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# J&J Reports Positive Data From Multiple Myeloma Study
- URL: https://www.fdaweb.com/j-j-reports-positive-data-from-multiple-myeloma-study/
- Published: 2026-07-23T12:00:00.000Z
- Updated: 2026-09-14T13:43:36.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5161512

Johnson & Johnson is reporting positive topline results from the three-arm investigational Phase 3 MonumenTAL-6 study evaluating Tecvayli (teclistamab-cqyv) plus Talvey (talquetamab-tgvs), a BCMA and GPRC5D dual antigen targeting regimen, and Talvey plus pomalidomide in adult patients with relapsed or refractory multiple myeloma (RRMM) who received one to four prior lines of therapy, including an anti-CD38 antibody and lenalidomide.

The company says the study “demonstrated statistically significant and clinically meaningful improvements in progression-free survival and overall survival for both investigational arms compared with investigator’s choice standard of care. Tecvayli plus Talvey delivered the greatest benefit, reducing the risk of disease progression or death by 89% (HR, 0.11) and the risk of death by 62% (HR, 0.38). This represents the lowest hazard ratio seen across any Phase 3 study evaluating bispecific therapies in relapsed/refractory multiple myeloma.

Based on the data, the Independent Data Monitoring Committee recommended unblinding the study at the first interim analysis. The full results will be presented at a future major medical meeting and shared with global health authorities, according to the company.