On 8 December 2024, Johnson & Johnson (J&J) announced data showing that Darzalex Faspro® (daratumumab and hyaluronidase-fihj) )-based regimens improve overall and sustained minimal residual disease negativity rates and progression-free survival in patients with newly diagnosed multiple myeloma (NDMM), regardless of transplant status. The results were demonstrated in an analysis of the Phase 3 CEPHEUS study (NCT03652064) and a post hoc analysis of clinically relevant subgroups in the Phase 3 AURIGA study (NCT03901963).
On the same day, J&J also announced new frontline data featuring Tecvayli® (teclistamab-cqyv) from two investigational studies, MajesTEC-5 (NCT05695508) and MajesTEC-4 (NCT05243797).
In the MajesTEC-5 study, patients with transplant-eligible newly diagnosed multiple myeloma (NDMM) were treated with Tecvayli® in combination with Darzalex Faspro® (daratumumab and hyaluronidase-fihj), lenalidomide and dexamethasone or Darzalex Faspro®, bortezomib, lenalidomide and dexamethasone. All patients who were evaluated for MRD negativity after cycle 3 of induction therapy achieved MRD negativity (10-5) and maintained through cycle 6.
Results from the MajesTEC-4 study demonstrated the potential for Tecvayli® to be administered as a maintenance therapy following autologous stem cell transplant (ASCT).
Earlier this year, the US FDA approved J&J’s supplemental Biologics License Application (sBLA) to use Tecvayli® with a reduced dosing frequency for cancer patients (February 2024).