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Introduction: Hypoalbuminemia is a known adverse prognostic factor in lymphomas. Yet, it is unknown if axicabtagene ciloleucel (axi‐cel) overcomes the adverse prognostic impact of hypoalbuminemia in relapsed/refractory large B‐cell lymphoma. Methods: We conducted a retrospective analysis across three Mayo Clinic centers to assess the relationship of hypoalbuminemia (defined as a serum albumin (SA) levels ≤ 3.5 g/dL) on outcomes of patients treated with axi‐cel. Results: This analysis included 81 patients. Two patients had no available SA levels preceding axi‐cel infusion. Eighteen patients (22.8%) had hypoalbuminemia with a median SA of 3.3 g/dL. Patients with normal SA had a statistically higher ORR than those without hypoalbuminemia (P =.018). There was no difference in 1‐year PFS and OS between the group with hypoalbuminemia and the group with normal SA levels (48% vs 49%, P =.81) and (74% vs 73%, P =.97), respectively. There was no difference in the severity or median duration of cytokine release syndrome or neurotoxicity between the two groups. Conclusion: Notwithstanding the limitations related to the relatively small sample size, axi‐cel therapy appears to overcome the adverse effect of hypoalbuminemia on OS and PFS. Large multicenter clinical studies are certainly needed to validate these findings. [ABSTRACT FROM AUTHOR]

Axi-cel is an autologous anti-CD19 chimeric antigen receptor T-cell therapy approved for treatment of CD19+ relapsed/refractory large B-cell lymphoma. Axi-cel is associated with unique toxicities, namely cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Our understanding of these toxicities continues to evolve and identification of predictive biomarkers is essential to optimize management strategies for such toxicities. Albumin is a known inflammatory marker; however, its relation to axi-cel toxicities remains unclear. We conduct this analysis to assess the significance of a decrease in serum albumin levels and its relation to ICANS. We conducted a retrospective analysis of all patients treated with axi-cel across the 3 Mayo Clinic campuses (Rochester, Jacksonville, and Phoenix) from 06/01/2018 until 06/01/2019. Albumin levels were collected at baseline (within 5 days prior to axi-cel infusion), time of CRS onset, time of ICANS onset and at Day +30. A total of 54 patients (male=39, 72%) with a median age of 53 (26-67) years received axi-cel during the study period. Median number of prior lines of therapy was 3 (2-8). Number of patients who developed ICANS was 33 (61%) patients; 4 patients did not have serum albumin levels available at all specified time points, therefore, 29 patients constituted the study cohort (patient characteristics are shown in Table 1, no statistically significant difference was noted between groups). Of patients who developed ICANS, 7 patients (24%) had low serum albumin (< 3.5 g/dL) at baseline. Twenty three patients (80%) had a decrease in serum albumin at onset of ICANS with a median decrease from baseline of 0.8 g/dL (range: 0.1-1.3), representing a median percentage decrease from baseline of 19% (2%-36%) (Figure 1). Recovery of serum albumin to a normal range at day +30 was observed in 21 (72%) patients with a median increase in serum albumin level of 0.7 g/dL (0.2-2.3). The magnitude of this decrease was not observed with onset of CRS or in patients with only CRS (without ICANS). A decrease in serum albumin level appears to serve as a predictive marker of ICANS onset and a subsequent increase appears to herald its resolution. If validated in larger studies, use of serum albumin could potentially serve as a cost-effective method compared to more expensive currently used serum markers. [ABSTRACT FROM AUTHOR]