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

Johnson & Johnson (J&J) has announced significant progress in the treatment of multiple myeloma, with its combination therapy of Tecvayli and Darzalex Faspro demonstrating positive results in late-stage clinical trials. The pharmaceutical giant is now preparing to present its findings to health authorities, potentially expanding the treatment options for patients with this rare form of blood cancer.

Phase 3 Trial Success

The MajesTEC-3 trial, a late-stage study evaluating the efficacy of Tecvayli in combination with Darzalex Faspro, has met its primary endpoint of progression-free survival in patients with relapsed or refractory multiple myeloma. The trial, which included patients who had previously undergone one to three lines of therapy, also achieved 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 results, 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."

The combination therapy outperformed standard-of-care treatments, which included Darzalex Faspro with either pomalidomide and dexamethasone or bortezomib and dexamethasone. J&J reported that the safety profile of the Tecvayli-Darzalex Faspro combination was consistent with the known profiles of each drug as monotherapies.

Potential for Earlier Treatment Lines

Currently, Tecvayli, a BCMA-targeted bispecific T-cell engager, is approved by the FDA for use in patients who have tried at least four prior lines of therapy. In the European Union, the drug is cleared for use after three prior therapies. The success of the MajesTEC-3 trial could potentially lead to the approval of the Tecvayli-Darzalex Faspro combination as a second-line treatment, significantly advancing its position in the multiple myeloma treatment sequence.

This development follows promising results from the MajesTEC-5 trial, which evaluated the combination therapy in newly diagnosed, transplant-eligible multiple myeloma patients. The midstage study reported a 100% overall response rate among patients receiving the combo as their first treatment, with all evaluable patients achieving minimal residual disease negativity at the end of the induction period.

Financial Implications and Market Potential

Tecvayli has shown strong market performance since its initial FDA approval in October 2022. The drug generated $549 million in sales for 2024, representing a 39% growth over the previous year. In the third quarter of 2025, Tecvayli's sales increased by approximately 60% to $177 million compared to the same period in the previous year.

Analysts at SVB Securities have estimated that Tecvayli's peak sales could potentially exceed $2 billion. The positive results from recent clinical trials and the possibility of approval for earlier lines of treatment could further boost the drug's market potential.

As J&J prepares to present detailed data from the MajesTEC-3 trial at future medical meetings and to health authorities, the pharmaceutical industry eagerly awaits the potential impact of this combination therapy on the treatment landscape for multiple myeloma patients.