeloma is a form of blood cancer marked by the uncontrolled growth of immune cells in the bone marrow. RRMM refers to myeloma that has failed to respond to or has returned after initial treatments.

Tecvayli is a bispecific antibody therapy that works by simultaneously sticking to BCMA, a protein on myeloma cells, and CD3, a protein on cancer-killing immune cells, called T-cells. By targeting both at the same time, the therapy essentially prompts T-cells to attack the cancer more effectively.

Currently, Tecvayli is approved in the EU to treat certain adults with RRMM who have received at least three prior lines of therapy. The CHMP’s recommendation, if approved, would expand the therapy’s indication to include earlier use in the treatment journey. The CHMP recently made a similar recommendation to expand the authorization of a regimen that combines Tecvayli with another approved myeloma treatment, daratumumab, sold as Darzalex and Darzalex Faspro. The European Commission has since approved that regimen to be started earlier.

“Relapsed or refractory multiple myeloma remains a complex disease, with diverse and evolving patient needs. … By providing steroid-sparing combination and monotherapy [single-agent] regimens, [Tecvayli] has the potential to expand the choices for patients living with the disease and redefine what’s possible in multiple myeloma,” in ’t Groen said.

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Recommendation based on Phase 3 trial results

The new CHMP recommendation for Tecvayli as a standalone treatment in RRMM patients after one prior line of therapy is based on data from a Phase 3 trial called MajesTEC-9 (NCT05572515). The study compared Tecvayli against two approved regimens — pomalidomide, bortezomib, and dexamethasone or carfilzomib and dexamethasone — in more than 500 people with RRMM who had received one to three prior lines of treatment.

Results showed that, after 18 months, rates of progression-free survival (that is, the number of patients who were alive without disease progression) were significantly higher among patients given Tecvayli (69.8% vs. 26.9%). Overall survival rates were also higher with Tecvayli (79.2% vs. 68.6%), and safety outcomes were consistent with Tecvayli’s known profile.

Yusri Elsayed, MD, PhD, J&J’s global therapeutic area head for oncology, said the new CHMP opinion “reflects our longstanding commitment to transforming outcomes for patients with multiple myeloma by advancing innovative therapies, such as [Tecvayli], into earlier lines of treatment, where they have the greatest potential to change the trajectory of the disease.”

“By investing across the treatment continuum, from established foundations of care to novel immunotherapies, we remain focused on delivering differentiated treatment options that address patients’ diverse needs at every stage of their disease, all with the goal of improving long-term outcomes and, where possible, moving people closer to durable remission and, ultimately, cure,” Elsayed added.