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04-Feb-2021

Kite, a Gilead Company, to share latest scientific advances in haematologic malignancies at the 3rd European CAR T-cell Meeting •

Kite, a Gilead Company, to share latest scientific advances in haematologic malignancies at the 3rd European CAR T-cell Meeting

 

  • Nine abstracts, highlighting the company’s continued commitment to innovation in immuno-oncology for patients with blood cancers, at the 3rd European CAR T-cell Meeting.
  • Pivotal data presentation for first licensed CAR T therapy in relapsed/refractory mantle cell lymphoma, autologous anti-CD19-transduced CD3+ Cells (Tecartus®).
  • Updated survival analysis for axicabtagene ciloleucel (Yescarta®) in relapsed/refractory diffuse large B cell lymphoma.
  • New safety management data in relapsed/refractory diffuse large B cell lymphoma and data in other blood cancer types.

 

“We are proud to support the 3rd European CAR T-cell Meeting, with presentations including the first ever four-year data from our pivotal ZUMA-1 trial that shows the potential long-term survival in relapsed/refractory diffuse large B cell lymphoma, as well as data from our ZUMA-2 pivotal clinical trial in relapsed/refractory mantle cell lymphoma.” said Dick Sundh, Vice President, Head of Australia, Canada and Europe (ACE), Kite. “With these data, we continue to strive to address the unmet need of patients with difficult-to-treat haematologic malignancies.”

 

ZUMA-1: Axicabtagene Ciloleucel

Updated overall survival results at four 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-2: Autologous Anti-CD19-transduced CD3+ Cells

Updated analysis of efficacy, safety, and pharmacology for the one-year follow-up results from the ZUMA-2 study evaluating autologous anti-CD19-transduced CD3+ cells (Tecartus®) in relapsed/refractory mantle cell lymphoma will be presented.

 

Abstracts published at the meeting* will include:

Study Name: Area of Focus and Primary Author

Abstract Title

Poster Presentations

ZUMA-1: Diffuse Large B Cell Lymphoma

Caron Jacobson, MD et al.

P012 - ID054

Long-Term Survival and Gradual Recovery of B Cells in Patients With Refractory Large B Cell Lymphoma Treated With Axicabtagene Ciloleucel (Axi-Cel)

ZUMA-1: Diffuse Large B Cell Lymphoma

Olalekan O. Oluwole, MD et al.

P011 - ID046

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

ZUMA-2: Mantle Cell Lymphoma 

Michael Wang, MD et al.

P006 - ID058

 

 

Pharmacological Profile and Clinical Outcomes of KTE-X19 by Prior Bruton Tyrosine Kinase Inhibitors (BTKi) Exposure or Mantle Cell Lymphoma (MCL) Morphology in Patients With Relapsed/Refractory (R/R) MCL in the ZUMA-2 Trial

ZUMA-2: Mantle Cell Lymphoma 

Michael Wang, MD et al. 

P013 - ID060

One-Year Follow-Up of ZUMA-2, the Multicenter, Registrational Study of KTE-X19 in Patients With Relapsed/Refractory Mantle Cell Lymphoma

ZUMA-4: Acute Lymphoblastic Leukaemia & Non-Hodgkin Lymphoma

Alan S. Wayne, MD et al.

P068 - ID063

ZUMA-4 TiP (Trial in Progress): A Phase 1/2 Multicenter Study of KTE-X19 in Pediatric and Adolescent Patients With Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma

ZUMA-5: Non-Hodgkin Lymphoma

Caron Jacobson, MD et al.

P004 - ID061 

Primary 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)

ZUMA-5: Non-Hodgkin Lymphoma

Julio C. Chavez, MD et al. 

P009 - ID059

Retreatment With Axicabtagene Ciloleucel (Axi-Cel) in Patients With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma in ZUMA-5

ZUMA-12: Large B-cell Lymphoma 

Sattva S. Neelapu, MD et al. 

P002 - ID048

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

ZUMA-19: Large B Cell Lymphoma

Saad J. Kenderian, MB, ChB et al

P059 - ID056

ZUMA-19 TiP (Trial in Progress): A Phase 1/2 Multicenter Study of Lenzilumab Use with Axicabtagene Ciloleucel (Axi-Cel) in Patients (Pts) With Relapsed or Refractory Large B Cell Lymphoma (R/R LBCL)

For more information please visit: https://www.ebmt.org/events/3rd-european-car-t-cell-meeting-virtual.

 

*The embargo for each full abstract will be lifted on the morning of the date of presentation.

 

For more information or to arrange a reactive interview please contact Cressida Robson, Media (Australia, Canada and Europe), Kite (+44 7341 789 204 or cressida.robson@kitepharma.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 Kite’s Autologous Anti-CD19-transduced CD3+ Cells

Autologous anti-CD19-transduced CD3+ cells (formally known as KTE-X19) is a chimeric antigen receptor (CAR) T cell therapy.[2]

In December 2020, the European Commission granted conditional Marketing Authorisation for autologous anti-CD19-transduced CD3+ cells, the first CAR T approved in Europe for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.[3]

 

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-2 

ZUMA-2 is a multinational, single-arm, Phase 2 open-label pivotal trial. The study enrolled 74 adult patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a BTK inhibitor (ibrutinib or acalabrutinib). Autologous anti-CD19-transduced CD3+ cells were manufactured for 71 patients and administered to 68 patients. The primary endpoint was objective response rate per the Lugano Classification (2014), defined as the combined rate of complete response and partial responses as assessed by an Independent Radiologic Review Committee.2

 

About Kite 

Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California, with commercial manufacturing operations in North America and Europe. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies. 

 

About Gilead Sciences 

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.  

 

Forward-Looking Statement 

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 the possibility of unfavorable results from ongoing and additional clinical studies involving Yescarta and KTE-X19 and the possibility that Kite may be unable to initiate or complete one or more of such studies in the currently anticipated timelines or at all. There is also the risk that the FDA may not approve Yescarta for the treatment of any other lymphomas in the anticipated timelines or at all, and any marketing approvals if granted, may have significant limitations on its use. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended 30 September 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation to update any such forward-looking statements. 

 

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Kite, the Kite logo, Yescarta, axicabtagene ciloleucel, Tecartus 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 2021.

[2] Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma. N Engl J Med. 2020;382:1331-1342.

[3] European Medicines Agency. Tecartus® (autologous anti-CD19-transduced CD3+ cells) SPC. Available at: https://www.ema.europa.eu/en/documents/product-information/tecartus-epar-product-information_en.pdf. Accessed February 2021.

 

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Last Updated: 05-Feb-2021