Multiple Myeloma: The Dawn of a New Era in Treatment

Recent years have brought transformative breakthroughs for people battling multiple myeloma. Clinical trials and regulatory approvals are ushering in more effective treatments, hope for longer remissions, and better quality of life for both newly diagnosed and relapsed/refractory patients. 

1. Breakthroughs for Newly Diagnosed Patients 

• Quadruplet Therapies Take Center Stage: 
  The Phase 3 PERSEUS study has highlighted the power of the daratumumab-VRd regimen, where the addition of daratumumab doubled the rates of sustained minimal residual disease (MRD) negativity at 24 months and beyond, compared to standard VRd alone. Transplant-eligible patients experienced significantly better progression-free survival at four years, hinting at the possibility of long-term remission right from the start. 

2. New Hopes for Relapsed/Refractory Patients 

• CAR-T Therapies Redefine Expectations: 

- CARVYKTI® (cilta-cel): Long-term data show that a single infusion can keep 33% of heavily pre-treated patients progression-free for over five years—without further anti-myeloma therapy. 

- Anitocabtagene autoleucel (anito-cel): With a 97% overall response rate and 68% complete remission rate at 12.6 months, this next-generation CAR-T cell therapy could offer even deeper, more durable responses—especially promising for older or frailer patients if approved. 

• Dual Bispecific Antibodies Show Promise: 
  The combination of teclistamab and talquetamab, two bispecific antibodies, marks the first such pairing in oncology. Early results suggest this approach overcomes resistance and reduces relapse, especially for patients with challenging extramedullary disease (EMD). 

3. Expanding the Treatment Toolbox 

Several new therapies have recently hit the market or received expanded approvals: 

• Blenrep (belantamab mafodotin) + bortezomib/pomalidomide + dexamethasone (BVd and BPd): Now (re-)approved in Japan, the EU, and the UK, with a potential US nod expected October 23, 2025. 

• Sarclisa (isatuximab): Approved in the UK for use alongside bortezomib, lenalidomide, and dexamethasone. 

• Lynozyfic™ (linvoseltamab): Approved in the EU for relapsed/refractory cases. 

4. Innovative Treatments on the Horizon 

• CELMoD™ Agents
  
  These targeted protein degraders (like mezigdomide and iberdomide) are showing promise, especially as combination partners in hard-to-treat patients. 
  
  

Trispecific Antibodies

The pipeline is robust, including:

- NJ-79635322: Targets BCMA, GPRC5D, and CD3; showing 100% response at optimal dose with manageable safety.
- ISB 2001: Targets BCMA, CD38, and CD3; strong responses and FDA Fast Track status.
- SIM0500: Targets GPRC5D, BCMA, and CD3; promising safety and efficacy in early trials with Fast Track designation.

The fight against multiple myeloma is continuing, and radical changes are happening. With deepening remissions, new drug classes, and multidimensional immune therapies moving from trials to practice, patients have more reason than ever to hope for better outcomes and improved lives.

Contact our experts to discuss:

Siegfried Ertl, Scientific Client Lead, APLUSA

s.ertl@aplusaresearch.com

Élodie Schneider, Scientific Client Expert, APLUSA

e.schneider@aplusaresearch.com

Bertrand De Buhren, Study Director, APLUSA

b.debuhren@aplusaresearch.com