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2022-08-24T13:14:00.000Z

KarMMa-3 trial of ide-cel vs SOC in RRMM meets its primary endpoint

Aug 24, 2022
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Learning objective: After reading this article, learners will be able to cite a new clinical development in relapsed/refractory MM

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On August 10, 2022, positive topline results were announced from the phase III KarMMa-3 trial (NCT03651128), which is comparing idecabtagene vicleucel (ide-cel) with standard combination regimens in patients with multiple myeloma that has been treated with two to four prior lines of therapy and is refractory to the last regimen.1

Following the prespecified interim analysis, it’s been established that the trial has met its primary endpoint of a statistically significant improvement in progression-free survival with ide-cel. Of note, this is the first randomized trial of a chimeric antigen receptor (CAR) T-cell therapy in multiple myeloma to communicate positive results. Further data from the KarMMa-3 trial will be released in a scientific conference soon.1

Idecabtagene vicleucel1

In March 2021, ide-cel became the first B-cell maturation antigen (BCMA)-targeted CAR T-cell therapy approved by the U.S. Food and Drug Administration (FDA) following data from the KarMMA trial. Similarly, ide-cel was granted a conditional marketing license by the European Commission (EC) in August 2021. Ide-cel is licensed for use after ≥4 prior lines of therapy by the FDA and ≥3 prior lines of therapy by the EC.

KarMMa-3 trial

The design of the KarMMa-3 trial, including inclusion/exclusion criteria and efficacy measures, can be seen Figure 1.

Figure 1. Design of the KarMMa-3 trial* 

allo-SCT, allogeneic stem cell transplant; auto-SCT, autologous stem cell transplant; BCMA, B-cell maturation antigen; CNS, central nervous system; COPD, chronic obstructive pulmonary disease; CR, complete remission; DOR, duration of response; DPd, daratumumab, pomalidomide, dexamethasone; DVd, daratumumab, bortezomib, dexamethasone; EPd, elotuzumab, pomalidomide, dexamethasone; ide-cel, idecabtagene vicleucel; IRd, ixazomib, lenalidomide, dexamethasone; ECOG, Eastern Cooperative Oncology Group; EFS, event-free survival; IMiD, immunomodulatory imide drug; Kd, carfilmozib, dexamethasone; MM, multiple myeloma; MRD, minimal residual disease; NGS, next-generation sequencing; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; POEMS,  polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes; PS, performance status; RRMM, relapsed/refractory multiple myeloma.
*Data from ClinicalTrials.gov.2

 Results1

This trial plans to recruit a total of 381 patients aged ≥18 years. The prespecified interim analysis demonstrated a statistically significant improvement in progression-free survival with ide-cel compared with traditional regimens, as well as improved overall response rates and overall survival rates. In addition, the safety and tolerability of ide-cel was reported to be consistent with prior clinical trial data. Further endpoint data are anticipated.

Of note, initial data from a multicenter study of ide-cel in a real-world setting were recently reported by Doris Hansen at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. In the video below, Hansen discusses these initial data from a total of 159 patients.

Is experience with ide-cel CAR-T in the real-world setting comparable to the KarMMa trial results?

  1. Bristol Myers Squibb. Bristol Myers Squibb and 2seventy bio announce topline results from KarMMa-3 trial showing Abecma (idecabtagene vicleucel) significantly improves progression-free survival versus standard regimens in relapsed and refractory multiple myeloma. https://news.bms.com/news/details/2022/Bristol-Myers-Squibb-and-2seventy-bio-Announce-Topline-Results-from-KarMMa-3-Trial-Showing-Abecma-idecabtagene-vicleucel-Significantly-Improves-Progression-Free-Survival-Versus-Standard-Regimens-in-Relapsed-and-Refractory-Multiple-Myeloma/default.aspx. Published Aug 10, 2022. Accessed Aug 18, 2022.
  2. ClinicalTrials.gov. Efficacy and safety study of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM) (KarMMa-3). https://clinicaltrials.gov/ct2/show/NCT03651128. Updated Aug 2, 2022. Accessed Aug 23, 2022.

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