Johnson & Johnson reported that its bispecific antibody TECVAYLI® (teclistamab‑cqyv) combined with DARZALEX FASPRO® (daratumumab‑hyaluronidase‑fihj) achieved an 83 % reduction in the risk of disease progression or death compared with investigator‑chosen standard regimens in the Phase 3 MajesTEC‑3 study of relapsed/refractory multiple myeloma patients. The combination also produced an overall response rate of 89 % versus 75 % in the control arm, a 58 % rate of minimal residual disease negativity, and a 91 % progression‑free survival rate at three years among patients who were progression‑free at six months.
The results demonstrate the synergistic effect of targeting both BCMA and CD38, the two most frequently expressed antigens on myeloma cells. By combining TECVAYLI’s bispecific mechanism with DARZALEX FASPRO’s rapid, outpatient‑friendly delivery, the regimen offers a steroid‑sparing, well‑characterized safety profile while delivering outcomes that could set a new standard of care in second‑line multiple myeloma. The data strengthen Johnson & Johnson’s oncology portfolio and position the company ahead of other bispecific and CAR‑T competitors.
Safety data from the study show that Grade 3/4 treatment‑emergent adverse events were similar between the combination and control arms, with cytopenia and infection being the most common serious events. Infections were frequent in the TECVAYLI + DARZALEX FASPRO arm but declined after the first six months as established management protocols were applied. Neurologic toxicity, including ICANS, was observed but remained manageable. These findings support the regimen’s tolerability in a real‑world outpatient setting.
Dr. Maria‑Victoria Mateos, a consultant hematologist, highlighted the clinical impact: “The combination of TECVAYLI and DARZALEX FASPRO offers remarkable efficacy, a well‑characterized safety profile with robust infection management protocols, and an opportunity to improve patient outcomes across academic and community settings. It has the potential to change the standard of care as a steroid‑sparing combination regimen suited for outpatient administration on the familiar DARZALEX schedule.”
Investors responded positively to the announcement, reflecting confidence in the therapy’s potential to reshape second‑line multiple myeloma treatment. The data will be published in the New England Journal of Medicine, underscoring the clinical significance of the findings. The combination’s success builds on recent FDA approvals for TECVAYLI (accelerated approval in October 2022) and DARZALEX FASPRO (high‑risk smoldering multiple myeloma in November 2025 and AL amyloidosis in November 2025), positioning Johnson & Johnson to capture a growing market for bispecific therapies and to expand its pipeline of next‑generation oncology products.
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