Thomas Martin1, Saad Z Usmani2, Jesus G Berdeja3, Mounzer Agha4, Adam D Cohen5, Parameswaran Hari6, David Avigan7, Abhinav Deol8, Myo Htut9, Alexander Lesokhin2, Nikhil C Munshi10,11, Elizabeth O'Donnell12, A Keith Stewart13, Jordan M Schecter14, Jenna D Goldberg14, Carolyn C Jackson14, Tzu-Min Yeh14, Arnob Banerjee15, Alicia Allred15, Enrique Zudaire15, William Deraedt16, Yunsi Olyslager16, Changwei Zhou17, Lida Pacaud17, Deepu Madduri14, Andrzej Jakubowiak18, Yi Lin19, Sundar Jagannath20. 1. UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA. 2. Memorial Sloan Kettering Cancer Center, New York, NY. 3. Sarah Cannon Research Institute, Nashville, TN. 4. UPMC Hillman Cancer Center, Pittsburgh, PA. 5. Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA. 6. Medical College of Wisconsin, Milwaukee, WI. 7. Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA. 8. Karmanos Cancer Institute, Wayne State University, Detroit, MI. 9. City of Hope Comprehensive Cancer Center, Duarte, CA. 10. Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA. 11. VA Boston Healthcare System, West Roxbury, MA. 12. Massachusetts General Hospital, Harvard Medical School, Boston, MA. 13. University Health Network and the Princess Margaret Cancer Centre, Toronto, ON, Canada. 14. Janssen R&D, Raritan, NJ. 15. Janssen R&D, Spring House, PA. 16. Janssen R&D, Beerse, Belgium. 17. Legend Biotech, Inc, Piscataway, NJ. 18. University of Chicago, Chicago, IL. 19. Mayo Clinic, Rochester, MN. 20. Mount Sinai Medical Center, New York, NY.
Abstract
PURPOSE: CARTITUDE-1, a phase Ib/II study evaluating the safety and efficacy of ciltacabtagene autoleucel (cilta-cel) in heavily pretreated patients with relapsed/refractory multiple myeloma, yielded early, deep, and durable responses at 12 months. Here, we present updated results 2 years after last patient in (median follow-up [MFU] approximately 28 months), including analyses of high-risk patient subgroups. METHODS: Eligible patients had relapsed/refractory multiple myeloma, had received ≥ 3 prior lines of therapy or were double refractory to a proteasome inhibitor and immunomodulatory drug and had received prior proteasome inhibitor, immunomodulatory drug, and anti-CD38 therapy. Patients received a single cilta-cel infusion 5-7 days after lymphodepletion. Responses were assessed by an independent review committee. RESULTS: At a MFU of 27.7 months (N = 97), the overall response rate was 97.9% (95% CI, 92.7 to 99.7); 82.5% (95% CI, 73.4 to 89.4) of patients achieved a stringent complete response. Median duration of response was not estimable. Median progression-free survival (PFS) and overall survival (OS) were not reached; 27-month PFS and OS rates were 54.9% (95% CI, 44.0 to 64.6) and 70.4% (95% CI, 60.1 to 78.6), respectively. Overall response rates were high across all subgroups (95.1%-100%). Duration of response, PFS, and/or OS were shorter in patients with high-risk cytogenetics, International Staging System stage III, high tumor burden, or plasmacytomas. The safety profile was manageable with no new cilta-cel-related cytokine release syndrome and one new case of parkinsonism (day 914 after cilta-cel) since the last report. CONCLUSION: At approximately 28 months MFU, patients treated with cilta-cel maintained deep and durable responses, observed in both standard and high-risk subgroups. The risk/benefit profile of cilta-cel remained favorable with longer follow-up.
PURPOSE: CARTITUDE-1, a phase Ib/II study evaluating the safety and efficacy of ciltacabtagene autoleucel (cilta-cel) in heavily pretreated patients with relapsed/refractory multiple myeloma, yielded early, deep, and durable responses at 12 months. Here, we present updated results 2 years after last patient in (median follow-up [MFU] approximately 28 months), including analyses of high-risk patient subgroups. METHODS: Eligible patients had relapsed/refractory multiple myeloma, had received ≥ 3 prior lines of therapy or were double refractory to a proteasome inhibitor and immunomodulatory drug and had received prior proteasome inhibitor, immunomodulatory drug, and anti-CD38 therapy. Patients received a single cilta-cel infusion 5-7 days after lymphodepletion. Responses were assessed by an independent review committee. RESULTS: At a MFU of 27.7 months (N = 97), the overall response rate was 97.9% (95% CI, 92.7 to 99.7); 82.5% (95% CI, 73.4 to 89.4) of patients achieved a stringent complete response. Median duration of response was not estimable. Median progression-free survival (PFS) and overall survival (OS) were not reached; 27-month PFS and OS rates were 54.9% (95% CI, 44.0 to 64.6) and 70.4% (95% CI, 60.1 to 78.6), respectively. Overall response rates were high across all subgroups (95.1%-100%). Duration of response, PFS, and/or OS were shorter in patients with high-risk cytogenetics, International Staging System stage III, high tumor burden, or plasmacytomas. The safety profile was manageable with no new cilta-cel-related cytokine release syndrome and one new case of parkinsonism (day 914 after cilta-cel) since the last report. CONCLUSION: At approximately 28 months MFU, patients treated with cilta-cel maintained deep and durable responses, observed in both standard and high-risk subgroups. The risk/benefit profile of cilta-cel remained favorable with longer follow-up.