Treatment with Tecvayli (teclistamab) was better than standard therapies at delaying disease progression and prolonging survival among previously-treated myeloma patients in a Phase 3 clinical trial, according to top-line results announced by the therapy’s developer, Johnson & Johnson.
“The impressive results show a significant improvement in progression-free and overall survival as a monotherapy in patients with refractory multiple myeloma,” Roberto Mina, MD, an Emory University professor who has provided consulting, advisory, and speaking services to J&J, said in a company press release.
The Phase 3 MajesTEC-9 trial (NCT05572515) enrolled more than 600 people with relapsed or refractory myeloma after one to three prior lines of therapy. To join the study, patients had previously received an anti-CD38 therapy and lenalidomide (sold as Revlimid and generics). Most participants’ cancer was refractory to both treatments, meaning it had stopped responding.
Trial tests Tecvayli against standard treatment options
Participants in MajesTEC-9 were randomly assigned to receive Tecvayli alone or one of two standard-of-care combination treatments that are approved for second-line myeloma patients. The trial’s main goal was to compare how long patients lived without their disease getting worse or passing away.
J&J announced that the trial hit its main goal: compared with standard care, Tecvayli reduced the risk of disease progression or death by 71%. The risk of death was reduced by 40% with Tecvayli versus standard therapy, and safety findings were consistent with Tecvayli’s known profile, according to the company. J&J did not share additional details, saying results will be presented at an upcoming medical meeting and shared with regulators worldwide.
“The MajesTEC-9 results reinforce the potential of Tecvayli to transform treatment earlier in the multiple myeloma journey, with an immunotherapy regimen widely available for all appropriate patients, including those commonly treated in the community setting,” Mina said.
How Tecvayli helps the immune system attack myeloma cells
Tecvayli is a type of antibody therapy designed to bring immune cells and myeloma cells together. It binds to BCMA, a marker on myeloma cells, and CD3, a marker on T-cells that help kill cancer cells. This “two-target” approach is meant to help T-cells recognize and attack myeloma more effectively.
The MajesTEC-9 results follow findings from another Phase 3 trial called MajesTEC-3 (NCT05083169). In that study, Tecvayli combined with J&J’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) performed better than standard treatment options for myeloma patients who had received one to three lines of therapy. Based on those results, J&J has sought approval of the Tecvayli/Darzalex Faspro combination as a second-line therapy in the U.S., Brazil, and the European Union.
“TECVAYLI continues to break new ground as a first-in-class bispecific T-cell engager antibody and the MajesTEC-9 results are the latest example of Johnson & Johnson’s commitment to provide critical treatment options for patients at every stage of their disease,” said Yusri Elsayed, MD, PhD, global therapeutic head, oncology, Johnson & Johnson Innovative Medicine. “In addition to the other transformational therapies in our multiple myeloma portfolio, we continue to redefine the future for patients, bringing us another step closer to cure.”
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