J&J's Tecvayli Plus Darzalex Faspro Meets Dual Endpoints in Phase III MajesTEC-3 Trial, Poised to Reshape Multiple Myeloma Treatment Paradigm
Johnson & Johnson
Medical Device R&D and Manufacturer
If eventually approved for second-line treatment, Tecvayli's position in the multiple myeloma treatment sequence will be significantly enhanced. Currently, this BCMA-targeted bispecific T-cell engager is only FDA-approved for relapsed/refractory patients who have received at least four prior lines of therapy. Notably, the drug has a more relaxed indication in the EU, where it was approved as early as August 2022 for use in myeloma patients after three prior lines of therapy.
Johnson & Johnson did not disclose specific data but noted that the independent data monitoring committee recommended unblinding based on significant statistical significance. The company plans to submit the results to regulatory authorities and release detailed data at future medical conferences.
This Phase III study had a control group of Darzalex Faspro combined with the immunomodulatory agent pomalidomide/dexamethasone, or the proteasome inhibitor bortezomib/dexamethasone. After nearly three years of follow-up, the Tecvayli regimen demonstrated statistically significant advantages in both co-primary endpoints, with a safety profile consistent with monotherapy.
Previously announced in September, the Phase II MajesTEC-5 study showed that the combination therapy achieved a 100% overall response rate in newly diagnosed transplant-eligible patients, with all evaluable patients reaching minimal residual disease negativity after the end of induction treatment. Additionally, the frontline treatment study MajesTEC-7 for patients unsuitable for stem cell transplantation is evaluating the Tecvayli + daratumumab regimen and the daratumumab combined with GPRC5D-targeted T-cell engager Talvey regimen. Safety lead-in data presented at the 2024 ASCO Annual Meeting demonstrated that the Tecvayli + daratumumab + lenalidomide triplet regimen achieved an objective response rate (ORR) of 92%.
In addition to current therapies, Johnson & Johnson is also actively advancing next-generation treatments. The ongoing Monumental-6 study evaluates Tecvayli combined with Talvey for the treatment of relapsed myeloma. Development is expected to be completed next year for JNJ-79635322, a bispecific T-cell engager targeting both BCMA and GPRC5D. Early data presented at ASCO garnered praise as "comparable to CAR-T therapy."
Some analysts once predicted that the sales peak of Tecvayli could exceed $2 billion. In 2024, the drug achieved sales of $549 million, a year-on-year increase of 39%; in the third quarter of 2025, sales reached $177 million, a year-on-year surge of approximately 60%, showing strong growth momentum.
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