Johnson & Johnson's MonumenTAL-6: Tecvayli+Talvey Cuts Myeloma Progression Risk 89%, Death 62%

Johnson & Johnson announced key data from the phase 3 MonumenTAL-6 clinical trial. The study evaluated the BCMA/CD3 bispecific antibody Tecvayli combined with the GPRC5D/CD3 bispecific antibody Talvey in patients with multiple myeloma who had received two to five prior lines of therapy. The data showed that the combination therapy reduced the risk of disease progression or death by 89% and the risk of death by 62% compared with standard therapy. The first interim analysis achieved statistically significant benefits on both the progression-free survival and overall survival endpoints.

In a non-head-to-head comparison, the BCMA CAR-T product Carvykti, in the Cartitude-4 study, reduced the risk of disease progression by 71% and the risk of death by 45% compared with conventional standard therapy for patients with second-line or later multiple myeloma. In March, Tecvayli in combination with the anti-CD38 antibody daratumumab was approved for relapsed/refractory multiple myeloma; the phase 3 MajesTEC-3 study showed a 83% reduction in the risk of disease progression or death. The MonumenTAL-6 study enrolled patients who had previously received a CD38 antibody, and about 80% of those patients were resistant to daratumumab.

The Cartitude-4 and MonumenTAL-6 trials are not strict head-to-head studies. Cartitude-4 required patients to be resistant to lenalidomide, while MonumenTAL-6 only required that patients had previously received lenalidomide. Cartitude-4 also included patients who had not been treated with daratumumab as well as those who had received the drug. Talvey targets GPRC5D×CD3 and has been shown to be effective for patients whose disease progressed after BCMA-targeted therapy. Cartitude-4 trial data showed that about 50% of high-risk patients and 30% of standard-risk patients who received prior therapy experienced disease progression within three years.