Kite's CAR-T Therapy Yescarta Demonstrates Superiority Over Standard of Care in Second-Line Treatment of Relapsed/Refractory Large B-Cell Lymphoma

On June 28, Kite Pharma, a Gilead Sciences company, announced that its CAR-T cell therapy Yescarta (axicabtagene ciloleucel) achieved positive top-line results in a Phase 3 clinical trial evaluating its use as a second-line therapy for patients with relapsed/refractory large B-cell lymphoma (LBCL). The trial met the primary endpoint of event-free survival (EFS) (HR=0.398, p <0.0001) and the key secondary endpoint of objective response rate (ORR). At a median follow-up of 2 years, the treatment demonstrated a highly statistically and clinically significant improvement compared to standard of care (SOC). An interim analysis of overall survival (OS) in the Yescarta arm showed a favorable trend; however, the data remain immature.

Approximately 40% of patients with relapsed/refractory large B-cell lymphoma will require second-line therapy, as their cancer may relapse or be unresponsive to standard treatment. The press release noted that these trial results could change the second-line treatment paradigm for these patients.

Regarding safety, the safety results of the trial were consistent with or lower than the known safety profile of Yescarta in third-line LBCL treatment, and no new safety concerns were identified in this second-line treatment trial. Grade 3 or higher cytokine release syndrome (CRS) occurred in 6% of patients, and grade 3 or higher neurologic events occurred in 21% of patients.

ZUMA-7 is a randomized, double-blind, open-label, multicenter, global Phase 3 clinical trial that evaluated the safety and efficacy of second-line Yescarta compared with the current standard of care in adult patients with relapsed/refractory large B-cell lymphoma within 12 months of first-line therapy. The current standard of care for second-line treatment consists of a two-step process: reintroduction of chemoimmunotherapy, and if patients respond and can tolerate further treatment, proceeding to high-dose chemotherapy plus stem cell transplantation.

A total of 359 patients were enrolled in the trial, aged 22 to 81 years, with 30% aged ≥65 years. Patients were randomized 1:1 to receive a single infusion of Yescarta or standard therapy as second-line treatment. The primary endpoint was event-free survival (EFS), defined as the time from randomization to the earliest occurrence of disease progression according to the Lugano Classification, initiation of new lymphoma therapy, or death. Key secondary endpoints included overall response rate (ORR) and overall survival (OS).

Note: The original text has been abridged.

References:

[1] Kite Announces Yescarta® Car T-Cell Therapy Improved Event-Free Survival By 60% Over Chemotherapy Plus Stem Cell Transplant In Second-Line Relapsed Or Refractory Large B-Cell Lymphoma. Retrieved June 28, 2021, from https://www.kitepharma.com/news/press-releases/2021/6/kite-announces-yescarta-car-tcell-therapy-improved-eventfree-survival-by-60-over-chemotherapy-plus-stem-cell-transplant-in-secondline-relapsed-or

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