CHMP backs TALVEY plus daratumumab for earlier-line relapsed or refractory multiple myeloma

Johnson & Johnson has received a positive recommendation from the Committee for Medicinal Products for Human Use for an expanded indication of TALVEY, also known as talquetamab, in relapsed or refractory multiple myeloma.

The recommendation covers talquetamab in combination with daratumumab, with or without pomalidomide, for adults who have received at least one previous line of therapy.

If approved by the European Commission, the combination would allow TALVEY-based treatment to move into an earlier stage of relapsed or refractory disease, including from the second-line setting.

Johnson & Johnson said the regimen would also become the only GPRC5D-targeting bispecific antibody combination available for patients with relapsed or refractory multiple myeloma this early in the treatment pathway.

The CHMP opinion is supported by results from the Phase III MonumenTAL-3 study.

The trial compared talquetamab plus daratumumab, known as Tal-D, and talquetamab plus daratumumab and pomalidomide, known as Tal-DP, with daratumumab, pomalidomide and dexamethasone.

A total of 864 patients were enrolled.

All participants had previously been exposed to lenalidomide and a proteasome inhibitor and had received at least one prior line of treatment.

At a median follow-up of 24.6 months, both TALVEY-based regimens significantly improved progression-free survival compared with the control arm.

Tal-DP produced a hazard ratio of 0.28, while Tal-D achieved a hazard ratio of 0.33.

At 24 months, progression-free survival was 81.3% with Tal-DP and 77.6% with Tal-D.

Overall survival was also improved.

At 24 months, the overall survival rate reached 89.2% with Tal-DP and 87.9% with Tal-D.

Both TALVEY combinations also produced significantly higher response rates than daratumumab, pomalidomide and dexamethasone.

Overall response rates were 88.2% with Tal-DP and 88.5% with Tal-D, compared with 77.6% in the control group.

Complete response or better was achieved by 71.1% and 68.9% of patients receiving the TALVEY combinations respectively, compared with 34.5% with the comparator regimen.

Minimal residual disease negative complete response or better was achieved by 52.3% with Tal-DP and 46.3% with Tal-D, compared with 15.9% in the control group.

Ester in ’t Groen, EMEA Therapeutic Area Head for Haematology at Johnson & Johnson, said the findings support the potential for talquetamab-based combinations to achieve deeper responses and prolong disease control earlier in the treatment pathway.

Yusri Elsayed, MD, MHSc, PhD, Global Therapeutic Area Head of Oncology at Johnson & Johnson, said combining talquetamab with daratumumab brings together complementary mechanisms targeting GPRC5D and CD38.

Talquetamab targets GPRC5D, a protein expressed on multiple myeloma cells, while daratumumab targets CD38.

Johnson & Johnson said the different targets allow the combination to attack myeloma cells through complementary immune mechanisms.

The CHMP recommendation will now be reviewed by the European Commission before a final decision on the expanded indication is made.

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Related Topics and Keywords

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