CHMP Recommends Earlier-Line TALVEY Combination for Relapsed Multiple Myeloma
On October 16, 2026, the European Medicines Agency’s CHMP recommended extending TALVEY’s indication to include use with daratumumab, with or without pomalidomide, in adults with relapsed or refractory multiple myeloma after at least one prior therapy. In the phase 3 MonumenTAL-3 trial, talquetamab plus daratumumab and pomalidomide reduced the risk of progression or death by 72% versus standard therapy, while talquetamab plus daratumumab reduced it by 67%. At 24 months, progression-free survival was 81.3% and 77.6% for the two TALVEY combinations, versus 51.2% for standard therapy.
Why it matters
The recommendation supports a potential earlier-line European expansion for Johnson & Johnson’s TALVEY, but the indication still requires the relevant approval process to be completed. The trial results mechanically strengthen the product’s evidence in relapsed or refractory multiple myeloma, while grade 3/4 treatment-emergent adverse events occurred in 94.9% of the three-drug combination arm and 74.8% of the two-drug combination arm.
Key facts
- 1The CHMP recommended TALVEY with daratumumab, with or without pomalidomide, for adults with relapsed or refractory multiple myeloma who had received at least 1 prior line of therapy. onclive.com
- 2In MonumenTAL-3, talquetamab plus daratumumab and pomalidomide reduced the risk of progression or death by 72% versus daratumumab, pomalidomide and dexamethasone, while talquetamab plus daratumumab achieved a 67% reduction. onclive.com
- 3After a median follow-up of 24.6 months, 81.3% of patients receiving talquetamab plus daratumumab and pomalidomide and 77.6% receiving talquetamab plus daratumumab were alive and progression free at 24 months, compared with 51.2% receiving standard therapy. onclive.com
- 4At 24 months, overall survival was 89.2% with talquetamab plus daratumumab and pomalidomide, 87.9% with talquetamab plus daratumumab, and 79.1% with standard therapy. onclive.com
- 5The trial enrolled 864 patients who had received at least one prior line of therapy and had previously been exposed to lenalidomide and a proteasome inhibitor. marketscreener.com
Open questions
- The TALVEY plus daratumumab complete-response-or-better rate is reported as 69.0% in material 2 and 68.9% in material 3; the materials do not reconcile the difference.
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.