Saad Usmani, FACP, MBA, MD from the Department of Hematologic Oncology and Blood Disorders, Atrium Health"™s Levine Cancer Institute speaks about the ASCO 2021 Abstract – Comparison of outcomes with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 versus real-world standard of care (RW SOC) for patients (pts) with triple-class exposed relapsed/refractory multiple myeloma (RRMM).
Link to Abstract –
https://meetings.asco.org/abstracts-presentations/195465
Background information:
Patients with RRMM that are triple-class exposed (to immunomodulatory medications [IMiDs], proteasome inhibitors [PIs], and an anti-CD38 antibody) go on several salvage regimens, each with increasingly worse outcomes. CARTITUDE-1 (NCT03548207) is a single-arm phase 1b/2 study evaluating cilta-cel, a chimeric antigen receptor T-cell therapy with two B-cell maturation antigen"“targeting single-domain antibodies, in patients with RRMM who had previously received three lines of therapy (LOT) or were double refractory to an IMiD and PI, were triple-class exposed, had an ECOG score of 0 In this study, we compare the efficacy outcomes of patients who received cilta-cel in CARTITUDE-1 (N = 97) versus patients who received SOC in a synthetic cohort from RW clinical practice.
Methodologies:
The Flatiron database (Sep 2020 data cutoff), which is essentially a US community-based MM register, was used to classify a RW pt cohort that met CARTITUDE-1 eligibility requirements, including organ activity. Using inverse likelihood of therapy (tx) weighting (IPTW) propensity scores adjusted for unbalanced baseline covariates of prognostic importance, progression-free/overall survival (PFS/OS) was matched between the cilta-cel"“treated US pts and the RW SOC cohort. Multivariate Cox regression models and propensity score matching were used to conduct sensitivity analyses.
The below are the outcomes:
After likelihood score weighting, the baseline features of the two populations were identical (Table). Pomalidomide (33 percent), carfilzomib (32 percent), daratumumab (13 percent), elotuzumab (16 percent), and ixazomib (16 percent) were the most popular SOC tx regimens in the RW cohort (8 percent ). Pts had a better PFS and OS with cilta-cel (N = 97; median follow-up 12.4 mo) vs RW SOC (N = 196; median follow-up 9.2 mo), with an 84 percent and 78 percent decrease in the chance of progression/cancer and death, respectively (Table). The value of cilta-cel therapy was consistent through sensitivity analyses.
Final Thoughts:
Cilta-cel outperforms RW SOC in terms of PFS and OS, indicating that it may be a viable treatment choice for patients with triple-class exposed RRMM. NCT03548207 is the number for the clinical trial.