Johnson & Johnson’s EMA Application for Teclistamab Daratumumab Therapy: A New Hope for Myeloma Patients

Wondering how teclistamab daratumumab therapy could change treatment options for relapsed/refractory multiple myeloma? Johnson & Johnson recently filed a Type II variation application with the European Medicines Agency (EMA), which seeks to expand TECVAYLI® (teclistamab) combined with DARZALEX® subcutaneous (daratumumab SC) for adults after just one prior therapy. This bispecific antibody and monoclonal antibody duo targets BCMA and CD38 proteins while boosting immune responses earlier, potentially improving outcomes in second-line care. Backed by strong Phase 3 data, it shows big cuts in disease progression and death risks.

Teclistamab daratumumab therapy offers a key advance in relapsed/refractory multiple myeloma, as Johnson & Johnson’s EMA submission aims to broaden its use beyond heavy pretreatment. The Phase 3 MajesTEC-3 study drives this effort, having found an 83.4% lower risk of progression or death versus standard care, with benefits that include better progression-free survival and overall survival. This ready-to-use immunotherapy enhances immune attacks on myeloma cells, and it pairs well with current treatments.

MajesTEC-3 Trial Results and Efficacy Highlights

Teclistamab daratumumab therapy pioneers a bispecific approach, as teclistamab links T-cells to BCMA on cancer cells via CD3 while daratumumab SC blocks CD38 to curb tumor growth. MajesTEC-3 trial results highlight its strengths:

• Efficacy Boost: 83.4% reduced risk of progression or death (HR 0.17; 95% CI 0.12-0.23; P<0.0001) after nearly three years, during which over 90% progression-free at six months stayed so at three years.
• Survival Benefits: Clear gains in progression-free survival (main goal) and overall survival, positioning it as a leader in early relapsed settings.
• Safety Notes: Grade 3/4 side effects similar (95.1% vs. 96.6%), with common issues including cytopenias and infections, though any-grade infections hit 96.5% and early use aids immune health.
• Trial Setup: Randomized 587 patients with 1-3 prior lines and compared the combo to daratumumab SC plus dexamethasone with pomalidomide or bortezomib.

These findings appeared at the 2025 ASH Annual Meeting and in The New England Journal of Medicine, proposing blending bispecific and monoclonal antibodies that target deeper remissions in multiple myeloma management.

Multiple Myeloma Overview and Trial Foundations

Multiple myeloma is a plasma cell cancer in bone marrow that causes bone damage, infections, and fatigue, with relapses shortening over time. In the EU, 2022 saw over 35,000 new cases and 22,700 deaths, making new regimens vital.

The MajesTEC-3 study (NCT05083169) supports this EMA filing as an ongoing Phase 3 trial that enrolled 587 adults post 1-3 therapies. Groups included teclistamab plus daratumumab SC (n=291) versus standard combo (n=296), with a focus on progression-free survival along with others like response rates, minimal residual disease (10⁻⁵ sensitivity), survival, symptoms, and safety.

Teclistamab got EU approval in August 2022 for three-plus prior lines as a subcutaneous bispecific antibody that sparks T-cells against BCMA cells. Daratumumab SC targets CD38 with rHuPH20 for quick shots and has helped over 618,000 patients worldwide across ten Phase 3 trials.

For more on the EMA application and MajesTEC-3, explore Johnson & Johnson’s official press release. This builds on teclistamab’s 2023 dosing tweaks and shows therapy sequencing.

Future Impact on Care, Costs, and Research

How will teclistamab daratumumab therapy affect multiple myeloma care and costs? Early second-line use could cut advanced relapse burdens by reducing hospital stays for infections or bone problems, while deeper remissions mean longer progression-free times. This may lower EU costs, where myeloma treatment tops billions yearly, and its safety matches standards to fit value-based care, beating complex CAR-T with easy access.

In research, it bolsters immunotherapy plans by targeting BCMA and CD38 to keep immunity strong longer. It could shape EMA guidelines and U.S. FDA paths (with Breakthrough Therapy status). Real-world data may track minimal residual disease and quality of life, and if approved, it expands high-efficacy access to boost survival fairness and fit wider myeloma strategies.

FAQ

What makes teclistamab daratumumab therapy effective against multiple myeloma?
It hits BCMA and CD38 on cancer cells, as teclistamab draws T-cells for attack while daratumumab SC blocks tumor growth, creating a dual hit that amps immune destruction for better control.

How does the MajesTEC-3 study prove teclistamab daratumumab therapy’s value?
The trial cut progression or death risk by 83.4% over standard care and showed solid progression-free and overall survival gains, with results that led to top journal publication.

When might teclistamab daratumumab therapy reach second-line use in Europe?
The Type II filing targets therapy expansion, though EMA reviews take months, and U.S. Breakthrough status hints at faster approval if data stands.