KEY TAKEAWAYS
- The CARTITUDE-2 phase 2 trial aimed to investigate the long-term efficacy and safety of cilta-cel in patients with R/R MM who received ≤3 prior lines of therapy.
- The primary endpoint was to determine MRD.
- Researchers noticed that Cilta-cel demonstrates long-term efficacy and safety in patients with MM, which is crucial for nurse-managed care.
Ciltacabtagene autoleucel (cilta-cel) is a B-cell maturation antigen (BCMA)-targeting chimeric antigen receptor-T cell (CAR-T) therapy approved for adults with relapsed/refractory (R/R) multiple myeloma (MM) who received ≥4 prior lines of therapy (LOT). Previous data from CARTITUDE-2 (NCT04133636) cohorts A and B demonstrated the efficacy and safety of cilta-cel for patients with MM in earlier LOT; understanding the long-term efficacy and safety of cilta-cel is important for nurses.
Tina Glow and the team aimed to assess the updated efficacy and safety data for CARTITUDE-2 cohorts A and B.
They performed an inclusive analysis where all patients received a single cilta-cel infusion and were naive to CAR-T and/or anti-BCMA therapies. Cohort A consisted of patients with lenalidomide-refractory MM who had undergone 1 to 3 prior lines of therapy (LOT), while Cohort B comprised patients with MM experiencing early relapse following initial therapy (≤12 months after the start of prior LOT or autologous stem cell transplant).
The primary endpoint for both cohorts was minimal residual disease (MRD) negativity, assessed at a threshold of 10-5 by next-generation sequencing or next-generation flow cytometry. Adverse events (AEs) were evaluated using NCI-CTCAE v5.0, with cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS) graded per ASTCT criteria.
After a median follow-up (MFU) of 29.9 months for cohort A (n=20) and 27.9 months for cohort B (n=19), MRD negativity was achieved in 17 (100%) of evaluable patients in cohort A and 14 (93%) in cohort B. Overall response rates (ORR) were 95% (complete response or better, [≥CR], 90%), and 100% (≥CR, 90%), respectively.
Hematological AEs included neutropenia (cohort A, 95%; cohort B, 95%), lymphopenia (cohort A, 80%; cohort B, 47%), thrombocytopenia (cohort A, 80%; cohort B, 58%), anemia (cohort A, 75%; cohort B, 58%), and leukopenia (cohort A, 60%; cohort B, 32%). Neurotoxicities were reported in both cohort A (n=3) and B (n=5). Secondary primary malignancy (SPM) occurred in cohort A (n=1).
In cohort B, 2 SPMs occurred, and 1 patient experienced movement/neurocognitive treatment-emergent AEs. There were 5 total deaths in Cohort A and 4 in Cohort B.
The study concluded that cilta-cel demonstrated deep responses and a manageable safety profile in patients with lenalidomide-refractory MM in earlier lines of therapy (cohort A) and those with early relapse (cohort B). These findings underscore its long-term efficacy and safety, highlighting essential considerations for oncology nurses in managing patient care and safety throughout cilta-cel administration.
The trial was sponsored by Janssen Research & Development, LLC.
Source: https://ons.confex.com/ons/2024/meetingapp.cgi/Paper/15566
Clinical Trial: https://clinicaltrials.gov/study/NCT04133636
Glow T, Whittington S, Cohen A, et al. (2024). “CARTITUDE-2 Long-Term Efficacy and Safety of Ciltacabtagene Autoleucel for Patients With Multiple Myeloma and 1-3 Prior Lines of Therapy (Cohort A) and With Early Relapse (Cohort B).” Presented at ONS 2024 (Abstract I26).
