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Today (January 9),Sanofi just announcedIsatuximab InjectionThe listing application has been approved.National Medical Products Administration (NMPA)Approval.Isatuximab (isatuximab, trade name: Sarclisa) is aNovel CD38-targeted monoclonal antibody. This approvalUsed in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (including lenalidomide and proteasome inhibitors).
This approval is based on the results of the global Phase 3 ICARIA-MM study and the Chinese IsaFiRsT real-world study. The ICARIA-MM study showed that the combination therapy of Isatuximab Injection and Pd (Isa-Pd)Significantly reduce the risk of disease progression or death by 40%, extend progression-free survival (PFS) nearly twofold, and prolong overall survival (OS), demonstrating clinically meaningful survival benefits.Real-world study IsaFiRsT conducted in China showsThe Overall Response Rate (ORR) in Chinese patients with relapsed or refractory multiple myeloma reached 82.6%.。
Multiple Myeloma (MM) is the second most common malignant tumor in the hematologic system, with a high incidence in people over 60 years old. Despite available treatments, MM remains an incurable malignant tumor, imposing a significant burden on patients. As MM cannot be cured, most patients will relapse, and those with late-stage recurrence often face the dilemma of "lack of treatment options in later lines."CD38 is highly expressed on the surface of multiple myeloma cells and is a potential receptor target on the cell surface.Isatuximab is a monoclonal antibody that targets a specific epitope of the CD38 receptor on multiple myeloma cells. This product can trigger multiple different mechanisms of action, including programmed tumor cell death (apoptosis) and modulation of the body's immune response.In March 2020, Isatuximab was approved by the U.S. FDAApprovalIn combination with pomalidomide and dexamethasone, it is used to treat adult MM patients who have received at least two prior therapies. In April 2021, Isatuximab was approved by the FDA.ApprovalIn combination with the standard treatment of carfilzomib and dexamethasone (Kd), it is used to treat patients with relapsed/refractory multiple myeloma (R/R MM) who have received 1-3 prior therapies. Previously, Isatuximab was also approved for early introduction at The University of Hong Kong Shenzhen Hospital for the above two indications of multiple myeloma.According to a previous press release by Sanofi, Isatuximab can bring clinically meaningful benefits to patients with various types of MM:- Data from the Phase 3 ICARIA-MM study show that, compared with the standard treatment regimen (pomalidomide-dexamethasone), isatuximab in combination with pomalidomide and dexamethasoneSignificantly prolongs the progression-free survival (median PFS: 11.53 months vs 6.47 months) and significantly increases the overall response rate (ORR: 60.4% vs 35.3%) in MM patients.；
- Global Phase 3 clinical IKEMA study results show that, compared withCarfilzomib and Dexamethasone (Kd)Compared with the treatment group, the median PFS of patients in the combination regimen group of isatuximab and Kd reached 35.7 months.`, reducing the risk of recurrence and mortality by 42%`; while significantly improving the depth of response in R/R MM patients (≥complete response rate 44.1%);
- Data from the Phase 3 IMROZ study indicate that isatuximab in combination with the standard treatment regimen of bortezomib, lenalidomide, and dexamethasone (VRd), followed by isatuximab in combination with lenalidomide and dexamethasone (Rd) for subsequent treatment,Reduced the risk of disease progression or death by 40% in newly diagnosed multiple myeloma patients ineligible for hematopoietic stem cell transplantation.；
- Results from the Phase 3 IsKia study showed that the addition of isatuximab to carfilzomib, lenalidomide, and dexamethasone (KRd) treatmentNewly Diagnosed MM Patients Suitable for Transplant，77% achieved minimal residual disease (MRD) negativity after consolidation therapy.。
Public information shows that Sanofi is also in developmentSubcutaneous Injection of Isatuximab. An international multicenter Phase 3 clinical study is being conducted in China, aiming to compareIsatuximabSubcutaneousAndVeinTreatment with Pomalidomide and Dexamethasone CombinationAdult patients with relapsed and/or refractory multiple myelomaEfficacy and safety. In the study, subcutaneous injectionIsatuximabWillOnce weekly administration, lasting for 4 weeks (Cycle 1), with the nominal dose administered on Day 1 and Day 15 of each subsequent cycle. The product will be administered by healthcare professionals (on-site administration, or from Cycle 6 onwards, at-home administration on Day 15). This means that patients can hopefully experience enhanced convenience in medication administration, facilitating treatment.[1] Sanofi's anti-CD38 monoclonal antibody Sarclisa® approved in China, becoming the first blood tumor treatment drug approved based on real-world study data from Lecheng as key evidence. Retrieved Jan 9, 2025, from https://mp.weixin.qq.com/s/78_6rKwtGYvShJB6q7qmgw[2].LiuJ, Liu W, Mi L, et al. Incidence and mortality of multiple myeloma in China,2006-2016: an analysis of the Global Burden of Disease Study 2016. J Hematol Oncol 12, 136 (2019).[3] Heavyweight! The New Generation CD38 Monoclonal Antibody Sarclisa® (Isatuximab) Lands in the Guangdong-Hong Kong-Macao Greater Bay Area. Retrieved Feb 27, 2023, from https://mp.weixin.qq.com/s/YtclODVSgzVImnFlhlt1Qw[4] Press Release: ASCO: Sarclisa is first anti-CD38 to significantly improve progression-free survival in combination with VRd for newly diagnosed transplant-ineligible multiple myeloma in phase 3. Retrieved Jun 4, 2024, from https://www.sanofi.com/en/media-room/press-releases/2024/2024-06-03-20-15-00-2892607[5] Double Celebration! Isatuximab Two Phase III Trials Meet Primary Endpoints, Poised to Benefit a Wide Range of Newly Diagnosed Multiple Myeloma Patients. Retrieved Dec 13, 2023, from https://mp.weixin.qq.com/s/Akix3eLzOxjgFI2sBX6_7AThis article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media, but unauthorized reproduction by media or institutions in any form to other platforms is strictly prohibited. For authorization to reproduce,For other collaboration needs, please contact wuxi_media@wuxiapptec.com.
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