The European Commission (EC) has approved Sanofi‘s Sarclisa (isatuximab), in a triple combination with Pomalyst (pomalidomide) and dexamethasone, to treat adults with relapsed or refractory multiple myeloma.
The approval is specifically for those who have tried at least two previous types of treatment, to include Revlimid (lenalidomide) and a proteasome inhibitor, and experienced disease progression on the most recent therapy. It covers the 27 member states of the European Union, as well as the United Kingdom, Iceland, Liechtenstein, and Norway.
“The EC approval of Sarclisa represents an important additional therapeutic option and may set a new standard of care for myeloma patients in Europe who are in need of new effective treatments because their disease has returned or they have become refractory to their previous treatment,” John Reed, MD, PhD, global head of research and development at Sanofi, said in a press release.
The recent approvals were based on data from the ICARIA-MM Phase 3 trial (NCT02990338), which tested Sarclisa’s safety and efficacy when used in combination with Pomalyst and dexamethasone, the standard therapy for relapsed or refractory myeloma. Pomalyst is an oral immunomodulatory treatment, while dexamethasone is a corticosteroid.
ICARIA-MM enrolled 307 myeloma patients who had received at least two previous lines of therapy, including Revlimid and a proteasome inhibitor. Participants were randomly assigned to treatment with either the Sarclisa combination with standard Pomalyst and dexamethasone, or standard treatment only.
Compared with just Pomalyst and dexamethasone, the addition of Sarclisa significantly extended the time patients lived without disease worsening, from 6.5 months to 11.5 months. That represented a 40% reduction in the risk of disease progression or death.
“Sarclisa in combination with pom-dex [Pomalyst and dexamethasone] demonstrated median progression-free survival of nearly one year, a five-month improvement over pom-dex alone, in patients who had already failed at least two prior therapies,” Reed said.
The trial findings also showed that significantly more participants on Sarclisa responded to treatment, compared with those receiving standard treatment only (60.4% vs. 35.3%).
The treatment benefit of Sarclisa was consistent across several subgroups, including people age 75 or older, those with kidney problems, patients who did not respond to treatment with Revlimid, and people with genetic abnormalities in their cancer cells that indicate a higher disease risk.
“As patients experience relapse of their multiple myeloma or become refractory to their current therapy, they become more difficult to treat with increasingly poor prognoses,” said Philippe Moreau, MD, ICARIA-MM investigator at the University Hospital of Nantes in France.
“In the ICARIA-MM trial, Sarclisa combination therapy showed a treatment benefit consistent across relapsed and refractory multiple myeloma subgroups,” Moreau added. “Sarclisa offers an important new treatment option and a potentially new standard of care for these patients with relapsed, refractory disease.”
The most frequently reported adverse reactions associated with Sarclisa treatment were neutropenia, or low neutrophil — a type of white blood cell — counts (47%), infusion reactions (38.2%), and pneumonia (30.9%). Other adverse reactions included upper respiratory tract infection (28.3%), diarrhea (25.7%), and bronchitis (23.7%). The most frequent serious adverse reactions were pneumonia (9.9%) and neutropenia with fever (6.6%).
Sarclisa is given by an intravenous (into-the-vein) infusion, at a dose of 10 mg/kg, in combination with Pomalyst and dexamethasone. Infusions are given every week for four weeks, then every other week until the patient experiences disease progression or signs of toxicity. Generally, the first infusion takes three or four hours, and subsequent infusions take less than two hours.
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