Kite Announces Yescarta® CAR T-cell Therapy Improved Event-Free Survival by 60% Over Chemotherapy Plus Stem Cell Transplant in Second-Line Relapsed or Refractory Large B-cell Lymphoma

--  Landmark ZUMA-7 Study was Initiated in 2017 as the First Randomized Clinical Trial to Test the Earlier Use of a CAR T-cell Therapy Against Standard of Care --

-- Study Met the Primary and Key Secondary Endpoints of Event-Free Survival and Objective Response Rate, Demonstrating a Highly Statistically and Clinically Significant Improvement Compared to Standard of Care --

SANTA MONICA, CA, USA I June 28, 2021 I Kite, a Gilead Company (Nasdaq: GILD), today announced top-line results from the primary analysis of ZUMA-7, a randomized Phase 3 global, multicenter study showing superiority of Yescarta® (axicabtagene ciloleucel) compared to standard of care (SOC) in second-line relapsed or refractory large B-cell lymphoma (LBCL). With a median follow-up of two years, the study met the primary endpoint of event-free survival (EFS; hazard ratio 0.398, p <0.0001). The study also met the key secondary endpoint of objective response rate (ORR). The interim analysis of overall survival (OS) showed a trend favoring Yescarta; however, the data are immature at this time, and further analyses are planned for the future.

Kite Pharma ZUMA-7 Global Clinical Trial Sites Map - Centers

Overall survival measures deaths over time from any cause. Event-free survival is defined as time from randomization to disease progression, commencement of new lymphoma therapy, or death from any cause. ZUMA-7 was conducted under a Special Protocol Agreement (SPA) with the U.S. Food and Drug Administration (FDA) whereby the trial design, clinical endpoints and statistical analysis were agreed in advance with the Agency.

Safety results from the study were consistent with or lower than the known safety profile of Yescarta for the treatment of LBCL in the third-line setting. Six percent of patients experienced cytokine release syndrome (CRS) Grade 3 or higher, with a median onset of three days, and 21% experienced neurological events Grade 3 or higher. No new safety concerns were identified in this second-line setting.

“The top-line results of the randomized ZUMA-7 trial paint the picture of a potential paradigm shift in the treatment of large B-cell lymphoma,” said Frederick L. Locke, MD, ZUMA-7 Lead Principal Investigator and Co-Leader of the Immuno-Oncology Program at Moffitt Cancer Center, Tampa, Florida. “The outcomes for patients relapsing after frontline chemotherapy in this study are dramatically improved with rapid referral (to a CAR T center) and a single infusion of axicabtagene ciloleucel as compared to chemotherapy and consolidative autologous transplant, the longstanding second-line standard of care.”

ZUMA-7 evaluated an one-time infusion of the CAR T-cell therapy Yescarta compared to SOC in adult patients with relapsed or refractory LBCL. Standard of care for relapsed or refractory LBCL is a two-step process: immunochemotherapy is reintroduced, and if the patient responds and can tolerate further treatment, they move on to high-dose chemotherapy plus stem cell transplant.

“Yescarta has been instrumental in transforming outcomes for patients with third-line LBCL. Our goal has always been to bring the benefit of CAR T-cell therapy to more patients, earlier in their treatment, where the potential for benefit may be even greater,” said Christi Shaw, Chief Executive Officer of Kite. “As the leader in cell therapy, Kite is honored to deliver this landmark study and would like to thank the patients, families, physicians and care teams around the world that made this possible.”

ZUMA-7 was initiated in 2017 and enrolled 359 patients in 77 centers around the world. Results released today represent the longest follow-up time of any study in this setting with two years median follow-up. Patients enrolled in the study ranged in age from 22 to 81, with 30% of the patients 65 or older.

“Over 40 years ago, we learned the important role T-cells play in fighting cancer, and 20 years ago autologous stem cell transplant became an option to treat lymphoma. Today's results show us the potential power of cell therapy for patients with lymphoma when used earlier, and instead of standard treatment options,” said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development.

Detailed results from ZUMA-7 will be submitted for presentation at a future medical congress, and Kite plans to initiate discussions with the U.S. Food and Drug Administration, European Medicines Agency and other global health authorities regarding submission of a supplemental Biologics License Application later this year to expand the currently approved indications for Yescarta. See About Yescarta section for current Yescarta approved indications. Yescarta has not been approved by any regulatory agency for the treatment of patients in the second-line setting similar to those in ZUMA-7.

About 40% of patients with LBCL will need second-line treatment, as their cancer will either relapse (return) or become refractory (not respond) to treatment.

About ZUMA-7 Study Design

ZUMA-7 is a randomized, open-label, global, multicenter, Phase 3 study evaluating the safety and efficacy of Yescarta versus current standard of care (SOC) for second-line therapy (platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy) in adult patients with relapsed or refractory (within or equal to 12 months of first-line therapy), large B-cell lymphoma (LBCL). In the study, 359 patients were randomized (1:1) to receive a single infusion of Yescarta or current SOC second-line therapy. The primary endpoint is event-free survival (EFS), defined as the time from randomization to the earliest date of disease progression per Lugano Classification (Cheson et al, 2014), commencement of new lymphoma therapy, or death from any cause as determined by blinded central review. Key secondary endpoints include objective response rate (ORR) and overall survival (OS). Other secondary endpoints include modified EFS, progression-free survival (PFS) and duration of response (DOR).

About Yescarta

Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated 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, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.
  • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with commercial manufacturing operations in North America and Europe. Kite’s singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

SOURCE: Gilead Sciences

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