The National Medical Products Administration (NMPA) in China has approved Sarclisa (isatuximab) in combination with pomalidomide and dexamethasone (Pd) for adults with multiple myeloma (MM) who have undergone at least one prior therapy, including lenalidomide and a proteasome inhibitor.
As per the press release, this decision is based on findings from the ICARIA-MM phase 3 trial and the China-based IsaFiRsT real-world study. The ICARIA-MM trial showed that adding Sarclisa to Pd reduced the risk of disease progression or death by 40% (HR 0.596; p=0.001) and improved overall survival (OS) by 6.9 months (HR 0.78; p=0.0319) compared to Pd alone. The IsaFiRsT study further confirmed the treatment’s efficacy, with an 82.6% overall response rate (ORR) in Chinese patients with relapsed or refractory MM.
Advancing Approvals Through Real-World Evidence
Sarclisa is the first blood cancer treatment in China approved using real-world evidence (RWE) alongside clinical trial data under the Lecheng Pilot program. This initiative accelerates regulatory reviews for innovative therapies using real-world data.
Inclusion in Treatment Guidelines
Sarclisa-Pd has received Category I Recommendation status in the Chinese Society of Clinical Oncology (CSCO) and Chinese Anti-Cancer Association (CACA) guidelines as a preferred option for first-relapsed MM. Sanofi has also submitted a regulatory application for Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed MM patients ineligible for stem cell transplants, with a decision anticipated soon.
Global Perspective
Sarclisa, a monoclonal antibody targeting CD38 on MM cells, is currently approved in over 50 countries for multiple indications. It is also being studied in phase 2 and 3 trials across six potential MM indications and for subcutaneous delivery methods.
As per the press release, Olivier Nataf, Global Head of Oncology at Sanofi, emphasized the significance of the approval: “This milestone demonstrates Sarclisa’s potential to address unmet needs in multiple myeloma. We are committed to strengthening partnerships and providing innovative therapies to patients in China and beyond.”
Sanofi’s continued focus on immunoscience innovation underpins its mission to transform treatment paradigms for complex cancers, including MM, acute myeloid leukemia, and lung cancers.