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11-Mar-2021

Kite, a Gilead Company, to share latest scientific advances in cell therapy research at the 47th Virtual Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT)

  • Eleven abstracts will be presented demonstrating Kite’s continued commitment to innovation in cell therapy for patients with blood cancers.
  • Updated survival analysis for axicabtagene ciloleucel (Yescarta®) in relapsed/refractory diffuse large B cell lymphoma.
  • Pivotal data presentation for first licensed CAR T therapy in relapsed/refractory mantle cell lymphoma, autologous anti-CD19-transduced CD3+ cells (Tecartus®).
  • Two-year retrospective data on manufacturing commercial axicabtagene ciloleucel for European patients.

“We are pleased to share our advancing research and key data being presented at the virtual EBMT 2021,” said Dick Sundh, Vice President, Head of Australia, Canada and Europe (ACE), Kite. “Presentations include our pivotal ZUMA-1 survival analysis in large B cell lymphoma and a retrospective analysis of our manufacture and delivery of axicabtagene ciloleucel for European and Israeli adult patients. These data highlight the potential benefits of CAR T cell therapies, and our continued commitment to reach those patients who have limited treatment options.”

 

Data highlights:

 

ZUMA-1: Axicabtagene Ciloleucel

Updated overall survival results at four years of axicabtagene ciloleucel (Yescarta®) in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL) will be presented.

 

ZUMA-1 investigational safety management cohort (Cohort 6) data will be presented on prophylactic corticosteroid use in patients with relapsed/refractory DLBCL receiving axicabtagene ciloleucel. This use remains investigational, with its efficacy and safety not established in this setting.

 

ZUMA-2: Autologous Anti-CD19-transduced CD3+ Cells

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

 

ZUMA-5: Axicabtagene Ciloleucel

Primary analysis of axicabtagene ciloleucel in adult patients with relapsed/refractory indolent non-Hodgkin lymphoma (iNHL) after at least two prior lines of therapy. This use remains investigational, with its efficacy and safety not established in this setting.

 

Manufacturing: Axicabtagene Ciloleucel European Patients

Two-year retrospective analysis for the commercial manufacturing and supply of axicabtagene ciloleucel in 1074 European and Israeli adult patients with relapsed/refractory DLBCL and primary mediastinal LBCL after two prior lines of systemic therapy.

 

 

Study Name, Area of Focus and Presentation Number

Abstract Title and Primary Author

            Oral Abstract Presentations

ZUMA-1: Diffuse Large B Cell Lymphoma

Abstract #OS19-2

Long-Term Survival and Gradual Recovery of B Cells in Patients with Refractory Large B Cell Lymphoma (LBCL) Treated with Axicabtagene Ciloleucel (Axi-Cel). Caron Jacobson, MD et al. 

ZUMA-1: Diffuse Large B Cell Lymphoma

Abstract #OS2-2

Prophylactic Corticosteroid use with Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory Large B Cell Lymphoma (R/R LBCL). Olalekan O. Oluwole, MD et al. 

ZUMA-2: Mantle Cell Lymphoma 

Abstract #OS3-3

Pharmacology and Efficacy of KTE-X19 by Prior Bruton Tyrosine Kinase Inhibitor Exposure or Mantle Cell Lymphoma (MCL) Morphology in Patients with Relapsed/Refractory MCL in ZUMA-2. Michael Wang, MD et al. 

ZUMA-2: Mantle Cell Lymphoma 

Abstract #OS19-4

One-Year Follow-Up of ZUMA-2, The Multicenter, Registrational Study of KTE-X19 in Patients with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL). Michael Wang, MD et al. 

ZUMA-5: Non-Hodgkin Lymphoma

Abstract #OS19-3

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). Caron Jacobson, MD et al. 

ZUMA-12: Large B-cell Lymphoma 

Abstract #OS19-1

 

Interim Analysis (IA) 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). Sattva S. Neelapu, MD et al.

ePoster Presentations

European Manufacturing

Abstract #P017

 

Manufacturing Commercial Axicabtagene Ciloleucel (Axi-Cel) for European Patients: A 2-Year Retrospective Analysis. Louis van der Wiel, Dominique Tonelli et al.

Health Economics and Outcomes Research: CE of KTE-X19 Mantle Cell Lymphoma

Abstract #P019

Cost-Effectiveness (CE) of KTE-X19 CAR T Therapy Following Bruton Tyrosine Kinase Inhibitor Treatment for Relapsed/Refractory Mantle Cell Lymphoma in England. C.L. Simons, et al. 

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

Abstract #P009

ZUMA-4: A Phase 1/2 Multicenter Study Of KTE-X19 in Pediatric and Adolescent Patients with Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia (ALL) or Non-Hodgkin Lymphoma (NHL). Alan S. Wayne, MD et al.

ZUMA-5: Non-Hodgkin Lymphoma

Abstract #P015

Retreatment with Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory (R/R) Indolent Non-Hodgkin Lymphoma (iNHL) in ZUMA-5. Julio C. Chavez, MD et al. 

ZUMA-19: Large B Cell Lymphoma

Abstract #P025

 

ZUMA-19: A Phase 1/2 Multicenter Study of Lenzilumab with Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed or Refractory Large B Cell Lymphoma (R/R LBCL). Saad J. Kenderian, MB, ChB et al.

Conference registration is required to access oral presentations and ePosters.

 

For more information please visit: https://www.ebmt.org/annual-meeting. Please note, this is an external site belonging to the European Society for Blood and Marrow Transplantation.

 

The following Kite spokespeople will be available:

  • Dick Sundh, Vice President, Head of ACE, Kite
  • Anne Kerber, Vice President, Head Clinical Development EU, Kite
  • Dominique Tonelli, Head of Medical Affairs, ACE, Kite
  • Louis van de Wiel, Vice President, Site Head Kite Europe

For more information or to arrange an interview, contact Cressida Robson, Media, ACE, 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.[i]

 

About Kite’s Autologous Anti-CD19-transduced CD3+ Cells

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

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.[iii]

 

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 ZUMA-5

ZUMA-5 is a single-arm, multi-centre, Phase 2 open-label study that aims to enrol adult patients with relapsed/refractory indolent Non-Hodgkin lymphomas (iNHL) of either follicular lymphoma (FL) or marginal zone lymphoma (MZL) subtypes, who received at least two prior lines of systemic therapy, including an anti-CD20 monoclonal antibody combined with an alkylating agent. The objectives of the study are to evaluate the efficacy and safety of a single infusion of axicabtagene ciloleucel in this patient population. The primary endpoint of the trial is objective response rate (ORR) as assessed by an independent review committee Lugano Classification (2014). The study is ongoing. Axicabtagene ciloleucel is not approved for use in relapsed/refractory indolent non-Hodgkin lymphoma in Europe.

 

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 Tecartus® 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 31 December 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, Axi-Cel, Tecartus and GILEAD are trademarks of Gilead Sciences, Inc., or its related companies. 

 

[i] European Medicines Agency. Yescarta® (axicabtagene ciloleucel) SPC. Available at: https://www.ema.europa.eu/documents/product-information/yescarta-epar-product-information_en.pdf. Accessed March 2021.

[ii] 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.

[iii] 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 March 2021.

 

Editor Details

Last Updated: 11-Mar-2021