Real World Study Demonstrates Consistent Survival for Gilead’s Yescarta Across Race/Ethnicity

California-based Kite, a Gilead company, announced results from the post-authorization retrospective, real-world analysis of Yescarta (axicabtagene ciloleucel), its CAR T-cell therapy for relapsed or refractory large B-cell lymphoma (LBCL). The study revealed that Yescarta was both safe and effective in adult patients regardless of race and ethnicity.

The findings, presented during an oral session at the 2022 American Society of Clinical Oncology (ASCO), showed a 12-month overall survival rate of 62% among Black or African American patients, 65% among Asians and 65% among those who identified as Hispanic or Latino. White patients, in comparison, saw a 63% overall survival after 1 year.

Yescarta’s progression-free survival was likewise comparable across different races and ethnicities, with rates ranging from 36% to 55%. Generally, the drug’s safety profile also did not differ according to race and ethnicity.

However, while overall efficacy and safety were consistent across race and ethnicity, Black or African American patients tended to endure a longer wait from diagnosis to Yescarta infusion. This could have, in turn, negatively affected their response rates, which were found to be lower than in white patients.

“The results of this analysis are encouraging in that axi-cel 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,” Frederick L. Locke, M.D., lead author of the study and co-leader of the immune-oncology program at Moffitt Cancer Center, Tampa, Florida, said in a statement.

The post-authorization study assessed 1,389 adult LBCL patients who had been treated with Yescarta from October 2017 to August 2022. White patients comprised a majority of the participants, while only 5% identified as Black or African American. Patient data were retrieved from the Center for International Blood and Marrow Transplant Research.

On average, clinical trials of Yescarta in the United States enroll around 6% Black or African Americans. Meanwhile, diffuse LBCL has an incidence of 4.8 per 100,000 cases per year in this patient population, as compared with 7.1 per 100,000 per year in non-Hispanic whites. Current enrollment figures are not enough to determine whether trials are being sufficiently inclusive as regards race and ethnicity, and more studies are needed to accurately evaluate representation and diversity in CAR T-cell therapy literature.

Kite continued to impress elsewhere at ASCO and announced that Tecartus, another CAR T-cell therapy, is highly effective in the long run for adults with relapsed/refractory mantle cell lymphoma (MCL) or B-cell acute lymphoblastic leukemia (B-ALL).

Long-term follow-up of the pivotal ZUMA-2 and ZUMA-3 trials showed strong durability of response with Tecartus. In patients who achieved complete response, median overall survival has not yet been reached. There were also no new safety signals recorded during the extended follow-up period.

“We are very encouraged by the totality of these data, which suggest a significant and sustained response with Tecartus for people living with difficult-to-treat blood cancers like MCL and B-ALL,” Frank Neumann, M.D., Ph.D., senior vice president and global head of Clinical Development at Kite, said.

“These longer-term results add to the growing maturity of data on Kite’s CAR T-cell therapies.”