ZUMA-1 Study of Yescarta Reports 58% Complete Remission

Long-term data presented at the American Society of Hematology Annual Meeting. 

Kite, a Gilead company, recently announced long-term follow-up data from its pivotal Zuma-1 study of Yescarta™ (axicabtagene ciloleucel). According to Kite, following up after a year (minimum) from a single infusion of Yescarta (median follow-up of 15.4 months), 42% of patients expressed a continued response to therapy, including 40% experiencing complete remission.

Detailed results from the updated analysis were presented at the Annual Meeting of the American Society of Hematology (ASH) in Atlanta, which coincided with its publishing in The New England Journal of Medicine noted Kite.

Yescarta, explained the company, is the first approved CAR-T therapy to treat diffuse large B-cell lymphomas (DLBCL), therapy intended for patients who do not demonstrate progress from two rounds of systemic chemotherapy.

Sattva S. Neelapu, MD, ZUMA-1 Co-Lead Investigator and Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center observed, “In the SCHOLAR-1 study, treatment options for patients with refractory large B-cell lymphoma … yielded a median overall survival of just six months, with fewer than 10% of patients achieving complete remission. The durability of response seen with Yescarta in this long-term follow-up,” said Neelapu, “reinforces the major advance that CAR T therapy represents for these patients.”

Kite’s intention was to evaluate the durability of the patient response after a minimum of one year from the date of treatment during the ZUMA-1 trial. In Kite’s updated analysis, 82% of patients had responded to Yescarta—that also included 58% who had experienced complete remission.

“At a median of 15.4 months post-infusion,” said Kite, “42% of patients remained in response, including 40% in complete remission,” with the median of the response’s duration 11.1 months, in patients, said Kite achieving complete remission.

“Historically,” said David Chang, Kite’s Worldwide Head of Research and Development and Chief Medical Officer, “people with refractory large B-cell lymphoma have not been adequately served by available treatment options.” Chang remarked that Kite is encouraged by the durability and depth of response after treatment with Yescarta, “which represents an important advance in the treatment of patients with refractory disease,” he added Chang.

 

Nice Insight

Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.

Q: