Phase 3 research suggests a significant leap forward in myeloma management

Sanofi’s Sarclisa, a novel treatment for multiple myeloma, has demonstrated a substantial improvement in progression-free survival for patients ineligible for transplant.

The phase 3 IMROZ study revealed that Sarclisa (also known as isatuximab), combined with a VRd regimen, reduced the risk of disease progression or death by 40% compared to VRd alone.

The study, which was presented at the American Society of Clinical Oncology (ASCO) annual meeting, marks a significant advancement in the treatment of newly diagnosed multiple myeloma (NDMM). The full data, published in the New England Journal of Medicine, will inform future regulatory submissions.

Professor Graham Jackson, a haematologist and advisor for Myeloma UK, highlighted the importance of the findings: “Effective first-line treatment is essential in managing and delaying disease progression for newly diagnosed multiple myeloma patients.

He added: “The significant progression-free survival demonstrated in the IMROZ study reinforces the potential of isatuximab-VRd to improve outcomes for newly diagnosed patients – this is wonderful news for patients and their loved ones.”

The IMROZ study is a global, randomised, multi-centre, open-label trial. At a median follow-up of 59.7 months, isatuximab-VRd showed a median progression-free survival that was not reached, compared to 54.3 months for VRd.

The estimated progression-free survival at 60 months was 63.2% for patients treated with isatuximab-VRd versus 45.2% for 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 alternatives.