Tecvayli-Darzalex Faspro combo extends survival in myeloma trial
J&J exec says treatment combo 'poised to be a new standard of care option'
People with hard-to-treat myeloma given a combination of Tecvayli (teclistamab) and Darzalex Faspro (daratumumab and hyaluronidase-fihj) — both approved cancer therapies from Johnson & Johnson (J&J) — in a clinical trial had significantly longer overall survival than patients receiving standard of care treatment, according to top-line results announced by the company.
Additionally, trial participants on the combo experienced significant improvements in progression-free survival, or PFS — meaning they lived longer without their disease getting worse — compared with those on standard treatment, the new data show.
Further, the overall safety profile of the medications in combination was “consistent” with that of each therapy used individually, per a company press release.
“We are confident this combination is poised to be a new standard of care option” for people with myeloma, said Yusri Elsayed, MD, PhD, global therapeutic area head, oncology, at Johnson & Johnson Innovative Medicine.
Myeloma is a type of blood cancer caused by the uncontrolled growth of immune cells called plasma cells. Tecvayli and Darzalex Faspro are approved treatments for myeloma, both given via subcutaneous, or under-the-skin, injection, that are sold by J&J.
Tecvayli is indicated in the U.S. for adults with relapsed or refractory (treatment-resistant) multiple myeloma who have received at least four prior lines of therapy. It works by simultaneously binding to BCMA, a protein on myeloma cells, and CD3, a protein on T cells. This dual targeting brings T cells into close proximity with myeloma cells, activating the immune cells to kill the cancer cells.
Darzalex Faspro, meanwhile, is approved in the U.S. as part of various combination regimens for both newly diagnosed and previously treated multiple myeloma. This therapy targets CD38, a protein highly expressed on myeloma cells, leading to their destruction through immune-mediated mechanisms.
“Tecvayli and Darzalex Faspro uniquely work together to target both BCMA and CD38 simultaneously, priming and activating the immune system and eliminating myeloma cells,” said Maria-Victoria Mateos, MD, PhD, a consultant physician in hematology at the University Hospital of Salamanca who has acted as a paid consultant and speaker for Johnson & Johnson.
Large clinical trial tested combo of Tecvayli and Darzalex Faspro
In 2021, J&J sponsored a Phase 3 clinical trial called MajesTEC-3 (NCT05083169) to test the combination of Tecvayli and Darzalex Faspro in people with myeloma who had received one to three prior lines of therapy.
The study enrolled more than 500 patients, all of whom were treated with Darzalex Faspro. Some patients were also given Tecvayli, while others received standard-of-care Darzalex combos using dexamethasone and either Pomalyst (pomalidomide) or bortezomib (sold as Velcade and generics).
The study’s main goal was to see if the combination of Tecvayli and Darzalex Faspro would lead to longer PFS, referring to the time patients remain alive without the disease getting worse. A key secondary goal was to see if the treatment would prolong overall survival.
These results demonstrate the clinical benefits of Tecvayli in earlier lines when used in combination, as evidenced by meaningful progression-free survival and overall survival outcomes.
According to J&J, the trial met both these goals, with data showing Tecvayli and Darzalex Faspro given together led to statistically significant improvements in both PFS and overall survival relative to standard of care therapies.
The data also show the benefits of Tecvayli, typically used later in treatment, when given to patients earlier, the company noted.
“These results demonstrate the clinical benefits of Tecvayli in earlier lines when used in combination, as evidenced by meaningful progression-free survival and overall survival outcomes,” Mateos said.
J&J said the combination of Tecvayli and Darzalex Faspro showed a safety profile consistent with each therapy individually. The company did not provide further details on the results, noting that in-depth findings will be presented at a future scientific meeting and shared with regulatory authorities.
Overall, however, Elsayed said the results “demonstrate Johnson & Johnson’s leadership in developing regimens with complementary and synergistic mechanisms of action for patients with multiple myeloma.” Elsayed added that the improvement in survival seen for trial participants “is another example of how our portfolio is fundamentally transforming how patients with multiple myeloma are treated.”
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