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Gilead and Kite Oncology Demonstrate Transformative Impact of Cell Therapy and Promise of Blood Cancer Portfolio at ASH 2022

November 3, 2022 – BioManufacturing –

Stockley Park, UK – 3 November 2022 – Gilead Sciences, Inc. and Kite, a Gilead Company, will support 30 data presentations, including seven oral presentations in large B-cell lymphoma (LBCL) and two oral presentations on investigator-sponsored studies in acute myeloid leukaemia (AML), during the 64th Annual American Society of Hematology (ASH) Annual Meeting (10-13 December).

‘Every year we see more patients benefitting in profound ways from CAR T-cell therapy,’ said Frank Neumann, MD, PhD, Senior Vice President, Global Head of Clinical Development, Kite. ‘The breadth of real-world evidence and multi-year follow-up in pivotal studies we present this year can reinforce physiciansí confidence in the durability and reliability of Kiteís CAR T-cell therapies.’

Key presentations for Kiteís CAR T-cell therapies include three-year results from ZUMA-5 in indolent non-Hodgkin lymphoma (iNHL) and exploratory data from the three-year results from ZUMA-2 in mantle cell lymphoma (MCL) and two-year results from ZUMA-3 in B-cell acute lymphoblastic leukaemia (ALL). Additional Kite research will focus on new sub-analyses of ZUMA-7 in LBCL, and real-world experience studying the impact of time from leukapheresis to infusion on patient outcomes.  

‘We continue to grow the body of evidence for new therapeutic options that improve how we treat blood cancers, which include some of the most challenging tumours,’ said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. ‘With our recently announced collaboration with MacroGenics to develop their second-generation CD123 bispecific antibody, we are excited about our presence at ASH and the potential of our pipeline to improve patient outcomes across a variety of haematological cancers.’

An oral presentation showcasing results from a Phase 1/2 study of our investigational, anti-CD47 immunotherapy, in combination with azacitidine and venetoclax in patients with newly diagnosed older/unfit AML and relapsed/refractory AML, also will be presented. Dates and times for accepted abstracts and presentations of note are as follows:

 Abstract Details  

Titles  

Oral
Presentations  

Large B-Cell Lymphoma  

 

Abstract #259  

Saturday, 10 December  

(19:00 GMT / 20:00 CET / 14:00 EST)  

 

Association of Metabolic Tumor Volume (MTV) and
Clinical Outcomes in Second-Line (2L) Relapsed/Refractory (R/R) Large B-Cell Lymphoma
(LBCL) Following Axicabtagene Ciloleucel (axi-cel) Versus Standard-of-Care
(SOC) Therapy in ZUMA-7  

Frederick
Locke 

Abstract #261  

Saturday, 10 December  

(19:30 GMT / 20:30 CET / 14:30 EST) 

  

Durable Response to Axi-Cel CD19 Therapy is
Associated with Activation and Clonotypic Expansion of the Native T Cell
Repertoire 

Giulia
Cheloni  

Abstract #262  

Saturday, 10 December  

(19:45 GMT / 20:45 CET / 14:45 EST) 

  

Patients with Deleterious Germline Variants in
STXBP2 Develop Toxicity After CAR-T Cell Therapy With Axicabtagene
Ciloleucel  

Mark
Leick  

Abstract #440  

Sunday, 11 December  

(14:45 GMT / 15:45 CET / 09:45 EST) 

 

A Pilot Study of Axicabtagene Ciloleucel (axi-cel)
for the Treatment of Relapsed/Refractory Primary and Secondary Central
Nervous System Lymphoma (CNSL)  

Caron
Jacobson 

Abstract #659  

Sunday, 11 December  

(22:30 GMT / 23:30 CET / 17:30 EST)  

  

Outcomes of Subsequent Anti-Lymphoma Therapies in
Patients (Pts) with Large B-Cell Lymphoma (LBCL) Treated with Axicabtagene
Ciloleucel (axi-cel) or Standard of Care (SOC) in the Second-Line (2L) ZUMA-7
Study 

Armin
Ghobadi 

 

Abstract #765  

Monday, 12 December  

(16:00 GMT / 17:00 CET / 11:00 EST)  

 

Outcomes of Axicabtagene Ciloleucel in Comparison
with Chemoimmunotherapy (CIT) in an Elderly Population for Treatment of
Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) After Two or More
Lines of Prior Therapy 

