ASCO 2024: New Hope for Newly Diagnosed Multiple Myeloma Patients

A highly effective four-drug combination could be emerging as a new standard of care for newly diagnosed myeloma patients who are not candidates (or ineligible) for stem cell transplantation. Multiple myeloma specialist Dr. Thierry Facon from Lille University Hospital and colleagues shared their findings at the ASCO 2024 conference in June.

What is the IMROZ Study for Multiple Myeloma Patients? 

The Phase 3 IMROZ study evaluated the efficacy and safety of adding isatuximab (Isa) to the standard bortezomib, lenalidomide, and dexamethasone (VRd) regimen.

The study concluded that the Isa-VRd combination significantly improved progression-free survival and response rates compared to the standard VRd regimen, offering new hope for better long-term disease management in transplant-ineligible patients.

What Are the Key Findings of the IMROZ Study? 

• There was a significant improvement in progression-free survival in patients with the Isa-VRd regimen, meaning the myeloma was controlled and less likely to cause damage over time.
• Patients treated with Isa-VRd had a 40% reduction in the risk of disease progression or death. 
• The combination had a higher rate of some adverse events, but all were manageable. 
• 55.5% of patients taking Isa-VRd achieved MRD-negative complete remission versus 40.9% with VRd. 
• 46.8% of Isa-VRd recipients sustained MRD negativity for at least 12 months, compared to 24.3% of VRd patients.

What were the Conclusions of the  IMROZ Study? 

Given the substantial benefits observed, Isa-VRd has the potential to become the new standard of care for transplant-ineligible newly diagnosed myeloma patients. 

Even though this combination had more adverse effects, it was determined to be safe to use. Patients should work closely with their healthcare team to monitor and manage any side effects.

Multiple studies continue to evaluate isatuximab, potentially expanding its application across the multiple myeloma treatment spectrum. 

The FDA is Currently Reviewing IMROZ Results to Potentially Approve a New Use for Isatuximab

On May 27, 2024, the U.S. Food and Drug Administration (FDA) accepted for Priority Review the supplemental Biologics License Application (sBLA) for the investigational use of isatuximab (Sarclisa, Sanofi) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for treating patients with transplant-ineligible newly diagnosed multiple myeloma. 

If approved, isatuximab would become the first anti-CD38 therapy used with standard-of-care VRd in this patient group, marking the third approved indication for isatuximab in multiple myeloma. The FDA's decision is expected by September 27, 2024. A similar regulatory submission is also under review in the European Union (EU).

How Can You Contribute to Research for New Medications and Combinations? 

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Sources: 

• Phase 3 study results of isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) versus VRd for transplant-ineligible patients with newly diagnosed multiple myeloma (IMROZ)
• ASCO: Sarclisa is first anti-CD38 to significantly improve progression-free survival in combination with VRd for newly diagnosed transplant-ineligible multiple myeloma in phase 3