TALVEY® plus DARZALEX FASPRO® with or without pomalidomide showed progression-free survival of up to 81% and overall survival of up to 89% at 24 monthsMonumenTAL-3 is the third positive study in recent months from Johnson & Johnson's ( JNJ ) bispecific portfolio and is the first Phase 3 study of a GPRC5D bispecific investigational combinationResults reinforce Johnson & Johnson's ( JNJ ) leadership in multiple myeloma, advancing bispecific combinations earlier in the treatment journey, and expanding options to match the right treatment to the right patient and stage of diseaseSTOCKHOLM, June 13, 2026 /PRNewswire/ -- Johnson & Johnson ( JNJ ) , a worldwide leader in multiple myeloma therapies, today announced results from the investigational Phase 3 MonumenTAL-3 study showing that TALVEY® (talquetamab-tgvs), a GPRC5D bispecific antibody, in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) with or without pomalidomide demonstrated significant reduction in the risk of disease progression or death of up to 72% and clinically meaningful reduction of up to 53% in the risk of death compared to the standard regimen of DARZALEX FASPRO®, pomalidomide, and dexamethasone (DPd) in patients with relapsed/refractory multiple myeloma (RRMM).1 Results showed a progression-free survival (PFS) rate of up to 81.3% versus standard of care (51.2%) and an overall survival (OS) rate of up to 89.2% versus standard of care (79.1%) at 24 months.1  

This is the first Phase 3 study to demonstrate superior PFS with a GPRC5D bispecific antibody combination in earlier-line multiple myeloma, underscoring the potential of this regimen to advance bispecific combinations earlier in the treatment paradigm.1 Results were presented at the 2026 European Hematology Association (EHA) Annual Meeting (Abstract #S100), with simultaneous publication in The New England Journal of Medicine.

Expert and company perspectives support bispecific combinations in earlier lines

"The impressive results from this study point to the promise of TALVEY plus DARZALEX FASPRO as a potential new bispecific combination for patients with relapsed or refractory multiple myeloma," said Peter Voorhees, M.D., Professor of Hematology and Oncology at Atrium Health, Levine Cancer Institute at Wake Forest University School of Medicine.* "TALVEY works with DARZALEX FASPRO in earlier lines—a critical time for treating patients with the most effective regimens."

"The MonumenTAL-3 findings underscore our commitment to bringing bispecific combinations into earlier lines of therapy, building on the strength and breadth of Johnson & Johnson's ( JNJ ) multiple myeloma portfolio," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson ( JNJ ). "These results add to our growing body of evidence across bispecific antibodies and reinforce our strategy of advancing differentiated immunotherapies to better match the right therapy to the right patient at each stage of disease."

Novel mechanism spares healthy immune cells

TALVEY ® targets a protein called GPRC5D, which is found on multiple myeloma cells (as well as some healthy cells in the body).2 GPRC5D expression is independent of other targets, including BCMA, and is absent or expressed at low levels on normal B-Cells.2 TALVEY® works by targeting myeloma cells while largely sparing healthy B-cells.2

Phase 3 MonumenTAL-3 study results

The MonumenTAL-3 study evaluated TALVEY® with DARZALEX FASPRO® (Tal-D) or TALVEY® with DARZALEX FASPRO® and pomalidomide (Tal-DP) compared to DPd in patients with RRMM who have received at least one prior line of therapy.1 At a median follow-up of two years (24.6 months), results showed significant improvement in PFS for Tal-DP (hazard ratio [HR], 0.28; 95 percent confidence interval [CI], 0.20-0.40; p