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According to data from the ZUMA-7 trial, the chimeric antigen receptor (CAR) T-cell therapy axicabtagene ciloleucel (axi-cel) led to significant and clinically meaningful improvement in event-free survival (EFS) compared with second-line standard of care in patients with relapsed or refractory large B-cell lymphoma (LBCL). The findings were presented by Frederick L. Locke, MD, of Moffit Cancer Center in Tampa, Florida, as a plenary abstract at the 2021 American Society of Hematology Annual Meeting.&ldquo;The results of ZUMA-7 herald a paradigm shift in how we treat large B-cell lymphoma,&rdquo; said Dr. Locke. The improvement in EFS &ldquo;is remarkable and indicates that patients with lymphoma not responding to initial treatment or relapsing within 12 months should have the opportunity to get this therapy.&rdquo;At a median follow-up of 24.9 months, axi-cel significantly improved EFS (hazard ratio [HR] = 0.398; p &lt; 0.0001), with a median EFS that was more than four times longer than EFS with standard-of-care chemoimmunotherapy (8.3 vs. 2.0 months). The 24-month EFS was more than twice as long (41% vs. 16%).In addition to the improvements in EFS, overall response rates (ORR) and complete response rates (CRR) were significantly higher with axi-cel compared with standard of care. ORR was 83% with axi-cel compared with 50% with standard of care (odds ratio [OR] = 5.31; p &lt; 0.0001). The CRR was more than twice as high with axi-cel (65% vs. 32%).Median overall survival was evaluated as a preplanned interim analysis. Overall survival favored axi-cel, but it did not meet statistical significance (not reached vs. 35.1 months; HR = 0.730; p = 0.027). The researchers noted that, among patients assigned to the standard-of-care arm, 56% received commercially available or investigational CAR T-cell therapy off-protocol as a subsequent therapy.The safety of axi-cel was manageable and consistent with third-line use, according to Dr. Locke. Most patients in both arms experienced treatment-emergent grade &ge;3 adverse events (AEs). In the axi-cel arm, grade &ge;3 cytokine release syndrome (CRS) occurred in 6% of patients, while grade &ge;3 neurologic events occurred in 21% of patients. No grade 5 CRS or neurological events occurred. &ldquo;For both study arms, the rates and types of adverse events were consistent with expectations based on previous trials and real-world experience,&rdquo; Dr. Locke noted.

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According to data from the ZUMA-7 trial, the chimeric antigen receptor (CAR) T-cell therapy axicabtagene ciloleucel (axi-cel) led to significant and clinically meaningful ...

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