Matthew
Lunning 

Abstract #892  

Monday, 12 December  

(17:30 GMT / 18:30 CET / 12:30 EST) 

  

Hospital Costs and HCRU CAR T-Cell Therapy and
Hematopoietic Cell Transplant (HCT) in Patients with LBCL in the US   

Chendi
Cui  

Acute Myeloid Leukaemia

 

Abstract #61

Saturday, 10 December

(15:30 GMT / 16:30 CET / 10:30 EST)

**Investigator Sponsored Research **

Phase I/II Study of Azacitidine (AZA) with
Venetoclax (VEN) and Magrolimab (Magro) in Patients (pts) with Newly Diagnosed
(ND) Older/Unfit or High-risk Acute Myeloid Leukemia (AML) and
Relapsed/Refractory (R/R) AML 

Naval Davar

 

Abstract #603

Sunday, 11 December

(22:30 GMT / 23:30 CET / 17:30 EST) 

**Investigator Sponsored Research ** 

Clinical Characteristics and Overall Survival Among
Acute Myeloid Leukemia (AML) Patients With TP53 Gene Mutation (TP53m) or
Chromosome 17p Deletion (17p del) 

Naval Davar

 

Poster
Presentations  

Large B-Cell Lymphoma 

 

Abstract #2274  

Saturday, 10 December  

(22:30 GMT / 23:30 CET / 17:30 EST) 

  

Real-World Patient-Reported Outcomes among
Recipients of Axicabtagene Ciloleucel for R/R LBCL 

Heather
S.L. Jim  

Abstract #2022  

Saturday, 10 December  

(22:30 GMT / 23:30 CET / 17:30 EST) 

  

The Real-World Use of Bridging Therapy (BT) in
Relapsed or Refractory LBCL Patients Treated with CAR T-cell Therapy: A
Systematic Literature Review 

Javier
Munoz  

Abstract #1618

Saturday, 10 December

(23:30 GMT / 18:30 EST/ Sunday, 11 December 00:30 CET)

 

Magrolimab in Combination With Rituximab +
Chemotherapy in Patients With Relapsed or Refractory (R/R) Diffuse Large
B-Cell Lymphoma (DLBCL) 

Joseph Maakaron 

Abstract #3345  

Sunday,11 December  

(23:00 GMT / 18:00 EST/ Monday, 12
December 00:00 CET) 

 

Real-world Impact of Time from Leukapheresis to
Infusion (Vein-to-Vein Time) in Patients with r/r LBCL Treated with Axi-cel 

Frederick
Locke  

Abstract #3346  

Sunday, 11 December  

(23:00 GMT / 18:00 EST/ Monday, 12
December 00:00 CET /)   

Network Meta-Analysis (NMA) of CART-Cell Therapy for
the Treatment of R/R DLBCL After 2 Prior Treatments Using Published
Comparative Studies 

Frederick
Locke  

Abstract #4667  

Monday, 12 December  

(23:00 GMT /18:00 EST/ Tuesday 13 00:00 CET)

 

Prophylactic Corticosteroid Use with Axicabtagene
Ciloleucel (axi-cel) in Patients (Pts) with Relapsed/Refractory Large B-Cell
Lymphoma (R/R LBCL): 2-Year Follow-Up of ZUMA-1 Cohort 6 

Olalekan
Oluwole  

Abstract #4635  

Monday, 12 December  

(23:00 GMT /18:00 EST/ Tuesday 13 00:00 CET)

 

ZUMA-19: A Phase 1/2 Study of Axicabtagene
Ciloleucel Plus Lenzilumab in Patients With Relapsed or Refractory Large
B-cell Lymphoma 

Olalekan
Oluwole  

Relapsed/Refractory Mantle Cell Lymphoma  

 

Abstract
#4199  

Monday, 12 December  

(23:00 GMT /18:00 EST/ Tuesday 13 00:00 CET)

Assessment of Durable Responses After Brexucabtagene
Autoleucel (KTE-X19) in the ZUMA-2 Study in Relapsed/Refractory Mantle Cell
Lymphoma (R/R MCL) 

Javier
Munoz 

 

Abstract
#4627  

Monday, 12 December  

(23:00 GMT /18:00 EST/ Tuesday 13 00:00 CET)

 

A Comparison of Overall Survival with Brexucabtagene
Autoleucel (Brexu-cel) CAR T-Cell Therapy (ZUMA-2) and Standard of Care (SCHOLAR-2)
in Patients with Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL)
Previously Treated with a Covalent Bruton Tyrosine Kinase Inhibitor (BTKi) 

