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Krina K. Patel, MD, MSc, discusses the background of the phase 3 KarMMa-3 trial, which investigated idecabtagene vicleucel in patients with high-risk, relapsed/refractory multiple myeloma.
Krina K. Patel, MD, MSc, associate professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the background of the phase 3 KarMMa-3 trial (NCT03651128), which investigated idecabtagene vicleucel (ide-cel, Abecma) in patients with high-risk, relapsed/refractory multiple myeloma.
The KarMMa-3 study was the first randomized trial investigating BCMA-specific CAR T-cell therapy in patients with multiple myeloma, Patel begins. This trial confirmed that CAR T-cell therapy elicited better outcomes in this population than the current standard-of-care (SOC) treatment options, she explains. SOC CAR T-cell therapy is approved in the fifth line and beyond for patients with multiple myeloma. However, most patients with high-risk disease can't wait until the fifth line to receive this therapy, Patel says. This unmet need within the multiple myeloma treatment landscape necessitates earlier treatment with CAR T-cell therapy, she notes, adding that when the KarMMa-3 trial began enrollment, a lot of high-risk patients were enrolled.
Investigators aimed to complete a subgroup analysis of the KarMMa-3 regimen in patients with high-risk disease because it was found that 43.5% of patients fell into a high-risk category, Patel expands. Additionally, it is important to highlight that all patients with multiple myeloma have different disease circumstances, as some patients are diagnosed earlier or later than other patients, she explains, affecting when they are treated with a specific approach. New treatments are now entering the treatment arena, but they are also given in earlier lines now. Therefore, when patients relapse in their third or fourth line, they are at much higher risk compared with patients who relapse earlier, Patel emphasizes.
This high-risk subgroup analysis highlighted that high-risk cytogenetics are not the only disease characteristic that should be considered when determining patient outcomes, Patel continues. Further research will investigate the disease categories that should be considered when determining patient prognoses. This research may lay the foundation for future treatment approaches in high-risk patients, she concludes.
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