J&J Says TECVAYLI+TALVEY Cuts Risk Of Disease Progression Or Death By 89% In Multiple Myeloma Trial

Johnson & Johnson (JNJ) on Thursday reported positive topline results from the Phase 3 MonumenTAL-6 study, showing that two Tecvayli- and Talvey-based regimens significantly improved progression-free survival in adults with relapsed or refractory multiple myeloma compared with standard of care.

The study evaluated Tecvayli plus Talvey (Tec-Tal) and Talvey plus pomalidomide (Tal-P) against the investigator's choice of elotuzumab, pomalidomide and dexamethasone (EPd) or pomalidomide, bortezomib and dexamethasone (PVd) in patients who had received one to four prior lines of therapy, including an anti-CD38 antibody and lenalidomide.

Both experimental regimens met the study's primary endpoint of progression-free survival. The Tec-Tal regimen reduced the risk of disease progression or death by 89% and the risk of death by 62% versus standard of care. The Tal-P regimen reduced the risk of disease progression or death by 73%.

Johnson & Johnson said MonumenTAL-6 is the first Phase 3 trial to evaluate a dual-antigen regimen targeting both BCMA and GPRC5D in relapsed or refractory multiple myeloma.

"These findings add to a growing body of Phase 3 evidence evaluating the survival outcomes associated with the early use of immunotherapy doublets in the treatment journey," said Ajay K. Nooka, Director, Myeloma Program, Department of Hematology and Medical Oncology, Emory University School of Medicine.

Johnson & Johnson shares closed at $255.63 on Wednesday, up 2%.

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