On Thursday, Johnson & Johnson (NYSE:JNJ) announced positive topline results from a recent study.
The company’s Phase 3 MajesTEC-3 trial is evaluating Tecvayli (teclistamab-cqyv) in combination with Darzalex Faspro (daratumumab and hyaluronidase-fihj) for patients with relapsed or refractory multiple myeloma who received one to three prior treatments.
After nearly three years of follow-up, the Tecvayli-Darzalex combination significantly improved both progression-free survival (PFS) and overall survival (OS) compared to current standard therapies. The Independent Data Monitoring Committee has recommended unblinding the study based on these strong results. Safety profiles were consistent with known data for each drug individually.
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J&J highlighted that MajesTEC-3 is the first Phase 3 study to show this combination outperforms standard care in both PFS and OS. Full results will be presented at an upcoming medical meeting and shared with regulators.
Earlier Phase 2 data (MajesTEC-5) also showed promising results, with a 100% overall response rate and all evaluable patients achieving minimal residual disease negativity in newly diagnosed, transplant-eligible patients.
Tecvayli, approved by the FDA in 2022 for heavily pretreated multiple myeloma patients, received expanded approval in 2024 for reduced dosing frequency in those maintaining complete response for at least six months.
Price Action: JNJ stock is up 0.50% at $192.12 at the last check on Thursday.
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