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Idecabtagene Vicleucel Meets ORR Endpoint in Relapsed/Refractory Multiple Myeloma

Gina Columbus @ginacolumbusonc
Published: Saturday, Dec 07, 2019

Kristen Hege, MD, senior vice president, Hematology/Oncology and Cell Therapy, Early Clinical Development for Bristol-Myers Squibb

Kristen Hege, MD

Treatment with the BCMA-targeted CAR T-cell therapy idecabtagene vicleucel (ide-cel; bb2121) was associated with a 73.4% overall response rate (ORR) in patients with relapsed/refractory multiple myeloma, meeting the primary endpoint of the pivotal phase II KarMMA trial (NCT03361748).1

Regarding safety, the results were consistent with what was observed in the phase I CRB-401 trial. Grade ≥3 cytokine release syndrome (CRS) occurred in 5.5% of patients, and 1 death occurred due to a CRS event; grade ≥3 neurotoxicity events occurred in 3.1% of patients; no grade 4 events were reported. Additionally, grade ≥3 CRS and neurotoxicity events were reported in <6% of each target dose. All-grade CRS and neurotoxicity events occurred in 83.6% and 18% of patients, respectively.


  1. Bristol-Myers Squibb and bluebird bio announce positive top-line results from the pivotal phase 2 KarMMa study of ide-cel in relapsed and refractory multiple myeloma. Bristol-Myers Squibb. Published December 6, 2019. Accessed December 6, 2019.
  2. Raje NS, Berdega JG, Lin BY, et al. bb2121 anti-BCMA CAR T-cell therapy in patients with relapsed/refractory multiple myeloma: updated results from a multicenter phase I study. J Clin Oncol. 2018;36(suppl; abstr 8007). doi: 10.1200/JCO.2018.36.15_suppl.8007.

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