– First CAR T-Cell Therapy to Report First-Line Data in LBCL –

SANTA MONICA, Calif.–(BUSINESS WIRE)– Kite, a Gilead Company (NASDAQ:GILD), today announced primary results from ZUMA-12, a global,

– First CAR T-Cell Therapy to Report First-Line Data in LBCL –

SANTA MONICA, Calif.–(BUSINESS WIRE)– Kite, a Gilead Company (NASDAQ:GILD), today announced primary results from ZUMA-12, a global, multicenter, single-arm, open-label Phase 2 study evaluating Yescarta® (axicabtagene ciloleucel) as part of first-line treatment in patients with high-risk large B-cell lymphoma (LBCL). This is the first study to evaluate CAR T-cell therapy as part of first-line therapy in high-risk LBCL. The study is based on the desire to utilize potential curative treatment as quickly as possible and the hypothesis that earlier use of CAR T-cell therapy when T cells are healthier may produce better outcomes. The data were presented in an oral session during the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract #739).

After a single infusion of Yescarta, 89% of evaluable patients achieved a response (ORR) (n=37 evaluable for efficacy), including 78% of patients with a complete response (CR) at a median follow-up of 15.9 months. CR rate was consistent among key subgroups. Among evaluable patients, median time to response was one month. At time of data cut-off, 73% of evaluable patients had ongoing responses. Medians for duration of response (DOR), event-free survival (EFS), and progression-free survival (PFS) were not yet reached, with 12-month estimates of 81%, 73%, and 75%, respectively, and an estimated 12-month OS rate of 91%.

Yescarta was successfully manufactured for all 42 enrolled patients with a median turnaround time of 18 days between leukapheresis and delivery to the trial site for treated patients. Levels of CCR7+CD45RA+ T cells (a measure of T-cell fitness) found in pre-infused product were more than double what was measured in the heavily pre-treated third line ZUMA-1 patient population. Levels of CCR7+CD45RA+ T cells in pre-infused product have been associated with a favorable pharmacokinetic (PK) profile. CAR T-cell expansion also appeared greater in ZUMA-12 compared with ZUMA-1.

“Less than half of patients with high-risk LBCL actually achieve long-term remission with standard first-line therapy,” said Sattva S. Neelapu, MD, Professor, Department of Lymphoma-Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. “There have been a number of attempts to improve outcomes for high-risk patients, either by intensification of chemotherapy, immunotherapy, or consolidation with autologous stem cell transplantation, but they have not been successful. The impressive response rates in ZUMA-12 support the potential of CAR T-cell therapy earlier in treatment to improve outcomes in these high-risk patients.”

Among all treated patients (n=40), safety observations were consistent with the known safety profile for Yescarta. Grade 3 cytokine release syndrome (CRS) occurred in (8%) of patients and Grade ≥3 neurologic events occurred in (23%) of patients. No Grade 5 CRS or neurological events occurred. There was one Grade 5 adverse event due to COVID-19. All CRS cases and most neurologic events (28/29) of any grade resolved by the time of data cut-off.

“The high rate of durable response to a one-time infusion of Yescarta in newly diagnosed patients with high-risk LBCL is exceptional,” said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development. “Many of these patients typically progress very quickly on current standard-of-care therapies. Further study is needed to understand Yescarta’s potential as first-line therapy, but we are encouraged by these results.”

Yescarta has not been approved by any regulatory agency for the treatment of patients in the first-line setting. See About Yescarta section for current Yescarta approved indications.