Large B-Cell Lymphoma Overall Survival, Progression-Free Survival Consistent With Yescarta in Real-World Setting

Overall outcomes, including overall survival (OS) and progression-free survival (PFS), were consistent with axicabtagene ciloleucel (Yescarta; Kite, a company from Gilead) in adults with relapsed or refractory large B-cell lymphoma (LBCL) in the real-world setting, regardless of race or ethnicity, according to an oral session during the 2022 American Society of Clinical Oncology Annual Meeting.

In October 2017, axicabtagene ciloleucel became the first chimeric antigen receptor (CAR) T-cell immunotherapy to be approved for relapsed or refractory LBCL in adults who previously received at least 2 lines of systemic treatment.

“The investigation of CAR T-cell therapy outcomes by race and ethnicity is important to the continued understanding of the impact of these innovative therapies, and an area in which there is a significant deficit in clinical trials and real-world studies published to date,” Frederick Locke, MD, co-leader of the Immuno-Oncology Program at Moffitt Cancer Center in Tampa, Florida, said in a statement. “The results of this analysis are encouraging in that [axicabtagene ciloleucel] was safe and effective regardless of race or ethnicity, and also warrant further investigation to understand the lower rate of response among Black or African American patients and the potential role of factors such as higher disease burden, disease biology and, importantly, differential access to care.”

Investigators enrolled a total of 1389 patients with LBCL who were treated with axicabtagene ciloleucel in the commercial setting in the United States from October 2017 to August 2020.

The patient population was 81% white, 5% Black, 6% Asian, and fewer than 1% Native American, Alaska Native, Native Hawaiian, or other Pacific Islander. Additionally, fewer than 1% reported more than 1 race and 7% did not report race. Approximately 11% of patients self-identified as Hispanic or Latino.

At a median follow up of 12.7 months, the objective response rate were 57% for Black individuals, 67% for Asian individuals, 74% for white individuals and 73% for Hispanic or Latino individuals. Additionally, the PFS at 12 months was 46%, 55%, 48%, and 50%, respectively, and the OS at 12 months was 62%, 65%, 63%, and 65%, respectively.

Further, the complete response was 45% for Black individuals, 53% for Asian individuals, 57% for white individuals, and 55% for Hispanic and Latino individuals. The duration of response at 6 months was 66%, 81%, 70%, and 71%, respectively.

Black individuals were more likely to have moderate to severe pulmonary impairment and tended to have a longer time from diagnosis to infusion of axicabtagene ciloleucel compared to white individuals.

There were no observed differences in cytokine release syndrome by race and ethnicity. Furthermore, Asian individuals and Hispanic or Latino individuals had a lower risk of a grade 3 or greater immune effector cell-associated neurotoxicity syndrome.

Axicabtagene ciloleucel was also approved in April 2022 as the first CAR T-cell therapy for individuals with LBCL that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

The approval was based on results of the phase 3 ZUMA-7 trial (NCT03391466), which found that at a median follow-up of 24.9 months, estimated median event-free survival (EFS) was 8.3 months (95% CI, 4.5-15.8) with axi-cel compared with 2.0 months (95% CI, 1.6-2.8) with standard-of-care (SOC) treatment (HR, 0.4-; 95% CI, 0.31-0.51; P < .0001). Estimated 18-month EFS rates in the investigative and control cohorts were 41.5% (95% CI, 34.2%-48.6%) and 17.0% (95% CI, 11.8%-23.0%), respectively.

“As the global leader in CAR T-cell therapy, it is important to Kite that we support research to help better understand outcomes of CAR T-cell therapy across different races and ethnicities,” said Frank Neumann, MD, PhD, SVP and global head of Clinical Development, Kite, in a press release. “Through ongoing data generation, increasing diversity in Kite’s clinical trials, and partnerships with patient advocacy organizations and community partners to reduce barriers to care, we are actively working to increase our understanding of CAR T-cell therapy in diverse populations and treatment settings.”

Reference

Yescarta CAR T-cell therapy demonstrates consistent survival outcomes and safety in real-world setting regardless of race and ethnicity. Gilead. News release. June 3, 2022. Accessed June 4, 2022. https://www.gilead.com/news-and-press/press-room/press-releases/2022/6/yescarta-car-t-cell-therapy-demonstrates-consistent-survival-outcomes-and-safety-in-real-world-setting-regardless-of-race-and-ethnicity.