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Second Sarclisa combination regimen for multiple myeloma approved in EU

Second indication for Sarclisa covers drug’s use in combination with another standard myeloma treatment

Sanofi’s Sarclisa has received approval from the European Commission to treat patients with relapsed multiple myeloma who have received at least one prior therapy.

Sarclisa is designed to target the CD38 protein found on the surface of myeloma cells, inducing programmed tumour cell death – also known as apoptosis.

In the EU, Sarclisa is already approved for use in combination with pomalidomide and dexamethasone (pom-dex), a standard regimen for the treatment of myeloma, for the treatment of patients with relapsed or refractory multiple myeloma.

The second indication for Sarclisa covers the drug’s use in combination with another standard myeloma treatment regimen – carfilzomib and dexamethasone (Kd) – for the treatment of relapsed multiple myeloma in patients who have received at least one prior therapy.

In March 2021, the US Food and Drug Administration (FDA) approved Sarclisa in combination with Kd for the treatment of relapsed or refractory multiple myeloma in patients who have received one to three prior lines of therapy.

In the phase 3 IKEMA trial, which enrolled 302 patients with relapsed multiple myeloma, the median progression-free survival (PFS) had not been reached for patients receiving Sarclisa plus Kd at the time of the interim analysis, with patients receiving Kd alone demonstrating a median PFS of 19.15 months.

The overall response rate (ORR) was similar for each arm – 86.6% for the Sarclisa combination group versus 82.9% for Kd alone.

In the Sarclisa combination arm, the complete response (CR) rate was 39.7% compared with 27.6% in the Kd arm.

The rate of very good partial response (VGPR) was 72.6% for the Sarclisa combination group was 72.6% and 56.1% for patients receiving Kd alone.

In addition, MRD-negativity was observed in 29.6% of patients receiving the Sarclisa treatment regimen versus 13% in the Kd arm, meaning that nearly 30% of patients treated with Sanofi’s drug achieved undetectable levels of multiple myeloma at 10-5 sensitivity, as measured by next generation sequencing.

“The carfilzomib and dexamethasone [Sarclisa] combination represents an important standard of care in Europe,” said Peter Adamson, global development head, oncology and paediatric innovation at Sanofi.

“The phase 3 IKEMA trial’s finding that the addition of Sarclisa to this regimen reduced the risk of progression or death by nearly half formed the basis for this important EC approval,” he added.

A host of new treatments for myeloma have entered the market over the last decade, but despite these advancements patients often relapse or become resistant to certain therapies.

That makes the later line drugs, such as Sarclisa, important for those patient who have exhausted other options.

Article by
Lucy Parsons

19th April 2021

From: Regulatory



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