KEY TAKEAWAYS
- The CARTITUDE-2 study evaluated the identification and management of AEs associated with administering cilta-cel in MM patients.
- The safety features of cilta-cel were manageable and consistent across the different patient cohorts.
- Nurses were recognized as crucial in identifying and managing adverse events and providing information about cilta-cel to patients.
In the CARTITUDE-2 study, patients (pts) with multiple myeloma (MM) were administered a single ciltacabtagene autoleucel (cilta-cel) infusion. Cohort A consisted of pts who had undergone 1 to 3 prior lines of therapy (LOT), a proteasome inhibitor (PI), and an immunomodulatory drug (IMiD) but demonstrated resistance to lenalidomide. Cohort B comprised pts who experienced early disease progression (within ≤12 mo after autologous stem cell transplant or the beginning of prior LOT) after initial treatment, including a PI and an IMiD. Both Cohorts A and B were not exposed to previous anti-BCMA treatments. Cohort C consisted of pts previously receiving a PI, an IMiD, an anti-CD38 antibody, and a BCMA-targeting antibody-drug conjugate or bispecific antibody. The evaluation of the incidence and severity of adverse events (AEs) were done per CTCAE v5.0 criteria, with cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS) graded as per ASTCT criteria.
In Cohort A, the median duration of follow-up was 17.1 mo (ranging from 3.3 to 23.1, with 20 pts); Cohort B had a follow-up duration of 18.0 mo (ranging from 5.2 to 26.3, including 19 pts); and Cohort C had a follow-up duration of 18.0 mo (ranging from 0.6 to 22.7, with 20 pts). The overall response rates were 95% for Cohort A, 100% for Cohort B, and 60% for Cohort C. The most frequently observed AEs included cytopenias, with most cases improving to grade ≤2 by day 60 across all groups. The timing and duration of CRS and ICANS were comparable among the different cohorts. CRS was controlled using tocilizumab, corticosteroids, anakinra, or supportive measures. Most ICANS cases were of ≤grade 2 severity and were primarily treated with corticosteroids per the prescribed management guidelines. The incidence of movement and neurocognitive treatment-related AEs within the CARTITUDE program has been reduced to less than 0.5% through patient-management techniques (including one new case observed in Cohort B, despite more than 250 pts being treated).
The safety features of cilta-cel were manageable and consistent across various groups, highlighting the need for additional exploration of cilta-cel’s potential within these specific patient groups. Nurses played a pivotal role in recognizing and effectively handling AEs and providing comprehensive information about cilta-cel to the pts.
Source: https://ons.confex.com/ons/2023/meetingapp.cgi/Paper/13551
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04133636
Steinbach, M., Jackso, C., Suarez, J., Pacaud, L., Riccobono, C., Aronson, E.
