MHRA grant approval of SARCLISA (isatuximab) as the first and only anti-CD38 quadruplet therapy to treat transplant-ineligible newly diagnosed multiple myeloma adult patients

• Regulatory approval is based on positive results from the IMROZ phase 3 study, demonstrating isatuximab in combination with VRd significantly improved Progression-Free Survival (PFS), compared to the current combination of VRd in transplant ineligible newly diagnosed multiple myeloma (TI NDMM)
• Isatuximab is now licensed in the UK as an anti-CD38 quadruplet therapy for transplant-ineligible adults newly diagnosed with multiple myeloma

Reading, 28 January, 2025

Following European Commission a few days ago, the Medicines and Healthcare product Regulatory Agency (MHRA) has approved isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplant (ASCT), based on data from the IMROZ phase 3 study.

Anju Bhalla

Head of Oncology and Haematology at Sanofi UK and Ireland

“While significant strides have been made in multiple myeloma treatment there is a continued unmet need for patients with multiple myeloma. Effective first-line treatment is essential in managing and delaying disease progression for newly diagnosed transplant ineligible multiple myeloma patients. With today’s decision, patients across the UK are a step closer to accessing a new combination therapy. This marks a crucial milestone in our commitment to advancing multiple myeloma treatment and improving patient outcomes in the United Kingdom.”

About the IMROZ study

The randomised, multi-centre, open-label IMROZ phase 3 clinical study enrolled 446 patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for transplant across 21 countries and 104 centers. During the study, isatuximab was administered through an intravenous infusion at a dose of 10 mg/kg once weekly for five weeks during first 42-day cycle and once every two weeks in cycles 2 to 4 in combination with subcutaneous bortezomib, oral lenalidomide and intravenous or oral dexamethasone. Then isatuximab was administered every 2 weeks from cycle 5 to 17 and every 4 weeks in cycles 18+ during 28-day cycles in combination with lenalidomide and dexamethasone at the standard dose, until disease progression, unacceptable side effects or patient’s decision to stop the study treatment.

The primary endpoint was progression-free survival (PFS). Key secondary endpoints include complete response rate, MRD negativity rate for patients with a complete response, very good partial response or better rate, overall survival. Other secondary endpoints were: overall response rate, time to progression, duration of response, time to first response, time to best response, progression-free survival on next line of therapy, progression-free survival by MRD status, sustained MRD negativity greater than or equal to 12 months rate, safety, pharmacokinetic profile, immunogenicity, disease-specific and generic health-related quality of life, disease and treatment-related symptoms, health state utility, and health status. ¹

 The safety and tolerability of isatuximab-VRd observed in this study was consistent with the known safety profile of each agent, with no new safety signals observed. The incidence of serious adverse events during treatment (70.7% IsaVRd vs. 67.4% VRd) and adverse events leading to discontinuation (22.8% IsaVRd vs. 26.0% VRd), were similar in the two groups.

 About isatuximab

Isatuximab is a CD38 monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a target for antibody-based therapeutics such as isatuximab.

In September 2024, the US Food and Drug Administration (FDA) approved isatuximab in combination with VRd for the treatment of adult patients with NDMM ineligible for ASCT, representing the first global approval for isatuximab in the front-line setting. Beyond the US, China and the EU, regulatory submissions for isatuximab in NDMM ineligible for ASCT are under review in Japan.

About multiple myeloma

Multiple myeloma is a progressive, incurable cancer of the blood plasma cells. ² It affects around 24,000 individuals in the UK at any one time.² There are an estimated 5,900 new cases of multiple myeloma in the UK every year, equivalent to 16 people being diagnosed each day.²  Treatments become limited as patients continue to relapse, as such ensuring as many options are available at each line of therapy is vitally important.² Targeted combinations are standard-of-care in multiple myeloma and have driven recent progress. ³

About Sanofi

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Sanofi in Oncology

In striving to become the number one immunoscience company globally, Sanofi remains committed to advancing oncology innovation. Through focused strategic decisions the company has reshaped and prioritised its pipeline, leveraging its expertise in immunoscience to drive progress. Efforts are centered on difficult-to-treat often rare cancers such as select haematologic malignancies and solid tumours with critical unmet needs, including multiple myeloma, acute myeloid leukaemia, certain types of lymphomas, as well as gastrointestinal and lung cancers.

Media Relations

Quiterie Mertian, Communications Manager, Specialty Care, Sanofi UK & Ireland  

+44 (0) 7740 935 217| quiterie.mertian@sanofi.com 

Simon Butler, Corporate Affairs Lead, Specialty Care, Sanofi UK & Ireland  

+44 (0)7921 054 943| Simon.Butler@sanofi.com 

Sanofi forward-looking statements

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References

[1] ClinicalTrials.gov.Identifier#NCT03319667. https://clinicaltrials.gov/ct2/show/NCT03319667. Last accessed: January 2025

² Myeloma UK. What is myeloma? Available at: https://www.myeloma.org.uk/understanding-myeloma/what-is-myeloma/. Last accessed: January 2025

³ Myeloma UK. Treatment for relapsed myeloma. Available at: https://www.myeloma.org.uk/understanding-myeloma/treating-myeloma/treatment-for-relapsed-myeloma/. Last accessed: January 2025