Longer-Term Data for Axicabtagene Ciloleucel in Relapsed/Refractory Follicular Lymphoma Show Substantial Survival Improvement Over Current Therapies

Follow-up results from the ZUMA-5 trial of axicabtagene ciloleucel (Yescarta, Gilead), the first and only chimeric antigen receptor T-cell therapy approved in patients with relapsed or refractory indolent follicular lymphoma (FL), shows that 94% of patients had achieved a response, according to a Gilead press release.

In an analysis comparing ZUMA-5 patients with a minimum of 18 months follow-up with those observed in SCHOLAR-5, axicabtagene ciloleucel showed a superior overall survival (OS) and progression-free survival (PFS) over treatments that are currently available.

“Follicular lymphoma is one of the most common non-Hodgkin lymphomas, and patients can experience frequent relapses, which quickly leaves us short of treatment options,” said study author, professor John Gribben, in the press release. “We are very encouraged by these data that suggest a significant and sustained survival benefit with Yescarta even after multiple rounds of prior treatment.”

The score analysis compared follow-up data from the phase 2 ZUMA-5 study to a weighted sample from the SCHOLAR-5 external control cohort of current therapies balanced for patient characteristics through propensity scoring. In the ZUMA-5 cohort, 94% of patients achieved a response compared to 50% of patients in the control cohort with an odds ratio of 16.2.

Axicabtagene ciloleucel further demonstrated a 58% reduction in the risk of death and 70% reduction in the risk of disease progression, relapse, or death versus the current therapies in the control cohort, according to the study authors.

“In an indolent disease like follicular lymphoma, longer-term data that demonstrate durable responses are critical. After a patient with follicular lymphoma relapses, the duration of response shortens with each new therapy,” said Caron A. Jacobson, MD, MMSc, medical director, Immune Effector Cell Therapy Program, Dana-Farber Cancer Institute and Assistant professor of Medicine, Harvard Medical School, in the press release. “The continued durable benefit demonstrated by axicabtagene ciloleucel at nearly two years is exciting, and the substantial survival benefit over current therapies that we’re seeing in the SCHOLAR-5 analysis is encouraging. These follow-up data reinforce axicabtagene ciloleucel as an important advance for a group of patients who have historically had few options.”

Axicabtagene ciloleucel received accelerated approval from the FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy in March 2021.

REFERENCE

Longer-term Data for Kite’s Yescarta® in Relapsed or Refractory Follicular Lymphoma Demonstrate Substantial Survival Improvement Over Current Therapies in Comparative Analysis. Gilead. Published June 12, 2021. Accessed June 16, 2021. https://www.gilead.com/news-and-press/press-room/press-releases/2021/6/longer-term-data-for-kites-yescarta-in-relapsed-or-refractory-follicular-lymphoma-demonstrate-substantial-survival-improvement-over-current-therapie