Sarclisa (Isatuximab) Shows Promise in Multiple Myeloma Treatment: China Approval and Subcutaneous Formulation Advances
核心洞察
China's NMPA has approved Sarclisa (isatuximab) in combination with pomalidomide and dexamethasone for relapsed/refractory multiple myeloma (搜索), marking a significant milestone for Sanofi.
A Phase 3 IRAKLIA trial demonstrated that subcutaneous isatuximab, delivered via an on-body system, achieved non-inferior objective response rates compared to intravenous administration.
Regulatory submissions for subcutaneous isatuximab are planned in the US and EU in the first half of 2025, potentially offering a more convenient administration option for patients.
Sanofi's Sarclisa (isatuximab) is making strides in the treatment of multiple myeloma (搜索), with recent developments including approval in China and positive trial results for a subcutaneous formulation. These advancements offer new hope for patients battling this challenging disease.
China Approves Sarclisa for Relapsed/Refractory Multiple Myeloma
China’s National Medical Products Administration (NMPA) has granted approval to Sanofi's Sarclisa (isatuximab) in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma (搜索) who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. This approval was based on data from the Phase 3 ICARIA-MM trial and the real-world IsaFiRsT study.
The ICARIA-MM trial demonstrated that Sarclisa plus Pd significantly reduced the risk of disease progression or death by 40% (HR 0.596, 95% CI 0.44-0.81, p=0.001) and improved overall survival by 6.9 months (HR=0.78; log-rank 1-sided P=0.0319) compared to Pd alone. The IsaFiRsT study, conducted in China, showed an overall response rate (ORR) of 82.6% among relapsed or refractory multiple myeloma (搜索) patients treated with Sarclisa plus Pd.
Olivier Nataf, Global Head of Oncology at Sanofi, stated, "This approval marks an important milestone for Sanofi in China...highlight[ing] the benefit of Sarclisa for patients living with multiple myeloma (搜索) and the importance of innovative regulatory pathways for timely access to different treatments."
Subcutaneous Isatuximab Shows Non-Inferiority in Phase 3 Trial
In addition to the China approval, Sanofi has announced positive results from the Phase 3 IRAKLIA trial, which evaluated a subcutaneous (SC) formulation of isatuximab. The trial met its co-primary endpoints, demonstrating that SC isatuximab, administered via an on-body delivery system (OBDS) in combination with pomalidomide and dexamethasone (Pd), achieved non-inferior objective response rate (ORR) and observed concentration before dosing (C trough) at steady state compared to intravenous (IV) isatuximab plus Pd in patients with relapsed/refractory multiple myeloma (搜索).
The IRAKLIA trial enrolled 531 patients across 252 global sites, who were randomized 1:1 to receive either SC or IV isatuximab in combination with Pd. Key secondary endpoints, including very good partial response (VGPR), incidence rate of infusion reactions, and C trough at cycle 2, were also met.
The SC formulation was administered at a fixed dose using Enable Injections’ enFuse® OBDS, designed for subcutaneous delivery of high-volume medications. This system offers a potentially more convenient administration route for patients.
Sikander Ailawadhi, MD, professor of medicine at Mayo Clinic Florida and principal investigator of the study, noted, "The consistent overall response rate and comparable efficacy and safety profile observed in the IRAKLIA study for subcutaneous Sarclisa represent an exciting advancement, offering insight into a potential new administration option for patients."
Regulatory Outlook and Future Development
Sanofi plans to submit regulatory filings for the subcutaneous isatuximab formulation in the US and European Union in the first half of 2025. Additional studies evaluating subcutaneous isatuximab across different combinations and lines of therapy are ongoing.
These developments underscore Sanofi's commitment to advancing Sarclisa as a key treatment option for multiple myeloma (搜索), with the potential to improve patient outcomes and quality of life.