Tecartus for Mantle Cell Lymphoma Demonstrates Positive Data in Latest Study

Three-year follow-up analysis shows that Gilead’s car T-cell therapy induced high rates of durable response and a median overall survival of 46.6 months.

Kite, a Gilead Company, has released positive longer-term follow-up results from 2 pivotal studies of the CAR T-cell therapy Tecartus (brexucabtagene autoleucel).

The 3-year follow-up of ZUMA-2, a global, multi-center, phase 2 study evaluating the efficacy of Tecartus in patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL), and 2-year follow-up of ZUMA-3, a global, multi-center, open-label, single-arm phase 1/2 study evaluating Tecartus in adult patients with R/R B-cell acute lymphoblastic leukemia (B-ALL) were both presented during a poster session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Three-year follow-up data from ZUMA-2 were also simultaneously published in ASCO’s Journal of Clinical Oncology.

“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, MD, PhD, senior vice president and global head of clinical development at Kite said in a statement. “These longer-term results add to the growing maturity of data on Kite’s CAR T-cell therapies.”

At a median of 35.6 of follow-up in the ZUMA-2 trial, the overall response rate (ORR) was 91%, with 68% of treated patients achieving a complete response (CR; 95% CI, 55.2–78.5). The median duration of response (DOR) was 28.2 months, with 37% of treated patients in ongoing response at data cut-off. Median overall survival (OS) among treated patients was 46.6 months. Among those patients who achieved a CR, the median OS has not yet been reached, with the 30-month OS rate at 60.3%. Late relapse, classified as more than 24 months post-infusion, was infrequent (n=3).

“There remains a significant need among patients living with MCL for therapies that provide a long-term response, as many patients have high-risk disease that is more likely to relapse or progress following multiple lines of treatment,” Michael Wang, MD, ZUMA-2 Lead Investigator and Puddin Clarke Endowed Professor, Department of Lymphoma and Myeloma, division of cancer medicine at The University of Texas MD Anderson Cancer Center, said in the statement. “The 3-year data from ZUMA-2 represent the longest follow-up for a CAR T-cell therapy in MCL patients to date and are impressive in their demonstration of brexu-cel to elicit durable long-term responses.”

In the ZUMA-3 trial, longer follow-up of the pivotal analysis and outcomes of a newly conducted larger pooled analysis of phase 1 and 2 patients by independent review who received the pivotal dose of Tecartus were reported. Most patients in the analysis were heavily pre-treated, with a median of 2 prior therapies, and 47% had received 3 or more prior therapies. At a median follow-up of 29.7 months for pooled phase 1 and 2 patients, 73.1% of treated patients achieved a CR or CR with incomplete hematological recovery (CRi). Median OS was 25.4 months for both phase 2-treated patients and pooled phase 1 and 2 treated patients. At data cutoff, median OS had not yet been reached in phase 2 patients who achieved a CR. Similar outcomes among phase 2 treated patients (n=55) and the pooled analysis of phase 1 and 2 patients (n=78) were observed.

Reference

Tecartus® Car T-cell therapy demonstrates strong overall survival rates and continued durable responses in long-term follow-up of two pivotal studies including longest ever follow-up of a CAR T-cell therapy in mantle cell lymphoma. Gilead. News release. June 4, 2022. Accessed June 5, 2022. https://www.gilead.com/news-and-press/press-room/press-releases/2022/6/tecartus-car-t-cell-therapy-demonstrates-strong-overall-survival-rates-and-continued-durable-responses-in-long-term-follow-up-of-two-pivotal-studies