Upgrade to SI Premium - Free Trial

Gilead's (GILD) Yescarta Shows Positive Results as a First-Line Treatment for Patients With High-Risk Large B-cell Lymphoma

December 7, 2020 6:35 AM

Kite, a Gilead Company (Nasdaq: GILD), today announced results from the interim analysis of ZUMA-12, a multicenter, open-label, single-arm Phase 2 study evaluating Yescarta® (axicabtagene ciloleucel) as first-line therapy in patients with high-risk large B-cell lymphoma (LBCL). After a single infusion of Yescarta, 85 percent of patients achieved a response (n=27 evaluable for efficacy), including 74 percent of patients with a complete response. The data were presented in an oral session during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract #405).

“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 S. Neelapu, MD, Professor, 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.”

Among evaluable patients with centrally confirmed high-risk LBCL with at least one month of follow-up (n=27), 85 percent of patients responded, including 74 percent with a complete response. With a median follow-up of 9.3 months, 70 percent of response-evaluable patients were in an ongoing response at data cut-off, per investigator assessment. Median progression-free survival, median overall survival and median duration of response were not reached after a median follow-up of 9.5 months.

Among all safety-evaluable patients who received any dose of Yescarta with at least one month of follow-up (n=32), Grade 3 or higher cytokine release syndrome (CRS) and neurologic events (NE) occurred in 9 percent and 25 percent of patients, respectively. No Grade 5 CRS or NEs occurred. There was one Grade 5 adverse event due to COVID-19.

“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, MD, Kite’s Global Head of Clinical Development. “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.”

Kite has presented four-year survival data for Yescarta in the ZUMA-1 study of patients with refractory large B-cell lymphoma. Based on these data and other data presented at ASH, Kite believes that Yescarta could bring the hope of survival to patients with a number of other hematological malignancies.

Yescarta was the first chimeric antigen receptor (CAR) T cell therapy to be approved by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including 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 FL. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of CRS and neurologic toxicities, and Yescarta is approved with a risk evaluation and mitigation strategy (REMS) due to these risks; see below for Important Safety Information.

Categories

Corporate News FDA

Next Articles