Nina Shah, MD, Discusses Key Results of the Phase 2 KarMMa Trial of Ide-Cel in R/R Multiple Myeloma
At the 2022 Tandem Meetings, Nina Shah, MD, spoke about key findings from the phase 2 KarMMa trial that used idecabtagene vicleucel in patients with relapsed/refractory multiple myeloma.
CancerNetwork® spoke with Nina Shah, MD, a hematologist oncologist from University of California San Francisco Health, as part of an interview during the 2022 Tandem Meeting about key results of the phase 2 KarMMA trial (NCT03361748) assessing idecabtagene vicleucel (ide-cel; Abecma) in patients with relapsed/refractory multiple myeloma who have received 4 or more lines of therapy.1 The upcoming presentation at the meeting will focus on patients who achieved a complete response in relation to treatment.
Shah highlighted how results from the trial led to the FDA approval for ide-cel in March 2021 in previously treated multiple myeloma.2 Patients had a median peak of CAR T-cell expression at 11 days and persistence was durable, with CAR T-cells being detected in 59% of patients at 6 months, and 36% at 12 months.
Transcript:
The phase 2 single-arm KarMMa [trial] was a study of [patients with] relapsed/refractory multiple myeloma who received single-agent BCMA-directed CAR T-cell therapy, also known as ide-cel. In this study, patients were heavily pretreated with 6 median prior lines of [therapy] and they were all refractory to their last treatment. We now know that at all dose levels, there was a response rate [of over 70%] with an overall median PFS [progression-free survival] of a little over 8 months.
CRS [cytokine release syndrome] was only [present] in 84% [of patients], but it was generally grade 1 or 2, and neurotoxicity occurred in about 18% of patients. Because of this, and some good quality of life data, [ide-cel] was ultimately FDA approved for patients with relapsed/refractory multiple myeloma with at least 4 prior lines of therapy.
References
- Shah N, Munshi N, Berdeja JG, et al. Baseline correlates of complete response to idecabtagene vicleucel (ide-cel, bb2121), a BCMA-directed CAR T cell therapy in patients with relapsed and refractory multiple myeloma (RRMM): subanalysis of the KarMMa trial. Presented at the 2022 Tandem Meetings. April 22-26, 2022. Poster 223.
- FDA approved idecabtagene vicleucel for multiple myeloma. News Release. FDA. March 26, 2021. Accessed April 22, 2022. https://bit.ly/3xGMqcq
