EU panel backs 1st-line Sarclisa for transplant-eligible myeloma
Treatment approved earlier this year for patients not eligible for transplant
A European Medicines Agency committee has recommended that Sarclisa (isatuximab), used in combination with standard-of-care medications, be approved for the treatment of adults newly diagnosed with multiple myeloma who are eligible for a stem cell transplant.
The European Commission will consider the opinion from the Committee for Medicinal Products for Human Use (CHMP) when making a final approval decision in the coming months.
Sarclisa, from Sanofi, is approved in the European Union as part of two regimens for people with relapsed or refractory multiple myeloma, in which the cancer has been unresponsive to or progressed after other lines of treatment. And early this year, EU regulators approved Sarclisa as part of a standard combination regimen for newly diagnosed patients who are not eligible for stem cell transplantation.
The therapy holds similar approvals in the U.S.
“The CHMP’s recommendation represents significant progress toward our ambition for Sarclisa, addressing unmet patient needs in multiple myeloma care and making a meaningful difference in treatment outcomes at every stage of the disease across regions,” Olivier Nataf, global head of oncology at Sanofi, said in a company press release. “If approved, this regimen would represent a new, important induction option for transplant-eligible patients, with the potential to improve long-term outcomes and deepen responses at a critical juncture in treatment.”
Binding to protein
Sarclisa belongs to a class of myeloma treatments called CD38 inhibitors, which trigger the death of myeloma cells by binding to the CD38 protein found at high levels on their surfaces. It’s given via infusions into the bloodstream.
In the EU, Sarclisa is indicated as part of a combination regimen with pomalidomide (sold under the brand name Imnovid in the EU and Pomalyst in the U.S.) and dexamethasone for adults with RRMM after at least two prior lines of therapy, including Revlimid (lenalidomide) and a proteasome inhibitor. It can also be used with Kyprolis (carfilzomib) and dexamethasone for adults after at least one line of therapy.
For newly diagnosed, transplant-ineligible patients, Sarclisa is approved for use with Velcade (bortezomib), Revlimid, and dexamethasone, a standard regimen known as VRd. It will also be used in combination with VRd for treating transplant-eligible patients if regulators approve it for this indication.
The CHMP’s recommendation is based on results from the first part of the Phase 3 GMMG HD7 clinical trial (NCT03617731), which enrolled more than 650 transplant-eligible myeloma patients who were newly diagnosed and had not yet been treated.
Participants were randomly assigned to receive three cycles of VRd either alone or with Sarclisa as an induction regimen, used at the beginning of cancer treatment to eliminate as many cancer cells as possible.
The main goal was to evaluate the proportion of participants in either group who achieved minimal residual disease (MRD) negativity, referring to an absence of the small number of cancer cells that can persist after therapy and trigger future disease progression.
Results showed that MRD negativity was achieved by more people using Sarclisa compared than VRd alone (66% vs. 48%), meeting the study’s main goal.
After induction therapy, participants all underwent autologous stem cell transplant, a procedure in which the body’s own stem cells are used to increase production of healthy blood cells in the bone marrow.
Participants were then randomly assigned to maintenance treatment with Revlimid, used alone or in combination with Sarclisa.
The data showed that people who had initially received Sarclisa-VRd induction therapy before the transplant experienced significantly longer progression-free survival — the time spent alive without cancer progression — than those who received VRd alone, regardless of which maintenance regimen was given after the transplant.
While awaiting a decision from European regulators, Sanofi is conducting additional clinical trials to evaluate Sarclisa for other indications in multiple myeloma.
It’s also developing an under-the-skin (subcutaneous) formulation of Sarclisa, administered via an on-body injector, that the company says could be less burdensome for patients.
This formulation has been found to be as effective as the intravenous formulation in clinical testing, while substantially shortening the administration time. Sanofi has said the data will form the basis for regulatory submissions seeking approval of this subcutaneous formulation.
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