Johnson & Johnson (NYSE:JNJ) shared topline results from the investigational Phase 3 MajesTEC-9 study of Tecvayli (teclistamab-cqyv) monotherapy for multiple myeloma, a type of blood cancer.
The MajesTEC-9 study evaluates the efficacy and safety of Tecvayli versus the standard of care of pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
Phase 3 Data Show Significant Survival
MajesTEC-9 is the second Phase 3 study to support Tecvayli regimens as a potential new standard of care as early as the first relapse.
The study showed a 71% reduction in the risk of disease progression or death and a 40% reduction in the risk of death in a patient population that was predominantly refractory to anti-CD38 therapy and lenalidomide, commonly used medications in multiple myeloma.
The data confirm superior progression-free survival (PFS) and overall survival (OS) with Tecvayli compared with standard of care as early as second-line.
These results build on the MajesTEC-3 findings published in The New England Journal of Medicine, which showed significant PFS and OS benefits with Tecvayli plus Darzalex Faspro (daratumumab and hyaluronidase-fihj) in patients who were naïve or sensitive to an anti-CD38 therapy.
The safety profile of Tecvayli monotherapy was clinically manageable using established protocols and consistent with its known profile, with no new safety concerns identified.
Topline data were confirmed following this first pre-specified interim analysis. Based on the strength of the data, the Independent Data Monitoring Committee (IDMC) recommended unblinding the study.
The full results of the Phase 3 MajesTEC-9 study will be presented at a future major medical meeting and shared with global health authorities.
On Saturday, Johnson & Johnson shared new, longer follow-up results from the Phase 1b/2 OrigAMI-1 study of Rybrevant (amivantamab-vmjw) in combination with FOLFOX or FOLFIRI chemotherapy for RAS/BRAF wild-type metastatic colorectal cancer.
The company said that encouraging anti-tumor activity, durable responses, and low rates of treatment-related discontinuations observed in this study support further investigation in ongoing Phase 3 studies in first- and second-line colorectal cancer.
Price Action: JNJ stock is down 0.32% at $217.85 at the last check on Thursday.
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