FDA Grants Priority Review to Sarclisa Combo for Patients with Newly Diagnosed Multiple Myeloma Based on IMROZ Trial Findings
Sarclisa (isatuximab-irfc) could become the first anti-CD38 therapy indicated in combination with bortezomib, lenalidomide, and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for a transplant.
Image credit: LASZLO | stock.adobe.com
Positive findings from the Phase III IMROZ clinical trial led to the FDA granting Priority Review to a supplemental Biologics License Application (sBLA) from Sanofi for Sarclisa (isatuximab-irfc) combined with bortezomib, lenalidomide, and dexamethasone (VRd) to treat transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM).1
Sarclisa is a targeted monoclonal antibody with two previous approvals for patients with relapsed and refractory multiple myeloma, which is the second most common type of blood cancer.2,3 Should the FDA approve the latest sBLA for Sarclisa, it would become the first anti-CD38 therapy indicated in combination with VRd for newly diagnosed patients who are ineligible for a transplant.
“Despite recent advancements in multiple myeloma treatment, there remains a significant unmet need for new frontline therapies, particularly for transplant-ineligible patients who can face poor outcomes from the disease,” Dietmar Berger, MD, PhD, chief medical officer, global head of Development at Sanofi, said in a press release. “The filing acceptances, as well as the FDA’s Priority Review designation, reinforce our confidence in Sarclisa as a potential best-in-class treatment and represent a critical step toward advancing this combination in a difficult-to-treat cancer.”1
The randomized, multi-center, open label IMROZ trial enrolled 484 transplant-ineligible patients with NDMM across 21 countries. Patients in the treatment cohort were administered Sarclisa via intravenous (IV) infusion at a dose of 10 mg/kg once weekly for five weeks through the first 42-day cycle and once every two weeks in cycles two to four combined with subcutaneous bortezomib, oral lenalidomide, and IV or oral dexamethasone. Sarclisa was then administered every two weeks from cycle five to 17 and every four weeks in cycles 18-plus during 28-day cycles combined with standard doses of lenalidomide and dexamethasone until disease progression, unacceptable safety, or patient decision to cease treatment.4
The trial’s primary endpoint is progression-free survival (PFS), with key secondary endpoints that include complete response rate; minimal residual disease (MRD) negativity rate for patients who achieved a complete response, very good partial response, or better rate; overall survival; overall response rate; time to progression; duration of response; time to first response; time to best response; PFS on next line of therapy; PFS 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.
The trial found that the Sarclisa combination achieved a statistically significant improvement in PFS compared with VRd alone in transplant-ineligible patients with NDMM. In terms of safety, the tolerability profile was consistent with prior findings regarding Sarclisa and VRd, with no new safety signals identified.4
“The IMROZ trial outcome is promising for patients with newly diagnosed multiple myeloma who are transplant-ineligible, as there remains a significant unmet need for potential new therapies,” IMROZ principal investigator Thierry Facon, MD, said in a press release. “First-line therapeutic options are critical for all patients, but especially for those who are transplant-ineligible, given attrition rates in subsequent lines of therapy.”4
IMROZ was the fourth Phase III trial of Sarclisa combinations in patients with NDMM that showed superiority compared with standard of care, which bolsters its potential as a best-in-class therapy, according to Sanofi. Data from the IMROZ trial will be featured in an oral presentation at the 2024 American Society of Clinical Oncology Annual Meeting and at the 2024 European Hematology Association Annual Congress.
The FDA assigned the sBLA for the combination with a Prescription Drug User Fee Act Date of September 27, 2024.1
References
1. Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma. News release. Sanofi. May 27, 2024. Accessed May 29, 2024.
2. FDA approves Sarclisa (isatuximab-irfc) for patients with relapsed multiple myeloma. News release. Sanofi-aventis U.S. LLC. March 2, 2020. Accessed May 29, 2024. https://www.sanofi.com/en/media-room/press-releases/2020/2020-03-02-19-51-16
3. Understanding SARCLISA. International Myeloma Foundation. Published June 2020. Accessed May 29, 2024. https://imf-d8-prod.s3.us-west-1.wasabisys.com/2020-06/U-Sarclisa.pdf
4. Sarclisa® (isatuximab) Phase 3 trial met primary endpoint of progression free survival in patients with newly diagnosed multiple myeloma not eligible for transplant. News release. Sanofi. December 7, 2023. Accessed May 29, 2024. https://www.sanofi.com/en/media-room/press-releases/2023/2023-12-07-06-35-00-2792221
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
