ASCO: Sarclisa enhances progression-free survival with VRd in new, transplant-ineligible multiple myeloma

PARIS, France I June 3, 2024 I New data from the IMROZ phase 3 clinical trial reveal significant outcomes for Sarclisa (isatuximab) when combined with the standard treatment regimen of bortezomib, lenalidomide, and dexamethasone (VRd). This combination, followed by Sarclisa-Rd, has shown to reduce the risk of disease progression or death by 40% in patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for transplant. This landmark global study is the first to demonstrate such substantial benefits with an anti-CD38 monoclonal antibody in this patient group.

The findings were presented at the American Society of Clinical Oncology (ASCO) annual meeting and concurrently published in the New England Journal of Medicine (NEJM). Presently, the use of Sarclisa in this regimen is still investigational and under regulatory review.

Key Insights from the IMROZ Study

The IMROZ trial, an extensive, randomized, multi-center, open-label study, enrolled 446 patients across 21 countries. At the data cut-off on September 26, 2023, with a median follow-up of 59.7 months, notable differences emerged between those treated with Sarclisa-VRd and those receiving only VRd:

- Primary Endpoint: A significant improvement in progression-free survival (PFS) was observed.
- Secondary Endpoints: The combination treatment also showed enhanced complete response rates, MRD (minimal residual disease) negativity, and overall survival rates.

At the time of the data cut-off, 47.2% of patients on Sarclisa-VRd were still undergoing treatment compared to 24.3% on VRd. Sarclisa-VRd had a median treatment duration of 53.2 months, substantially longer than the 31.3 months for VRd. Safety profiles were consistent with previous data, with Grade ≥3 treatment-emergent adverse events occurring in 91.6% of the Sarclisa-VRd group and 84% of the VRd group.

Expert Opinions and Future Directions

Thierry Facon, MD, a leading hematologist and the study's principal investigator, emphasized the importance of the findings: "The significant progression-free survival benefit observed with Sarclisa combination therapy is a critical development for patients with newly diagnosed multiple myeloma. Effective frontline therapy can modify disease progression, which is crucial for transplant-ineligible patients who often face poor outcomes."

Peter C. Adamson, Global Development Head of Oncology, noted the broader implications: "For the past two decades, advancements in multiple myeloma research have accelerated, promising better outcomes. The IMROZ results underscore Sarclisa's potential in improving progression-free survival for newly diagnosed, transplant-ineligible patients."

Regulatory and Future Prospects

Following these promising results, the US Food and Drug Administration (FDA) has accepted a Priority Review application for Sarclisa in combination with VRd for transplant-ineligible NDMM patients. Similar regulatory reviews are underway in the European Union. If approved, Sarclisa could become the first anti-CD38 therapy combined with standard VRd for newly diagnosed patients not eligible for transplant, marking its third indication for multiple myeloma.

The IMROZ data will also be featured at the European Hematology Association (EHA) Annual Congress on June 15. Additional presentations at EHA will highlight results from other phase 3 studies of Sarclisa in NDMM.

About Sarclisa and Multiple Myeloma

Sarclisa, a monoclonal antibody targeting the CD38 receptor, works through mechanisms such as apoptosis and immunomodulation to induce antitumor activity. Approved in over 50 countries, it is used in combination with other treatments for relapsed refractory multiple myeloma (RRMM).

Multiple myeloma, the second most common hematologic malignancy, remains incurable despite treatment advances, with a significant percentage of patients relapsing. The ongoing development of Sarclisa aims to address these unmet needs, offering hope for improved long-term outcomes.

Sanofi continues to prioritize transformative treatments for difficult-to-treat cancers, driven by a commitment to scientific innovation and patient care.

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