J&J builds case for earlier Tecvayli use in multiple myeloma

Johnson & Johnson has added another piece to the data behind its effort to move Tecvayli into earlier-line therapy for multiple myeloma, including the first relapse setting.

In the MajesTEC-9 trial, monotherapy with the BCMAxCD3 bispecific T-cell engager in patients whose disease had progressed despite one to three lines of prior treatment reduced the risk of death by 40% compared to other standard regimens.

That overall survival (OS) result was accompanied by a 71% reduction in progression-free survival with Tecvayli (teclistamab) compared to either pomalidomide-bortezomib-dexamethasone (PVd) or carfilzomib-dexamethasone (Kd) in the subjects, who had all been previously treated with J&J and Genmab's anti-CD38 therapy Darzalex Faspro (daratumumab) and lenalidomide.

The data monitoring committee has recommended unblinding the trial based on the strong efficacy signal.

The monotherapy data follows earlier results from the MajesTEC-3 study, reported at last year's ASH congress, which also showed significant improvements in OS and PFS – improved by 54% and for the combination of Tecvayli and Darzalex Faspro among patients previously treated with one to three prior lines of therapy, prompting J&J to start talking about achieving a 'functional cure' with the regimen and "resetting" survival expectations.

There was an imbalance between the treatment and control groups on safety, notably an increase with Tecvayli/Darzalex in fatal infections, which will need to be monitored. J&J did not provide any safety data in its update on MajesTEC-9, but said the data will be reported in full at a future major medical meeting.

MajesTEC-3 and MajesTEC-9 will be used by J&J to file for approval of Tecvayli in second-line or later treatment of multiple myeloma, allowing the drug to address a much larger patient population, and "address the continuum of unmet need" in the blood cancer, said J&J. The bispecific is currently approved in the US as a fifth-line or later therapy and as a fourth-line treatment in the EU.

Last month, the MajesTEC-3 study results earned Tecvayli a Commissioner's National Priority Voucher (CNPV), which could deliver approval for a marketing application in just a few weeks.

J&J has said that Tecvayli has the potential to grow into a $5 billion-a-year product if its label is expanded to include earlier-line use. In the first nine months of 2025, worldwide sales grew more than 22% to $494 million.

Yusri Elsayed, J&J's head of oncology R&D, said the data, alongside other therapies in the company's multiple myeloma portfolio, are "bringing us another step closer to cure."

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