Al-Ola Abdallah, Associate Professor and Plasma Cell Disorder Program Director of the Division of HMCT at the University of Kansas Medical Center, shared a post on X:
“MajesTEC-3 Trial – Teclistamab + Daratumumab in RRMM
A breakthrough Phase 3 trial reshaping post-lenalidomide treatment!
Study Overview
- RRMM pts with 1–3 prior LOT, all previously exposed to PI + LEN
- Randomized 1:1 → Tec-Dara vs DPd/DVd
- n=587 across 20 countries
- BCMA-naive; CD38-refractory excluded Off-the-shelf, SC administration
Primary Endpoint ➤ PFS
Teclistamab+Dara = massive win
- HR 0.17 (83%↓ risk of progression/death)
- 36-mo PFS: 83.4% vs 29.7%
- Median PFS not reached vs 18.1 mo
Benefit consistent across subgroups
Responses and MRD
Depth matters — and this combo delivers
- ORR: 89% vs 75%
- ≥CR: 81.8% vs 32.1%
- MRD-neg 10⁻⁵: 58.4% vs 17.1%
- 36-mo response durability: 88.5% vs 36.4%
Overall Survival
Survival curves separate after early infection-related deaths
- 36-mo OS: 83.3% vs 65%
- Suggesting potential plateau in long-term survival!
Safety
Manageable but requires infection vigilance •
- CRS 60% (all grade 1-2, transient, median 2 days)
- ICANS rare (1.1%)
- Infections ↑ (G3/4: 54% vs 43%, fatal 4.6% vs 1.4%)
- Early deaths ↓ after immunoglobulin guidance update
- Neutropenia common, similar in both arms
Clinical Takeaways
- Best-in-class outcomes vs DPd/DVd
- Convenient SC monthly dosing after cycle 6
- Off-the-shelf alternative to BCMA CAR-T (may be even Better)
hopefully will see fixed duration trails and long term follow up
Infection-related early deaths are concerning; immunoglobulin use & prophylaxis protocols will determine real-world feasibility
Access and affordability will shape uptake — community centers must build infrastructure Congratulations to JNJNews on the success of this trial and to all our patients for a New Line of therapy
A new era in RRMM — survival expectations shifting!”
Title: Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma
Authors: Luciano J. Costa, Nizar J. Bahlis, Aurore Perrot, Ajay K. Nooka, Jin Lu, Charlotte Pawlyn, Roberto Mina, Gaston Caeiro, Alain Kentos, Vania Hungria, Donna Reece, Ting Niu, Anne K. Mylin, Charlotte T. Hansen, Raphael Teipel, Britta Besemer, Meletios A. Dimopoulos, Elena Zamagni, Satoshi Yoshihara, Kihyun Kim, Chang Ki Min, Paul Geerts, Elena Van Leeuwen-Segarceanu, Agata Tyczynska, Juan Luis Reguera, Magnus Johansson, Markus Hansson, Mehmet Turgut, Mark Grey, Surbhi Sidana, Paula Rodriguez-Otero, Joaquin Martinez-Lopez, Hamza Hashmi, Robin Carson, Rachel Kobos, Weili Sun, Kristen Lantz, Anne Seifert, Deborah Briseno-Toomey, Lisa O’Rourke, Maria Rubin, Diego Vieyra, Lijuan Kang, Maria Victoria Mateos
Read the full article on The New England Journal of Medicine.
More posts featuring Al-Ola Abdallah on OncoDaily.