The European Medicines Agency Committee for Medicinal Products for Human Use has recommended an indication extension for talquetamab (TALVEY) plus daratumumab with or without pomalidomide; the recommendation covers adults with relapsed or refractory multiple myeloma who have received at least one prior therapy, according to a press release from the drug’s manufacturer, Johnson and Johnson.
The recommendation followed the phase 3 MonumenTAL-3 trial in 864 patients previously exposed to lenalidomide and a proteasome inhibitor. Compared with daratumumab, pomalidomide and dexamethasone, the talquetamab combinations significantly reduced the risk of disease progression or death, with 24-month progression-free survival rates reaching 81.3% with pomalidomide and 77.6% without pomalidomide and an overall survival rate of 89.2% versus 87.9%, respectively. Minimal residual disease-negative complete response rates reached 52.3% and 46.3% compared to 15.9% in the control arm, according to the press release.
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