Gilead’s CAR T therapy Yescarta shows potential in new indication

Gilead’s Yescarta has scored some promising interim results from a phase II study evaluating the chimeric antigen receptor (CAR) T therapy as a first-line treatment for high-risk large B-cell lymphoma (LBCL) patients.

In an interim analysis of the ZUMA-12 phase II study, 85% of LBCL patients achieved a response following treatment with Yescarta (axicabtagene ciloleucel), with 74% of patients achieving a complete response.

Following a median follow-up of 9.3 months, 70% of response-evaluable patients were in an ongoing response at data cut-off. Median progression-free survival, median overall survival and median duration of response were not reached after a median follow-up of 9.5 months.

“Yescarta has already presented four-year survival data in patients with third-line refractory LBCL and we are now excited for what these ZUMA-12 results signal for its potential in earlier lines of treatment,” said Ken Takeshita, global head of clinical development, Kite, a Gilead company.

“As the first positive results for a CAR T as a first-line therapy, these data are a tremendous step forward as we work to bring the benefits of Yescarta to more patients with this disease,” he added.

Yescarta was the first CAR T therapy to win approval from the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy.

This approval also included Yescarta treatment for diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), and high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma (FL).

“Despite well-established standard treatment regimens in newly diagnosed large B-cell lymphoma, patients with high-risk disease are underserved by currently available treatment options,” said Sattva Neelapu, professor at the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center.

“Only half of these patients achieve long-term remission with standard first-line therapy, so there is a major need for therapies with potential to improve outcomes for more patients. These early results from the ZUMA-12 trial are highly encouraging for the potential of CAR T in this earlier setting in patients with high risk,” he added.