Johnson & Johnson's BCMA/CD3 Bispecific Antibody Tecvayli Demonstrates Superiority in Second-Line Multiple Myeloma Treatment

Recently, Johnson & Johnson released a BCMA/CD3 bispecific antibody drug.Tecvayli（Teclistamab) Monotherapy Phase 3 StudyMajesTEC-9ThePositive Top-Line Results: Study results show that in the treatment of second-line (2L) multiple myeloma (MM) patients,TecvayliMonotherapy demonstrated superior progression-free survival (PFS) and overall survival (OS) compared to standard treatment.

Johnson & Johnson stated that these positive results will supportTecvayliAs a potential new standard treatment option for MM, and to share these data with global health authorities in the future.

MajesTEC-9 (NCT05572515) is a global multicenter, randomized controlled Phase III trial designed to evaluateTecvayliMonotherapy ComparisonPVd andEfficacy and Safety of Two Standard Kd Treatments in Relapsed/Refractory MM Patients with 1-3 Prior Therapies.

All enrolledMajesTEC-9's MMPatients must have previously received treatment with anti-CD38 monoclonal antibodies and lenalidomide; 85% of patients are resistant to CD38 triple antibodies, 75% are resistant to lenalidomide, and more than 90% are resistant to the last line of treatment.

Data show: randomly assigned toTecvayliPatients in the group,The risk of disease progression or death was reduced by 71%.（HR=0.29(95% CI：0.23， 0.38)），40% Reduction in Mortality Risk（HR=0.60(95% CI：0.43， 0.83)）。

TecvayliThe safety of monotherapy is clinically manageable, consistent with previously known regimens, and no new safety signals were identified.

After the first pre-specified interim analysis,The overall data has been confirmed. Based on the data intensity,The Independent Data Monitoring Committee (IDMC) recommended unblinding the study.

Johnson & Johnson Plans to Announce Phase 3 Study at Future Major Medical ConferenceMajesTEC-9The full results。

Tecvayli is a targetedThe bispecific antibody targeting BCMA/CD3 received accelerated FDA approval on October 25, 2022, for the treatment of adult patients with relapsed/refractory MM in the 4th line. In fact, Johnson & Johnson has been actively advancing its development.Tecvayli's Frontline Treatment Regimen.

Before MajesTEC-9, there was another Phase 3 study.MajesTEC-3 has provenTecvayli andThe combination regimen of DARZALEX FASPRO has the potential to becomePotential Standard Treatment for 2L in Relapsed/Refractory MM.

MajesTEC-3 study results show that, in the three-year follow-upDuring the period, the risk of disease progression or death in the combination therapy group was reduced by 83% compared to standard treatment (HR，0.17；CI，0.12-0.23;P<0.0001). 91% of patients who were progression-free at 16 months remained progression-free after 3 years.

Based on the study results, the FDA granted the Tecvayli+DARZALEX FASPRO combination regimen Breakthrough Therapy designation.

MajesTEC-3 andMajesTEC-9, Two Different Phase 3 Studies Have ProvenThe Potential of Tecvayli in Frontline Treatment of MM.

Multiple Myeloma (MM) is a type of blood cancer with a high recurrence rate. Despite the recent approval of various treatment options (including several frontline BCMA CAR-T therapies), there remains a significant unmet need for additional tolerable treatments.

Compared to the treatment costs of CAR-T cell therapy, which can easily reach hundreds of thousands of dollars,Tecvayli’s monthly treatment cost of approximately $39,000 may be more acceptable to patients and their families.

References:

1.https://www.investor.jnj.com/investor-news/news-details/2026/TECVAYLI-monotherapy-demonstrates-superior-progression-free-and-overall-survival-versus-standard-of-care-as-early-as-first-relapse-in-patients-with-multiple-myeloma-predominantly-refractory-to-anti-CD38-therapy-and-lenalidomide/default.aspx

2.https://www.biopharmadive.com/news/johnson-johnson-tecvayli-early-multiple-myeloma-majestec-results/809721/