Georg
Hess 

 

Leukaemia

 

Abstract #1368  

Saturday, 10 December  

(22:30 GMT / 23:30 CET / 17:30 EST) 

 

Updated Outcomes From the Historical Control Study
SCHOLAR-3 Contextualizing ZUMA-3 Results of Brexucabtagene Autoleucel
(KTE-X19) in Adult Patients With Relapsed or Refractory B-Cell Acute
Lymphoblastic Leukemia (R/R B-ALL)  

Bijal
D. Shah 

 

Abstract #3319  

Sunday, 11 December  

(23:00 GMT / 18:00 EST/ Mon 12 Dec 00:00 CET) 

  

A Phase 1 Study of KTE-X19, an Anti-CD19 Chimeric
Antigen Receptor (CAR) T-cell Therapy, in Patients With Relapsed/Refractory
Chronic Lymphocytic Leukemia 

Matthew
S. Davids  

Abstract #3083

Sunday, 11 December

CET / 19:00 EST)   

(Mon 12 Dec 00:00 GMT / 01:00 CET/ 19:00 EST) 

 

Nature of Clinical Response and Depth of Molecular
Response In Patients With TP53 Mutant Myelodysplastic Syndromes (MDS) and
Acute Myeloid Leukemia (AML) Treated With Magrolimab With Azacitidine 

Lisa
Johnson

 

Mantle Cell & Follicular
Lymphomas

 

Abstract #2038  

Saturday, 10 December  

(22:30 GMT / 22:30 CET / 17:30 EST) 

 

A 3-Year Follow-up Comparison of Clinical Outcomes
from ZUMA-5 (Axicabtagene Ciloleucel) and the International SCHOLAR-5
External Control Cohort in Relapsed/Refractory Follicular Lymphoma (R/R FL)  

Paola
Ghione  

Abstract #1581  

Saturday, 10 December  

(22:30 GMT / 23:30 CET / 17:30 EST) 

 

Chimeric Antigen Receptor T-Cell Therapy Setting of
Care: A Retrospective Cohort Analysis of MCL and FL Patients in the US 

Roxana
Seyedin  

Abstract
#4861  

Monday, 12 December  

(23:00 GMT / 18:00 EST/ Tuesday,13 Dec 00:00 CET) 

 

Cost-effectiveness of Axi-Cel for Adult Patients
with Relapsed or Refractory Follicular Lymphoma in the United States 

Olalekan
Oluwole  

Abstract
#4660  

Monday, 12 December  

(23:00 GMT / 18:00 EST/ Tuesday, 13 Dec 00:00 CET) 

 

3-Year 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) 

Sattva
Neelapu  

Other Notable Data 

Abstract #165  

Saturday, 10 December  

(17:30 GMT / 18:30 CET / 12:30 EST) 

  

Targeting CNS Lymphoma with Intravenous Axi-Cel:
Evidence for Transcriptional Evolution Towards a Prominent Interferon
Signature in CAR-T Cells Trafficking to the Tumor Site 

Ulrike
Gerdemann  

Abstract #1981  

Saturday, 10 December  

(22:30 GMT / 23:30 CET / 17:30 EST) 

 

Identification of IL-4 as a Key Regulator of CAR
T-Cell Exhaustion Using Functional Genomics and Correlates of the Zuma-1
Clinical Trial  

Carly
Stewart 

Abstract #2039  

Saturday, 10 December  

(22:30 GMT / 23:30 CET / 17:30 EST) 

 

Baseline CRP and Ferritin Identify Patients at High
Risk of Poor Outcomes after Axicabtagene Ciloleucel Despite Corticosteroid
Prophylaxis  

Rawan
Faramand 

Abstract #4610  

Monday, 12 December  

(23:00 GMT / 18:00 EST/ Tuesday, 13 Dec 00:00 CET) 

 

Immunosuppressive Monocyte Modulation of CAR T Cell
Functions and Impact on Response to CART19 

Kun Yun 

Abstract
#4284  

Monday, 12 December  

(23:00 GMT / 18:00 EST/ Tuesday, 13 Dec 00:00 CET) 

 

Patients of Minority Race or Ethnicity in the US
Receiving CAR T-cell Therapy in Clinical Trials and in the Real-world: A
SEER-based Simulation  

Mendel
Goldfinger  

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