Updated Results in Phase 1b/2 CARTITUDE-1 Study of Cilta-Cel in RRMM patients (https://www.myeloma.org/videos/updated-results-phase-1b2-cartitude-1-study-cilta-cel-rrmm-patients)
Updates on Phase 1b/2 of CARTITUDE-1 (Cilta-Cel) Study Presented at ASCO 2022
Dr. Saad Usmani Discusses Updated Results (2 years post-LPI) in Phase 1b/2 (CARTITUDE-1) Study of Cilta-Cel in RRMM patients
Abstract Title:
Phase 1b/2 study of ciltacabtagene autoleucel, a BCMA-directed CAR-T cell therapy, in patients with relapsed/refractory multiple myeloma (CARTITUDE-1): Two years post-LPI.
What is the purpose of this trial?
Ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor T (CAR T) cell therapy with 2 B-cell maturation antigen (BCMA)–targeting single-domain antibodies, led to early, deep, and durable responses in the phase 1b/2 CARTITUDE-1 study (NCT03548207) in heavily pretreated patients (pts) with relapsed/refractory multiple myeloma (RRMM).
Primary objectives were to evaluate cilta-cel safety and efficacy with response assessed per International Myeloma Working Group (IMWG) criteria by independent review committee and minimal residual disease (MRD) negativity at 10-5 by next-generation sequencing.
Updated results 2-year post last patient in (LPI) will be presented (̃30-month total median follow-up). Here, CARTITUDE-1 results are reported at 21.7-month median follow-up (MFU).
In this video:
Dr. Saad Usmani (Memorial Sloan Kettering Cancer Center—New York, NY) discusses updated results (2 years post-LPI) in phase 1b/2 (CARTITUDE-1) study of ciltacabtagene autoleucel (cilta-cel) in relapsed/refractory myeloma (RRMM) patients.
Conclusion:
At ̃2-year median follow-up (MFU), a single cilta-cel infusion led to deepening and durable responses in heavily pretreated patients with RRMM with a manageable safety profile. Follow-up is ongoing, and landmark 2-year post last patient in (LPI) data (̃8 m additional follow-up; ̃30 m total MFU) will be presented. Further investigations of cilta-cel are ongoing in earlier lines of therapy (LOT) and outpatient settings across the CARTITUDE program (NCT04133636, NCT04181827, NCT04923893).
Clinical trial information: NCT03548207
Saad Zafar Usmani, MD, MBA, FACP, FASCO
(Memorial Sloan Kettering Cancer Center—New York, NY)
Dr. Saad Usmani is the Professor and Chief of Myeloma Service at the Memorial Sloan Kettering Cancer Center, New York, NY. He is also the Chair of the ALLIANCE Myeloma Committee, one of the three US Cooperative Groups. He has authored more than 350 peer-reviewed research manuscripts. He has received several international awards recognizing his clinical and translational research contributions to the field, including the LLS Scholar in Clinical Research, the International Myeloma Society Bart Barlogie Award for Clinical and Translational Research, and the Giants in Cancer Care Award.
Dr. Usmani has led the clinical development of several novel therapies, including anti-CD38 monoclonal antibodies, bispecific antibodies and CART cell therapies resulting in regulatory approvals in multiple myeloma. Active in translational research, Dr. Usmani’s work has focused on high-risk multiple myeloma. He has also championed to bring to the forefront the racial disparities impacting the treatment and response to multiple myeloma.
with support from:
Bristol Myers Squibb, Janssen, and Takeda Oncology