U.S. FDA Approves Label Update For Kite’s Yescarta® CAR T-Cell Therapy To Include Overall Survival Data
January 2 , 2024
By Gilead, December 21, 2023
-- Yescarta is the First and Only Treatment in Nearly 30 Years to Demonstrate Superior Overall Survival for Patients with Relapsed/Refractory Large B-cell Lymphoma Versus Standard of Care as Second-Line Treatment With Curative Intent* --
SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Yescarta® (axicabtagene ciloleucel) to include the overall survival (OS) primary analysis from the landmark Phase 3 ZUMA-7 study showing a statistically significant improvement for Yescarta in OS versus standard of care (SOC) as second-line treatment with curative intent for patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) within 12 months of completion of first-line therapy.
The label update is based on results from the ZUMA-7 study which demonstrated a 27.4% reduction in the risk of death with Yescarta versus SOC, a relative 38% improvement in OS. With an estimated median follow up of 46.7 months overall, the primary analysis of OS showed a statistically significant improvement in the Yescarta arm compared to the standard therapy arm, despite more than half of patients (57%) in the SOC arm subsequently receiving cell therapy off protocol. The estimated 39-month OS rates were 55.9% in the Yescarta arm and 46% in the SOC arm.
“This U.S. label update for Yescarta is an important step to reinforce healthcare provider confidence to treat eligible patients with Yescarta, immediately following progression or relapse in large B-cell lymphoma,” said Frank Neumann, MD, PhD, Senior Vice President and Global Head of Clinical Development, Kite. “Our ZUMA-7 overall survival analysis proves that when given as second-line therapy, Yescarta is even more effective in improving patient survival than standard of care treatment. Coupled with our rapid and reliable manufacturing, it is our hope to provide patients a chance to live longer lives.”
SOC therapy for this patient population has historically been a multi-step process expected to end with stem-cell transplant. The process starts with chemoimmunotherapy, and if a patient responds and can tolerate further treatment, they move on to high-dose chemotherapy (HDT), followed by autologous stem cell transplant (ASCT). Despite this being the prior SOC, less than 40% of patients who started this multi-step process made it through to complete stem cell transplant, compared with 94% of patients randomized to Yescarta in the ZUMA-7 study who received a one-time Yescarta infusion.
Underscoring the Significance for Patients
As the first and only treatment in nearly 30 years to improve survival for patients with R/R LBCL in this setting, Yescarta can potentially change the standard of care for these patients who previously had limited options for long-term remission.
“Lymphoma Research Foundation has continuously supported efforts for the development of new treatments in large B-cell lymphoma with the shared goal of finding a cure,” said Meghan Gutierrez, Chief Executive Officer, Lymphoma Research Foundation. “We applaud Kite for bringing the oncology community one step closer to eradicating large B-cell lymphoma and offering new hope to patients.”
In November 2023, the European Medicines Agency approved an update to the Summary of Product Characteristics (SmPC) to include the ZUMA-7 overall survival analysis.
*Treatment of curative intent is a line of treatment administered with the goal of achieving a durable complete response/ remission. 2017. NIH National Library of Medicine “Curative, Life-Extending and Palliative Chemotherapy: New Outcomes Need New Names”
-- Yescarta is the First and Only Treatment in Nearly 30 Years to Demonstrate Superior Overall Survival for Patients with Relapsed/Refractory Large B-cell Lymphoma Versus Standard of Care as Second-Line Treatment With Curative Intent* --
SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Yescarta® (axicabtagene ciloleucel) to include the overall survival (OS) primary analysis from the landmark Phase 3 ZUMA-7 study showing a statistically significant improvement for Yescarta in OS versus standard of care (SOC) as second-line treatment with curative intent for patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) within 12 months of completion of first-line therapy.
The label update is based on results from the ZUMA-7 study which demonstrated a 27.4% reduction in the risk of death with Yescarta versus SOC, a relative 38% improvement in OS. With an estimated median follow up of 46.7 months overall, the primary analysis of OS showed a statistically significant improvement in the Yescarta arm compared to the standard therapy arm, despite more than half of patients (57%) in the SOC arm subsequently receiving cell therapy off protocol. The estimated 39-month OS rates were 55.9% in the Yescarta arm and 46% in the SOC arm.
“This U.S. label update for Yescarta is an important step to reinforce healthcare provider confidence to treat eligible patients with Yescarta, immediately following progression or relapse in large B-cell lymphoma,” said Frank Neumann, MD, PhD, Senior Vice President and Global Head of Clinical Development, Kite. “Our ZUMA-7 overall survival analysis proves that when given as second-line therapy, Yescarta is even more effective in improving patient survival than standard of care treatment. Coupled with our rapid and reliable manufacturing, it is our hope to provide patients a chance to live longer lives.”
SOC therapy for this patient population has historically been a multi-step process expected to end with stem-cell transplant. The process starts with chemoimmunotherapy, and if a patient responds and can tolerate further treatment, they move on to high-dose chemotherapy (HDT), followed by autologous stem cell transplant (ASCT). Despite this being the prior SOC, less than 40% of patients who started this multi-step process made it through to complete stem cell transplant, compared with 94% of patients randomized to Yescarta in the ZUMA-7 study who received a one-time Yescarta infusion.
Underscoring the Significance for Patients
As the first and only treatment in nearly 30 years to improve survival for patients with R/R LBCL in this setting, Yescarta can potentially change the standard of care for these patients who previously had limited options for long-term remission.
“Lymphoma Research Foundation has continuously supported efforts for the development of new treatments in large B-cell lymphoma with the shared goal of finding a cure,” said Meghan Gutierrez, Chief Executive Officer, Lymphoma Research Foundation. “We applaud Kite for bringing the oncology community one step closer to eradicating large B-cell lymphoma and offering new hope to patients.”
In November 2023, the European Medicines Agency approved an update to the Summary of Product Characteristics (SmPC) to include the ZUMA-7 overall survival analysis.
*Treatment of curative intent is a line of treatment administered with the goal of achieving a durable complete response/ remission. 2017. NIH National Library of Medicine “Curative, Life-Extending and Palliative Chemotherapy: New Outcomes Need New Names”