Johnson & Johnson’s Talvey combination moved closer to earlier use in multiple myeloma on October 16, 2026, when the European Medicines Agency’s medicines committee recommended expanding its indication. The recommendation covers talquetamab, marketed as Talvey, plus daratumumab, with or without pomalidomide, for adults with relapsed or refractory disease after at least one prior therapy. It is not a final European Commission approval.
Key Takeaways
- The recommendation would allow the combination as early as second-line treatment if approved.
- Both talquetamab combinations improved disease-control and survival outcomes against the trial’s comparator regimen.
- Serious adverse events remained frequent, with safety outcomes varying between the two combinations.
Table of Contents
- Talvey combination could move into second-line treatment
- Phase 3 trial supports earlier use
- Safety results differ between the combinations
- Conclusion
Talvey combination could move into second-line treatment
The recommended indication extension would move Talvey into a substantially earlier treatment setting. Its August 2023 conditional EU authorization covered use alone in adults who had received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose disease had progressed on their last therapy.
The proposed combination instead covers patients after at least one prior therapy, including those facing their first relapse. For Johnson & Johnson, the regulatory milestone advances its stated strategy of using its multiple myeloma medicines earlier in the disease course; it does not yet establish a broader authorized market.
Talquetamab engages T-cells and targets GPRC5D, a protein found on myeloma cells and some healthy cells. Daratumumab targets CD38. The combination therefore brings together two different approaches to attacking myeloma cells.
| Item | Details |
|---|---|
| Tal-DP: talquetamab, daratumumab and pomalidomide | Overall response rate: 88.2%; complete response or better: 71.1%. |
| Tal-D: talquetamab and daratumumab | Overall response rate: 88.5%; complete response or better: 68.9%. |
| DPd: daratumumab, pomalidomide and dexamethasone | Overall response rate: 77.6%; complete response or better: 34.5%. |
Phase 3 trial supports earlier use
The recommendation was supported by MonumenTAL-3, an ongoing Phase 3 study involving 864 participants. It compared talquetamab plus daratumumab, called Tal-D, and the same combination with pomalidomide, called Tal-DP, against daratumumab, pomalidomide and dexamethasone, called DPd.
All participants had previously received lenalidomide and a proteasome inhibitor. Most had disease refractory to lenalidomide, at 85.1%, and to their last treatment, at 93.4%. Median follow-up was 24.6 months.
At 24 months, progression-free survival—the proportion alive without disease progression—was 81.3% with Tal-DP and 77.6% with Tal-D. Johnson & Johnson reported statistically significant improvements over DPd for both combinations.
Overall survival at 24 months was 89.2% with Tal-DP and 87.9% with Tal-D. The overall-survival hazard ratios versus DPd were 0.47 and 0.51, respectively. Both combinations also produced higher response rates and more complete responses than the comparator.
Safety results differ between the combinations
Grade 3 or 4 treatment-emergent adverse events occurred in 94.9% of patients receiving Tal-DP, 74.8% receiving Tal-D and 91.5% receiving DPd. Johnson & Johnson said the overall safety profiles were consistent with those known for the individual medicines.
Grade 3 or 4 infections occurred in 37.7%, 29.2% and 42.2% of patients, respectively. Thus, Tal-D had the lowest rate of severe infections, although infections of any grade affected more than four-fifths of patients in every group.
Fatal adverse events occurred in 1.8% of the Tal-DP group, 4.0% of the Tal-D group and 4.6% of the DPd group. Treatment discontinuations because of adverse events were 10.5%, 8.0% and 6.7%, respectively. These findings show that improved efficacy did not eliminate substantial treatment risks.
Conclusion
The next regulatory milestone is a European Commission decision on the proposed extension. Until then, the CHMP recommendation supports—but does not authorize—use of the Talvey combination in this earlier treatment setting.
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