Adding Sarclisa (isatuximab) to a treatment regimen of Kyprolis (carfilzomib) and dexamethasone – a two-drug combination known as Kd – extended the life of patients with pretreated relapsed myeloma before their disease from getting worse, according to results from the Phase 3 IKEMA clinical trial.
The study, which led to the diet’s approval by the Food and Drug Administration (FDA) in 2021, compared the outcomes of patients with relapsed myeloma who had been treated with one to three prior treatments. Study participants were randomly assigned to receive Sarclisa (an intravenous drug) plus Kd or Kd alone, with the endpoint of the trial being progression-free survival (the length of time a patient lives without their disease gets worse).
The researchers also looked at the overall response rate (percentage of patients whose disease decreased as a result of treatment), complete response rate (percentage of patients who had no detectable cancer after treatment), very good or partial response rates, minimal residual rates of disease negativity, overall survival (time between treatment and death from any cause) and safety.
The mean progression-free survival for the Sarclisa-containing group was 35.7 months, compared with 19.2 months for patients treated with Kd alone, as reviewed by an independent review board. Censored analysis conducted by the FDA, which removes some patients from the data pool before they experience progression, mean progression-free survival was 41.7 months in the Sarclisa plus Kd group, compared to 20.8 months in patients processed only with Kd.
“The increase in progression-free survival, consistently observed across all subgroups, when Sarclisa is added to (Kyprolis) and dexamethasone is remarkable in patients with relapsed multiple myeloma in a combination of proteasome inhibitors,” said Dr Philippe Moreau, head of the hematology department. at Nantes University Hospital in France, said in a press release.
In addition, treatment with Sarclisa improved the amount of time patients had before needing to move on to the next treatment. On average, the Sarclisa group waited 44.9 months for the next treatment, compared to 25 months in the Kd alone group.
There were no new side effects observed with IKEMA that were not previously seen in previous clinical trials with Sarclisa. The most common adverse reaction in patients receiving Sarclisa was: infusion reaction (45.8% and 3.3% in the Sarclisa and Kd alone groups, respectively), diarrhea (39.5% and 32%, respectively ), high blood pressure (37.9% and 35.2%), upper respiratory tract infection (37.3% and 27%), fatigue (31.6% and 20.5%), breathing difficulties (30.5 % and 22.1%), pneumonia (27.1% and 21.3%), back pain (25.4% and 21.3%), insomnia (25.4% and 24.6%) and bronchitis ( 24.3% and 12.3%).
“Relapses are common in multiple myeloma, creating the need for differentiated second-line treatments that offer patients a longer period of time without disease progression. This updated analysis reinforces Sarclisa’s potential to become a new standard of care for patients with relapsed multiple myeloma,” said Moreau.
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