Phase 3 study suggests major advance in myeloma treatment
Sanofi’s Sarclisa, a new treatment for multiple myeloma, has demonstrated a significant improvement in progression-free survival in patients who cannot undergo transplant.
The Phase 3 IMROZ trial found that combining Sarclisa (also known as isatuximab) with VRd therapy reduced the risk of disease progression or death by 40% compared with VRd alone.
The study, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, represents a major advance in the treatment of newly diagnosed multiple myeloma (NDMM). New England Journal of Medicinewill be reflected in future regulatory filings.
Professor Graham Jackson, haematologist and consultant to the British Myeloma Society, highlighted the importance of the findings: “Effective first-line treatment is essential to manage patients with newly diagnosed multiple myeloma and slow the progression of the disease.”
He added: “The significant progression-free survival demonstrated in the IMROZ study supports the potential of isatuximab-VRd to improve outcomes for newly diagnosed patients, which is great news for patients and their families.”
The IMROZ study is an international, randomized, multicenter, open-label study. With a median follow-up of 59.7 months, median progression-free survival was not reached in isatuximab VRd compared with 54.3 months in VRd.
Estimated progression-free survival at 60 months was 63.2% in patients treated with isatuximab-VRd compared with 45.2% in patients treated with VRd.
This investigational use of isatuximab in combination with VRd for transplant-ineligible NDMM patients has not yet been fully evaluated by regulatory authorities.
However, the IMROZ study provides a clear clinical proof of concept, offering hope for improved treatment options in a patient population with limited options.
