Latest Insights from CARTITUDE-2 Trial on Ciltacabtagene Autoleucel in Multiple Myeloma — Cohort A and Early Relapse (Cohort B) Updates  

Dr. Jens Hillengass presents results of the phase II CARTITUDE-2 Trial, including updated efficacy and safety data from the trial’s cohorts A and B, both with a median follow-up of ~29 months. 

Abstract title:

The Phase II CARTITUDE-2 Trial: Updated Efficacy and Safety of Ciltacabtagene Autoleucel in Patients with Multiple Myeloma and 1–3 Prior Lines of Therapy (Cohort A) and with Early Relapse after First Line Treatment (Cohort B) Presented at ASH 2023   

What is the purpose of this trial?  

The CARTITUDE-2 trial (NCT04133636) aims to assess the safety and effectiveness of ciltacabtagene autoleucel (cilta-cel), a novel anti-BCMA chimeric antigen receptor (CAR)-T cell therapy, in different groups of patients with multiple myeloma (MM). The study focuses on patients who have received 1–3 prior lines of therapy (LOT) and are refractory to Revlimid (lenalidomide, or len) in cohort A, as well as those experiencing early relapse (≤12 months after autologous stem cell transplant [ASCT] or the start of initial anti-myeloma treatment) in cohort B. 

Previously reported results covered a 17-month median follow-up for cohort A and an 18-month median follow-up for cohort B. The trial explores the extended efficacy and safety of cilta-cel with an updated median follow-up of approximately 29 months.  

Furthermore, the CARTITUDE-4 study is evaluating cilta-cel in patients with lenalidomide-refractory multiple myeloma after 1–3 prior treatments, which has demonstrated promising results in prolonging progression-free survival compared to the standard of care. 

This trial contributes crucial insights into the long-term outcomes and safety profile of cilta-cel across different patient populations. 

In this video: 

Jens Hillengass, MD, PhD, (Roswell Park Comprehensive Cancer Center — Buffalo, NY) discusses the results of the phase II CARTITUDE-2 trial, which studies the safety and effectiveness of ciltacabtagene autoleucel (cilta-cel) in both early relapse myeloma patients, and myeloma patients who have received 1-3 prior lines of treatment and are refractory to Revlimid (lenalidomide). 

Trial information: Abstract #1021 (https://ash.confex.com/ash/2023/webprogram/Paper178882.html) 

Conclusion: 

In this trial, patients with multiple myeloma who received ciltacabtagene autoleucel (cilta-cel) in earlier lines of therapy (cohort A) and those with early relapse (cohort B) showed deep and lasting responses to treatment during longer-term follow-up. The data revealed no new safety concerns related to CAR-T cell therapy, except for one additional case of neurotoxicity in cohort B. 

For cohort A, the findings provide insights into potential longer-term survival outcomes, offering valuable information for the ongoing phase 3 CARTITUDE-4 trial, which includes a similar patient population but has a shorter follow-up period so far. The data from cohort B emphasize the enduring effectiveness of cilta-cel in patients experiencing early relapse, a population with high-functional risk where standard risk factors may not accurately predict the risk of relapse. This highlights the significant unmet need in this group of patients, and cilta-cel appears to be a promising therapeutic option for addressing this challenge. 

Doctor bio: 

Jens Hillengass, MD, PhD, is a Professor of Oncology Internal Medicine and the Chief of Myeloma at Roswell Comprehensive Cancer Center in Buffalo, NY. Dr. An expert in diagnostics and treatment of monoclonal plasma-cell disorders, autologous stem-cell transplantation and hemato-oncological imaging, his special interests include early detection and characterization of monoclonal plasma cell disorders, and imaging of bone or bone-marrow involvement in monoclonal plasma-cell diseases. 

Dr. Hillengass is board-certified in internal medicine and hematology/oncology. He earned his medical degree from the University of Heidelberg and went on to complete fellowships in hematology/oncology, at the University hospital of Heidelberg; radiology, at the German Cancer Research Center; and as a visiting researcher at the National Cancer Institute. 

He has authored or co-authored over 115 peer-reviewed publications and has been principal investigator or co-investigator on many clinical trials.