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• W2912192685 abstract "The FDA approval of the anti-CD19 chimeric antigen receptor (CAR) T-cell product axicabtagene ciloleucel (axi-cel, YESCARTA®) was based on ZUMA-1 (NCT 02348216), a multi-center phase 2 trial of 111 patients with relapsed/refractory large cell lymphoma (Neelapu et al. NEJM 2017). Without a standardized reimbursement pathway, the complex workflow of axi-cel may increase delays in care for patients who are otherwise eligible for treatment. We hypothesized that the time to treatment, and probability of receiving treatment with commercial axi-cel, would be inferior to our experience on ZUMA-1 and lead to adverse patient outcomes. From Jan 2016 to Feb 2017, we enrolled 5 patients on ZUMA-1. Using similar eligibility criteria, we intended to treat 25 patients with commercial axi-cel from Nov 2017 to Aug 2018. Time-to-treatment was calculated from date of informed consent (ZUMA-1) or from insurance verification (non-trial patients) and ended at infusion. Time-to-treatment was significantly shorter for ZUMA-1 compared to non-trial patients (mean 31.8 days vs 77.5 days, P:0.003). ZUMA-1 patients were older (mean 64.8 vs. 56.0 years, P:ns), received more lines of chemotherapy prior to initiating the approval process (4.4 vs. 3.3 lines, P:ns), and had a larger volume of disease (largest lesion 36 cm2vs 16.4cm2, P:ns). The majority of non-trial patients (6/8) received bridging chemotherapy (0-2 lines), and there were 5 hospitalizations totaling 27 days. Steroid use was similar between groups (40.0% vs 37.5%) and more non-trial patients received tocilizumab (40.0% vs 62.5%, P=ns), possibly due to updated toxicity guidelines. In the non-trial group, 10 patients became ineligible due to death (6), transfer to another institution (2), clinical decline (1), and loss of follow-up (1) with a mean time to ineligibility of 54.8 days (range 9-91 days). Seven eligible patients are awaiting reimbursement approval (mean 47.3 days, range 5-166 days). ZUMA-1 outcomes were superior to commercial patients with all 5 patients achieving a response by day 30 and all 3 initial partial responses (PRs) deepening to a complete response (CR). In the non-trial group, there were 3 CRs, 2 PRs, 1 stable disease, and 2 patients with disease progression at/before day 30. All ZUMA-1 patients are alive after a median of 721 days vs 7/8 axi-cel patients (median follow-up 78.5 days). In our non-trial experience, treatment with axi-cel resulted in a superior overall survival compared to being untreated (not reached vs 61 days, P:0.01). This single-center experience highlights the ongoing challenges with axi-cel in the real world setting compared with the experience on ZUMA-1, including delays in insurance approval, use of bridging chemotherapy, added chemotherapy toxicity, and increased mortality while awaiting treatment. Standardized reimbursement pathways are needed to ensure timely access to these therapies." @default.
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• W2912192685 date "2019-03-01" @default.
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• W2912192685 title "Commercial Chimeric Antigen Receptor (CAR) T Cells: Unfamiliar Roads and Stalled Cars" @default.
• W2912192685 doi "https://doi.org/10.1016/j.bbmt.2018.12.653" @default.
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