In March 2021, the U.S. Food and Drug Administration granted accelerated approval to axicabtagene ciloleucel, a CD19-directed chimeric antigen receptor T-cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after at least 2 lines of systemic therapy. Approval was based on ZUMA-5, a single-arm, open-label, multicenter trial that evaluated a single infusion of axicabtagene ciloleucel, preceded by lymphodepleting chemotherapy with cyclophosphamide and fludarabine, in this population. Efficacy was based on objective response rate (ORR) and duration of response (DOR) as determined by an independent review committee. Among 81 patients in the primary efficacy analysis, having a median of 3 (range 2-9) prior lines of systemic therapy, the ORR was 91% (95% confidence interval [CI]: 83-96) with a complete remission (CR) rate of 60% and a median time-to-response of 1 month. The median DOR was not reached, and the 1-year rate of continued remission was 76% (95% CI: 64-85). For all leukapheresed patients with FL in this trial (n = 123), the ORR was 89% (95% CI: 83-94) with a CR rate of 62%. Among 146 patients with indolent lymphoma evaluated for safety, cytokine release syndrome occurred in 84% (Grade ≥3, 8%) and neurological toxicities occurred in 77% (Grade ≥3, 21%), leading to implementation of a risk evaluation and mitigation strategy. Serious adverse reactions occurred in 48%. Post-marketing studies will further evaluate clinical benefit in patients with r/r FL and long-term safety.
This report details the third annual, full-day workshop exploring the state-of-practice in the metrology necessary for repeatably and independently assessing the performance of robotic systems in real-world human-robot interaction (HRI) scenarios. This workshop continues the aims of shortening the lead time between the theory and applications of HRI, enabling reproducible studies, and accelerating the adoption of cutting-edge technologies as the industry state-of-practice. The workshop was held on March 12, 2021, as part of the virtual ACM/IEEE International Conference on Human-Robot Interaction.This third installment of the annual workshop, 'Test Methods and Metrics for Effective HRI,' seeks to identify novel and emerging test methods and metrics for the holistic assessment and assurance of HRI performance. The focus is on identifying innovative metrics and test methods for the evaluation of HRI performance, and to advance the growth of the HRI community based on the principles of collaboration, data sharing, and repeatability. The goal of this workshop is to aid in the advancement of HRI technologies through the development of experimental design, test methods, and metrics for assessing interaction and interface designs.
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