Sanofi’s Sarclisa (isatuximab) plus standard of care has been shown to extend the time that some multiple myeloma patients remain stable without disease progression.
This was demonstrated in a Phase III trial (NCT03617731) with 662 newly diagnosed patients who were eligible for a stem cell transplant. The trial found that adding Sarclisa to the standard drugs – lenalidomide, bortezomib, and dexamethasone (Rvd) – resulted in a statistically significant and clinically meaningful improvement in progression-free survival compared to RVd induction therapy.
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Sanofi said that these results reinforce the potential of Sarclisa as a backbone therapy when added to the current standard of care in various multiple myeloma patient populations.
These recent findings build on data from 2021, where the trial met a different primary endpoint of minimal residual disease (MRD) negativity after induction therapy and before transplant. Around 50.1% of the newly diagnosed multiple myeloma patients achieved undetectable levels of disease after 18 weeks of induction treatment with Sarclisa and RVd.
Sarclisa is already approved in the US and the EU, in combination with several different drugs for relapsed refractory multiple myeloma, but Sanofi plans to expand its label to earlier settings.
However, if Sarclisa gains approval in this setting, it would be competing with Johnson & Johnson’s monoclonal antibody Darzalex (daratumumab). Darzalex is in the lead, winning US Food and Drug Administration (FDA) approval in September 2019 in combination with bortezomib, thalidomide and dexamethasone for transplant-eligible patients. Darzalex generated $9.7bn in 2023, as per the company’s financials.
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By GlobalDataSarclisa is a monoclonal antibody that works by targeting and binding to CD38 on multiple myeloma cells, leading to direct cell death, enhanced immune-mediated destruction, and induction of apoptosis. According to GlobalData’s Pharma Intelligence Center, Sarclisa is forecast to generate $887m in 2030 while Darzalex, which also targets CD38, is set to pull in $20bn in the same year.
GlobalData is the parent company of Clinical Trials Arena.
In the announcement accompanying the data, Sanofi’s chief medical officer Dietmar Berger said: “The GMMG-HD7 study was designed to better understand the distinct effect of targeting CD38 with Sarclisa in induction versus maintenance treatment of transplant-eligible patients.
“These data build upon our belief that Sarclisa has the potential to be a best-in-class CD38 therapy that could improve long-term outcomes versus the standard of care for certain patients.”
