Sanofi Gains EU Approval for Sarclisa in First-Line Treatment of Transplant-Eligible Multiple Myeloma

Sanofi Gains EU Approval for Sarclisa in First-Line Treatment of Transplant-Eligible Multiple Myeloma

(IN BRIEF) Sanofi has secured European Commission approval for Sarclisa in combination with VRd as an induction treatment for newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant. The decision was based on part one of the GMMG-HD7 phase 3 study, which demonstrated that adding Sarclisa significantly improved MRD negativity and prolonged progression-free survival compared to VRd alone. This approval marks the first global indication for Sarclisa in this patient population and means it is now authorized for use across all treatment lines in the EU, regardless of transplant eligibility. With four global approvals, including two in front-line settings, Sarclisa continues to expand its role as a key treatment in multiple myeloma care. Sanofi remains committed to advancing oncology innovation through partnerships and clinical research.

(PRESS RELEASE) PARIS, 25-Jul-2025 — /EuropaWire/ — Sanofi has announced that the European Commission has granted approval for Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as induction therapy for adult patients newly diagnosed with multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. This marks the first global regulatory endorsement of Sarclisa for transplant-eligible patients with NDMM, thereby expanding its approval in the European Union across all treatment lines and transplant eligibility categories.

The green light from EU regulators is based on compelling data from part one of the GMMG-HD7 phase 3 trial, a pivotal, two-part, randomized study conducted by the German-speaking Myeloma Multicenter Group (GMMG). The findings revealed that adding Sarclisa to VRd significantly increased the rate of minimal residual disease (MRD) negativity at the end of the 18-week induction phase—the primary endpoint of this segment of the study—and led to a statistically significant improvement in progression-free survival (PFS).

The analysis showed a deeper and more sustained therapeutic response among patients receiving the Sarclisa-VRd regimen compared to those treated with VRd alone. In particular, 53.1% of patients treated with Sarclisa-VRd maintained MRD negativity post-induction through post-transplant, compared to 38% in the control group, confirming a durable benefit that corresponded with the improved PFS outcomes.

Olivier Nataf, Global Head of Oncology at Sanofi, commented on the decision: “This approval reinforces our ambition to accelerate access to Sarclisa and provide transformative care to people living with multiple myeloma. It underscores the progress we’ve made in making this treatment available regardless of transplant eligibility or line of therapy.”

The GMMG-HD7 study enrolled 662 transplant-eligible patients across 67 sites in Germany. Participants in both study arms received three induction cycles of VRd, with Sarclisa added to one arm. Following autologous stem cell transplant, patients were re-randomized in part two to receive either lenalidomide alone or Sarclisa with lenalidomide as maintenance therapy. The second primary endpoint—PFS after the second randomization—is still pending.

Sarclisa was administered intravenously at 10 mg/kg once weekly for the first four weeks of cycle one, and then biweekly for the remainder of the induction phase. MRD was evaluated via next-generation flow cytometry with high sensitivity (1×10⁻⁵). Additional secondary endpoints included complete response rates, overall survival, and safety assessments.

With this latest indication, Sarclisa now holds four global approvals, including two in front-line settings, making it a central player in the evolving treatment landscape for multiple myeloma. It is approved across more than 50 countries, including major markets like the US, EU, Japan, and China, in various therapeutic combinations tailored to patients’ treatment history and disease stage.

In the EU and US, Sarclisa is already approved for use with VRd in transplant-ineligible NDMM patients, based on the IMROZ study. This latest EU approval for transplant-eligible patients further solidifies its front-line role. Sanofi continues to work closely with the GMMG and other research bodies to drive innovation in MM care, focusing on unmet medical needs and improved clinical outcomes.

Sanofi, an AI-powered, research-driven biopharmaceutical company, is deeply invested in developing next-generation oncology therapies. Through collaborations like the GMMG-HD7 study and ongoing clinical trials, Sanofi is pursuing science-based solutions to transform the cancer treatment paradigm.

