According to Johnson & Johnson, results of the Phase 3 MajesTEC-3 study reveal TECVAYLI® plus DARZALEX FASPRO® combination significantly improves PFS and overall survival.

On Thursday, October 16, Johnson & Johnson announced “positive topline results from the investigational Phase 3 MajesTEC-3 study” via a press release.

“The study evaluates the efficacy and safety of TECVAYLI® (teclistamab-cqyv) in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) versus investigator’s choice of DARZALEX FASPRO, pomalidomide, and dexamethasone (DPd) or DARZALEX FASPRO, bortezomib, and dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma (RRMM) who received one to three prior lines of therapy,” states Johnson & Johnson.

At follow-up after almost three years, treatment with TECVAYLI and DARZALEX FASPRO showed significant delayed progression of multiple myeloma compared to standard treatments. Early results also showed a meaningful improvement in overall survival.

Because of these statistically significant results, the Independent Data Monitoring Committee (IDMC) has recommended “unblinding the study.”

IMF Scientific Advisory Member and Consultant Physician in Hematology at the University Hospital of Salamanca in Spain Maria-Victoria Mateos, M.D., Ph.D., said: “TECVAYLI is the most utilized BCMA bispecific in later lines of myeloma treatment, supported by extensive clinical and real-world evidence. These results demonstrate the clinical benefits of TECVAYLI in earlier lines when used in combination, as evidenced by meaningful progression-free survival and overall survival outcomes. TECVAYLI and DARZALEX FASPRO uniquely work together to target both BCMA and CD38 simultaneously, priming and activating the immune system and eliminating myeloma cells.”

Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine Yusri Elsayed, M.D., M.H.Sc., Ph.D., said: “The MajesTEC-3 study results of TECVAYLI plus DARZALEX FASPRO, two of our most important agents, demonstrate Johnson & Johnson’s leadership in developing regimens with complementary and synergistic mechanisms of action for patients with multiple myeloma. We are confident this combination is poised to be a new standard of care option. The increase in progression-free survival and overall survival is another example of how our portfolio is fundamentally transforming how patients with multiple myeloma are treated.”

“The overall safety profile of TECVAYLI administered in combination with DARZALEX FASPRO was consistent with the known safety profiles of each monotherapy,” further states the press release.

To know more, read the full press release.