EU expands Sarclisa approval for wider range of myeloma patients
Newly diagnosed, transplant-eligible patients now eligible for therapy
The European Union (EU) expanded its approval of Sarclisa (isatuximab-irfc), making it available to newly diagnosed adults with multiple myeloma who are eligible for a stem cell transplant.
The medication can be used for these patients alongside Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone — a standard combination called VRd — as an induction regimen, or a first round of cancer treatment designed to eliminate as many cancer cells as possible.
The decision means that Sanofi’s antibody therapy is now approved in the EU across all lines of therapy, regardless of transplant eligibility.
EU regulators earlier this year approved Sarclisa as part of a combination regimen for newly diagnosed, transplant-ineligible patients, as well as a component of two regimens for people with relapsed or refractory multiple myeloma (RRMM), where the cancer was unresponsive to or progressed after other lines of treatment.
“We have been on a mission to accelerate Sarclisa’s clinical development program with the hope to bring this important medicine to as many people as possible living with multiple myeloma,” Olivier Nataf, global head of oncology at Sanofi, said in a company press release.
Potential for broader approval
“Today’s decision represents a prime example of those efforts, and most importantly, paves the way for Sarclisa to potentially become accessible to even more patients in the EU, regardless of transplant eligibility or line of therapy,” Nataf said.
Sarclisa, given via infusions into the bloodstream, is a type of myeloma treatment called a CD38 inhibitor. It is an antibody that binds to the CD38 protein found at high levels on the surface of myeloma cells, triggering their death.
The therapy is approved in more than 50 countries, although specific indications vary. In the U.S., it is cleared as part of two RRMM regimens and for newly diagnosed transplant-ineligible patients, but has not been authorized for newly diagnosed transplant-eligible individuals.
In the EU, the therapy was first approved as part of two different combination treatment regimens for people with RRMM. For newly diagnosed patients — now including both transplant-eligible and ineligible individuals — it is approved for use with VRd.
The decision to expand the EU label to transplant-eligible patients is consistent with a recommendation from a European Medicines Agency committee earlier this summer. It is supported by data from the Phase 3 GMMG-HD7 clinical trial (NCT03617731).
Data from that study, which enrolled 662 transplant-eligible myeloma patients who hadn’t yet been treated, showed that when Sarclisa was added to a standard VRd induction regimen it led to higher rates of minimal residual disease (MRD) negativity than VRd alone. MRD negativity means there are no signs of the small number of cancer cells that can remain after treatment and trigger cancer recurrence.
After induction therapy, all study participants underwent an autologous stem cell transplant, a procedure where the body’s own stem cells are used to boost the production of healthy blood cells in the bone marrow, followed by maintenance treatment with Revlimid or Revlimid plus Sarclisa.
Progression-free survival (PFS), or the time spent alive without cancer progression, was significantly longer in people who had received Sarclisa-VRd induction therapy pre-transplant than in those who had only received VRd, regardless of which post-transplant maintenance regimen they were given.
More people in the Sarclisa-VRd arm experienced continued MRD negativity after transplant than those in the VRd-only arm (53.1% vs. 38%).
Additional data from the maintenance therapy portion of the study, mainly intended to evaluate PFS, are forthcoming, according to Sanofi.
The company is conducting additional studies to evaluate Sarclisa for other multiple myeloma indications. Development of an under-the-skin formulation of the therapy is also underway, with initial data suggesting it is as effective as the original formulation while shortening the administration time.
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