To learn more about Sarclisa and its ongoing clinical studies, please visit www.clinicaltrials.gov.

About the GMMG-HD7 study
GMMG-HD7 is a pivotal, randomized, open-label, multicenter, two-part phase 3 study evaluating Sarclisa in combination with VRd, also referred to as RVd (lenalidomide, bortezomib, and dexamethasone), versus VRd induction followed by post-transplant re-randomization to Sarclisa plus lenalidomide versus lenalidomide maintenance alone in TE NDMM patients. The GMMG-initiated study is being conducted in close collaboration with Sanofi based on jointly defined research. Sanofi provided financial support to GMMG for this study. In December 2021, Sanofi and GMMG shared results from part one, which met the primary endpoint of MRD negativity after induction therapy and before transplant in NDMM patients.

The study enrolled 662 patients with TE NDMM across 67 sites in Germany. In the first part of the study, all participants were equally randomized to receive three 42-day induction cycles of VRd in both arms of the study, while Sarclisa was added to only one study arm. After induction treatment, all patients received intensification therapy with autologous stem cell transplant. In the second part of the study, patients were re-randomized post-transplant to receive Sarclisa plus lenalidomide or lenalidomide alone as maintenance therapy. During part one of the study, Sarclisa was administered through an intravenous infusion at a dose of 10 mg/kg once weekly for the first four weeks of cycle one, then every other week for the rest of the induction period.

The GMMG-HD7 protocol defined two primary endpoints: MRD negativity following induction therapy in the first part of the study, and PFS after the second randomization post-transplant in the second part, where Sarclisa was added to lenalidomide maintenance. The latter endpoint is expected to be available in due course. The key secondary endpoint for the first part of the study was PFS from first randomization. Additional secondary endpoints included rates of complete response after induction, and intensification, overall survival, and safety.

MRD negativity was assessed by next-generation flow cytometry (sensitivity of 1×10^-5) after induction. In the latest results, PFS for both arms, regardless of maintenance therapy, were measured from the first randomization.

About Sarclisa
Sarclisa (isatuximab) is approved in more than 50 countries, including in the US, EU, Japan, and China, across multiple lines of treatment for MM. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in the US and Japan in combination with pomalidomide and dexamethasone (Pd) for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM) who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor. Additionally, Sarclisa is approved in the EU in combination with Pd for the treatment of patients with R/R MM who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor and have relapsed on the last therapy, and in China for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Based on the IKEMA phase 3 study, Sarclisa is also approved in more than 50 countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received one to three prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy. In the US, EU, and China, Sarclisa is approved in combination with VRd as a front-line treatment option in transplant-ineligible NDMM patients, based on the IMROZ phase 3 study. Sarclisa is also approved in the EU in combination with VRd as an induction treatment for transplant-eligible NDMM patients, based on the GMMG-HD7 phase 3 study. In Japan, Sarclisa is approved in combination with VRd as a front-line treatment option regardless of transplant eligibility.

At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need.

For more information on Sarclisa clinical studies, please visit www.clinicaltrials.gov.

About the German-speaking Myeloma Multicenter Group
GMMG is the largest study group focusing on MM in Germany, with headquarters based in Heidelberg. Within the last 20+ years, the GMMG study group has performed numerous studies including five randomized, multicenter phase 3 studies with 4,000 patients enrolled from about 90 participating and cotreating centers throughout Germany. The overall goal of GMMG is to generate improved therapies for myeloma patients through the development and testing of novel and personalized, genome- and signaling driven treatment strategies. The GMMG has set itself the goal of achieving further approvals for effective antibody-based drug combinations for the first-line treatment of myeloma patients, in which antibody-based treatment regimens have been integrated into seven GMMG study concepts (CONCEPT, DANTE, DADA, HD6, HD7, HD8, HD9 and HD10).

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

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SOURCE: Sanofi