All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the International Myeloma Foundation or HealthTree for Multiple Myeloma.

The Multiple Myeloma Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

An expert panel hosted by

The Lymphoma Hub logo and the Multiple Myeloma Hub logo

Sequencing immune-based therapies in B-cell malignancies

with Ulric Jäger, Sagar Lonial, and Krina Patel

Saturday, June 15 | 18:00-19:30 CEST

Register now

This independent education activity is sponsored by Bristol Myers Squibb. All content is developed independently by the faculty. Funders are allowed no direct influence on the content of this activity.


The Multiple Myeloma Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the Multiple Myeloma Hub cannot guarantee the accuracy of translated content. The Multiple Myeloma Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact
You're logged in! Click here any time to manage your account or log out.
You're logged in! Click here any time to manage your account or log out.

Positive EMA’s CHMP opinion announced for isatuximab with carfilzomib and dexamethasone in relapsed MM

Mar 3, 2021

The Committee for Medicinal Products for Human Use (CHMP) from the European Medicines Agency (EMA) has issued on Feb 25, 2021 a positive opinion for isatuximab (isa) in combination with carfilzomib and dexamethasone (Kd), for adult patients with multiple myeloma (MM) who had been previously treated with at least one line of therapy.1

The opinion was based on the results of the phase III IKEMA study (NCT03275285) in patients with MM who had received 1−3 lines of treatment. In this study, isatuximab combined with Kd was tested against Kd only. During the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, the interim trial analysis was presented.2 The primary endpoint of this study was progression-free survival (PFS), while overall response rate, very good partial response, and complete response were the secondary endpoints.

After a median follow-up of 20.7 months, patients in the isa-Kd group showed improved responses compared with the Kd group in all categories (Table 1).

Table 1. Outcomes in the IKEMA trial2


Isa-Kd (n = 179)

Kd (n = 123)

p value

≥ VGPR, %




≥ CR, %




MRD-negative*, %




MRD-negative + CR, %




CR, complete response; d, dexamethasone; Isa, isatuximab; K, carfilzomib; MRD, measurable residual disease; VGPR, very good partial response.

*MRD assessed by next-generation sequencing (NGS) at 10−5 sensitivity level.

Overall, the median PFS with isa-Kd has not been reached, but was longer than with Kd, with a hazard ratio (HR) of 0.531 (99% CI, 0.318–0.889) favoring the triplet arm. More prolonged PFS survival was associated with achieving measurable residual disease (MRD) negativity in both treatment arms (Table 2), but still, isa-Kd achieved a greater PFS benefit for both MRD-negative and MRD-positive patients.

Table 2. PFS according to treatment groups and measurable residual disease status2



95% CI

Isa-Kd MRD-negative



Kd MRD-negative

Isa-Kd MRD-positive



Kd MRD-positive

d, dexamethasone; Isa, isatuximab; K, carfilzomib; MRD, measurable residual disease.

The combination of isa-Kd is not yet approved for usage in the EU; however, the final decision is expected in the coming months from the European Commission.

Isatuximab is an anti-CD38 monoclonal antibody that triggers apoptosis in MM cells and has immunomodulatory effects. It has so far been approved by the U.S. Food and Drug Administration (FDA) and the EMA in patients with relapsed/refractory MM who have been previously treated with at least two lines of therapy.

  1. European Medicines Agency (EMA). Sarclisa. Published Feb 26, 2021. Accessed Mar 2, 2021.
  2. Martin T, Mikhael J, Hajek R, et al. Depth of response and response kinetics of isatuximab plus carfilzomib and dexamethasone in relapsed multiple myeloma: Ikema interim analysis. 2020;136(Supplement 1):7-8. DOI:


Subscribe to get the best content related to multiple myeloma delivered to your inbox