Following a strong early showing of Tecvayli and Darzalex Faspro in newly diagnosed multiple myeloma patients last month, Johnson & Johnson is making the case for its oncology cocktail as a potential second-line therapy for the blood cancer.
In the late-stage MajesTEC-3 trial, Tecvayli plus the subcutaneous formulation of J&J’s antibody drug Darzalex beat standard-of-care therapy at helping multiple myeloma patients live longer without their cancer progressing, satisfying the study’s primary endpoint.
The trial enrolled patients with relapsed/refractory multiple myeloma who previously tried one to three prior lines of therapy.
In addition, the results seen with the Tecvayli-Darzalex Faspro combo allowed the trial to meet its secondary endpoint of overall survival (OS), J&J said in an Oct. 16 press release.
“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,” Maria-Victoria Mateos, M.D., Ph.D., a consultant physician in hematology from the University Hospital of Salamanca, said in J&J’s release.
An eventual approval in the second-line setting would significantly advance Tecvayli in the multiple myeloma treatment sequence. As it stands, the drug—a BCMA-targeted bispecific T-cell engager—is only cleared by the FDA for solo use in relapsed or refractory multiple myeloma patients who’ve tried at least four prior lines of therapy.
The drug’s FDA nod is slightly more restrictive than in the EU, where Tecvayli was first cleared by regulators in August 2022 in myeloma patients after at least three prior therapies.
J&J did not disclose comprehensive results from the MajesTEC-3 trial on Thursday, instead noting that the statistical significance of the data inspired an independent data monitoring committee to recommend unblinding the study. The company said it plans to present the results to health authorities and provide detailed data on the Tecvayli combo’s performance at a future medical meeting.
J&J’s phase 3 trial pitted the Tecvayli-Darzalex cocktail against an investigator’s choice of Darzalex Faspro with the immunomodulator pomalidomide and the steroid dexamethasone, or Darzalex Faspro in combination with the proteasome inhibitor bortezomib and dexamethasone.
The Tecvayli-based regimen won out over the control treatments on both progression-free survival and OS, with statistically significant results at almost three years of follow-up, J&J said. The safety of both drugs in the J&J cocktail was on par with their known profiles as monotherapies, the company added.
The positive showing comes shortly after J&J unveiled promising—albeit earlier-stage—signals on Tecvayli and Darzalex Faspro’s potential in the first-line treatment of multiple myeloma.
Last month, J&J said an investigational regimen of Tecvayli and Darzalex Faspro showed “meaningful clinical efficacy” in transplant-eligible patients who were newly diagnosed with multiple myeloma, citing a 100% overall response rate among those who received the combo therapy as their first treatment.
In that midstage study, dubbed MajesTEC-5, 49 patients were treated across three cohorts that included regimens of Tecvayli and Darzalex Faspro with lenalidomide, both with and without bortezomib, J&J said at the time. Aside from the overall response signal, J&J noted that all minimal residual disease (MRD)-evaluable patients were MRD-negative at the end of the trial’s induction period.
Around the time of Tecvayli’s initial FDA nod in October 2022, analysts at SVB Securities estimated that the drug’s sales could eventually eclipse $2 billion at peak. While Tecvayli still has some growing to do to meet those expectations, it’s been no slouch during earnings season, either.
For all of 2024, Tecvayli brought home $549 million, growing sales some 39% over the sum it generated over the course of 2023. And, in 2025’s third quarter, which J&J reported on earlier this week, Tecvayli charted a roughly 60% sales increase to $177 million versus the same period last year.