CHMP 推荐 TALVEY 联合 daratumumab 用于多发性骨髓瘤更前线治疗

Recommendation supports second-line combination option

Johnson & Johnson has announced that the CHMP recommends approval of an indication extension for TALVEY (talquetamab) plus daratumumab, with or without pomalidomide, for adults with relapsed or refractory multiple myeloma who have received at least one prior therapy.

If approved, the combination would be the only GPRC5D-targeting bispecific antibody therapy available as early as second line.

Ester in ’t Groen said: “MonumenTAL-3 demonstrated significant improvements in progression-free survival, overall survival, response rates and depth of response with the combination of talquetamab and daratumumab.”

She added: “For patients facing their first relapse, this combination has the potential to provide deep responses and keep their disease under control for longer at a critical point in their treatment journey.”

Yusri Elsayed explained: “At Johnson & Johnson, our strategy is grounded in pursuing differentiated immunotherapy approaches earlier in the disease course to address diverse patient characteristics and the evolving complexity of multiple myeloma.”

He added: “By simultaneously targeting GPRC5D and CD38, our goal is to deliver deeper and longer lasting responses for patients.”

The phase 3 MonumenTAL-3 study evaluated talquetamab plus daratumumab (Tal-D) or Tal-D and pomalidomide (Tal-DP) compared to daratumumab plus pomalidomide and dexamethasone. At a median follow-up of 24.6 months, Tal-DP achieved progression-free survival of 81.3% and Tal-D achieved 77.6%. Overall survival at 24 months reached 89.2% for Tal-DP and 87.9% for Tal-D.

Safety findings were consistent with known profiles of each monotherapy. Rates of grade 3/4 infections were lowest with Tal-D at 29.2%, followed by Tal-DP at 37.7% and DPd at 42.2%. Treatment discontinuations due to adverse events occurred in 10.5% of Tal-DP, 8.0% of Tal-D and 6.7% of DPd patients.