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10-Feb-2022

Kite, a Gilead Company, continues to advance research with longest CAR T cell therapy follow-up data at the 4th European CAR T-cell Meeting

FOR EUROPEAN MEDICAL AND HEALTHCARE MEDIA ONLY

 

MEDIA ADVISORY

Kite, a Gilead Company, continues to advance research with longest CAR T cell therapy follow-up data at the 4th European CAR T-cell Meeting

 

  • Pivotal data on earlier use of CAR T cell therapy as second-line treatment in relapsed/refractory diffuse large B cell lymphoma
  • Safety management data in relapsed/refractory diffuse large B cell lymphoma

 

“We are pleased to support the 4th European CAR T-cell Meeting with presentations demonstrating potential long-term survival with CAR T cell therapy in relapsed/refractory diffuse large B cell lymphoma,” said Dick Sundh, Vice President, Head of Australia, Canada and Europe (ACE), Kite.
“First European presentations of our pivotal head-to-head ZUMA-7 trial and patient-reported outcomes in second-line relapsed/refractory diffuse large B cell lymphoma also support our ongoing commitment to patients with hard-to-treat blood cancers.”

 

ZUMA-1: Axicabtagene Ciloleucel

Updated overall survival results at five years from the pivotal ZUMA-1 trial of axicabtagene ciloleucel (Yescarta®) in patients with relapsed/refractory diffuse large B cell lymphoma will be presented.

 

ZUMA-7: Axicabtagene Ciloleucel

The first European presentation of the pivotal Phase 3 ZUMA-7 study primary analysis and patient-reported outcomes, evaluating the safety and efficacy of axicabtagene ciloleucel versus current standard of care for second-line therapy in relapsed/refractory diffuse large B cell lymphoma.

 

Abstracts published at the meeting will include:

 

Study Name and Abstract Number

Abstract Title

Primary Author

 

E-Poster and Flash Talk

ZUMA-1 Cohort 6 One-Year

 

Poster Number:

AS-CART-2022-00058

PT02-4 Thurs 10 Feb, 19:29 CET

Prophylactic Corticosteroids with Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory Large B-Cell Lymphoma (R/R LBCL)

 

Olalekan O. Oluwole

ZUMA-7 Elderly

 

Poster Number:

AS-CART-2022-00054

PT02-1 Thurs 10 Feb, 19:20 CET

Superiority of Axicabtagene Ciloleucel (Axi-Cel) in Second-Line (2L) Large B-Cell Lymphoma (LBCL) in the Elderly 

 

 

Tom van Meerten

E-Poster Presentation

ZUMA-1 Five-Year Overall Survival

 

Poster Number:

AS-CART-2022-00058

Long-Term (5 Year) Overall Survival in ZUMA-1,
the Pivotal Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Refractory Large B-Cell Lymphoma (LBCL) 

 

Caron A. Jacobson

Real World Evidence: CIBMTR Registry Asian Descent Subset Analysis

 

Poster Number:

AS-CART-2022-00138

Real-world Outcomes of Axicabtagene Ciloleucel (Axi-cel) for the Treatment of Large B-cell Lymphoma (LBCL): Subset Analysis of Patients with Asian Descent

 

 

Tanya Siddiqi

ZUMA-7 Primary Analysis

 

Poster Number:

AS-CART-2022-00055

Primary Analysis of ZUMA-7: A Phase 3 Randomized Trial of Axicabtagene Ciloleucel (Axi-Cel) Versus Standard of Care (SOC) Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma

 

Frederick L. Locke

Health Economics and Outcomes Research: ZUMA-7 Patient Reported Outcomes

 

Poster Number:

AS-CART-2022-00057

Patient-Reported Outcomes in ZUMA-7, a Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel (Axi-Cel) Versus Standard-of-Care Therapy in Relapsed/Refractory Large B-Cell Lymphoma

 

Mahmoud Elsawy

ZUMA-5 Two-Year Follow-Up

 

Poster Number:

AS-CART-2022-00053

Long-Term Follow-Up Analysis of ZUMA-5: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory (R/R) Indolent Non-Hodgkin Lymphoma (iNHL)

 

Julio Chavez

ZUMA-12 Primary Analysis

 

Poster Number:

AS-CART-2022-00049

Primary Analysis of ZUMA-12: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-Cel) as First-Line Therapy in Patients with High-Risk Large B-Cell Lymphoma (LBCL)

 

Julio Chavez/Sattva S. Neelapu

 

For more information visit: https://www.ebmt.org/events/ebmt-eha-4th-european-car-t-cell-meeting. This site does not belong to Kite.

 

Available spokespeople:

  • Dick Sundh, Vice President, Head of ACE, Kite 
  • Dominique Tonelli, Head of Medical Affairs, ACE, Kite

 

For more information or to arrange an interview contact Cressida Robson on +44 7341 789 204 or cressida.robson@gilead.com.

 

# # #

 

 

About Axicabtagene Ciloleucel

In August 2018, axicabtagene ciloleucel, a chimeric antigen receptor (CAR) T cell therapy, received European Marketing Authorisation for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy.[1]

 

About ZUMA-1

ZUMA-1 is an ongoing single-arm, open-label pivotal Phase 1/2 trial evaluating the safety and efficacy of Chimeric Antigen Receptor (CAR) T cell therapy, axicabtagene ciloleucel, in adult patients with refractory aggressive non-Hodgkin lymphomas (NHL).

 

About ZUMA-7

ZUMA-7 is a randomised, open-label, global, multicentre, Phase 3 study of 359 patients at 77 centres, evaluating the safety and efficacy of axicabtagene ciloleucel versus current standard of care for second-line therapy in adult patients with relapsed or refractory LBCL. The primary endpoint is event free survival (EFS). Key secondary endpoints include objective response rate (ORR) and overall survival (OS). Additional secondary endpoints include patient reported outcomes (PROs) and safety. 

 

About Kite 

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with 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. 

 

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. 

 

Gilead and Kite Forward-Looking Statements 

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead and Kite’s ability to initiate, progress or clinical studies within currently anticipated timelines or at all, including those involving axicabtagene ciloleucel; the possibility of unfavorable results from ongoing and additional clinical studies, including those involving axicabtagene ciloleucel and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the year ended December 31, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements. 

 

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Kite, the Kite logo, Yescarta, axicabtagene ciloleucel and GILEAD are trademarks of Gilead Sciences, Inc., or its related companies. 

 

[1] European Medicines Agency. Yescarta® (axicabtagene ciloleucel) SPC. Available at: https://www.ema.europa.eu/documents/product-information/yescarta-epar-product-information_en.pdf. Accessed February 2022.

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Last Updated: 10-Feb-2022