J&J's Tecvayli-Darzalex Combo Shows Promise in Multiple Myeloma Treatment

Johnson & Johnson (J&J) has made significant strides in the treatment of multiple myeloma, a rare form of blood cancer, with its combination therapy of Tecvayli and Darzalex Faspro. The pharmaceutical giant is now seeking regulatory approval for this oncology cocktail as a potential second-line treatment, following impressive results from a late-stage clinical trial.

MajesTEC-3 Trial Results

The phase 3 MajesTEC-3 trial demonstrated that the combination of Tecvayli and Darzalex Faspro outperformed standard-of-care therapy in patients with relapsed or refractory multiple myeloma who had previously undergone one to three lines of treatment. The study met its primary endpoint, showing improved progression-free survival, as well as its secondary endpoint of overall survival.

Dr. Maria-Victoria Mateos, a consultant physician in hematology from the University Hospital of Salamanca, emphasized the significance of these findings, stating, "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."

Potential for Earlier Treatment

An approval for second-line use would mark a substantial advancement for Tecvayli in the multiple myeloma treatment sequence. Currently, the FDA has only approved Tecvayli as a monotherapy for patients who have tried at least four prior lines of therapy. In contrast, the European Union allows its use after three prior therapies.

J&J's phase 3 trial compared the Tecvayli-Darzalex combination against two control treatments: Darzalex Faspro with pomalidomide and dexamethasone, or Darzalex Faspro with bortezomib and dexamethasone. The Tecvayli-based regimen demonstrated statistically significant improvements in both progression-free survival and overall survival after nearly three years of follow-up.

Promising Results in First-Line Treatment

In addition to the MajesTEC-3 trial, J&J recently reported encouraging results from the MajesTEC-5 study, which explored the potential of Tecvayli and Darzalex Faspro as a first-line treatment for newly diagnosed, transplant-eligible multiple myeloma patients. The combination therapy showed a 100% overall response rate among patients receiving it as their initial treatment.

The midstage MajesTEC-5 study involved 49 patients across three cohorts, testing regimens of Tecvayli and Darzalex Faspro with lenalidomide, both with and without bortezomib. Notably, all minimal residual disease (MRD)-evaluable patients were found to be MRD-negative at the conclusion of the trial's induction period.