On May 17, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, reported that more than 20 abstracts, including two oral presentations and four poster discussions, will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Gilead Sciences, MAY 17, 2022, View Source [SID1234614761]). These data highlight promising targets across diverse tumor types and blood cancers, including hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer, metastatic triple-negative breast cancer (TNBC), large B-cell lymphoma (LBCL), myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and mantle cell lymphoma (MCL).
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"Gilead has built a diverse oncology pipeline guided by our strategic framework, with a focus on depth and breadth to address the greatest gaps in care for people with overlooked, underserved and difficult-to-treat cancers," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "Anchored by our Trop-2 directed antibody-drug conjugate, CAR T-cell therapies and our investigational anti-CD47 antibody, these data reinforce the potential of our transformative science across multiple cancers."
Driving Scientific Innovation in Breast Cancers with High Unmet Need
A late-breaking presentation on the TROPiCS-02 study will examine the investigational use of Gilead’s antibody-drug conjugate in heavily pre-treated patients with HR+/HER2- unresectable locally advanced or metastatic breast cancer, a population with significantly limited treatment options following endocrine resistance. The final data from the landmark ASCENT study in second-line metastatic TNBC will also be presented.
Advancing an Industry-Leading CAR T-cell Therapy Portfolio
New analyses of the Phase 3 ZUMA-7 trial will highlight results in patients aged 65+, as well as data on pre-treatment tumor burden characteristics and clinical outcomes for the first and only CAR T-cell therapy approved for initial treatment of relapsed/refractory LBCL. Additional presentations include real-world outcomes by race and ethnicity for Kite’s CAR T-cell therapy in LBCL and longer-term data from the ZUMA-2 and ZUMA-3 studies assessing the durability of response to Kite’s CAR T-cell therapy in relapsed/refractory MCL and relapsed/refractory adult ALL, respectively.
"At Kite, our singular focus is on developing cell therapies to treat and potentially cure cancers," said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development. "Our data at ASCO (Free ASCO Whitepaper) span multiple types of blood cancer and stages of treatment, reinforcing how our therapies are changing the way cancer is treated."
Furthering Potential Treatment Approaches in MDS and AML
Results of our Phase 1b study evaluating an investigational anti-CD47 antibody in combination with azacitidine in high-risk MDS and in TP53-mutant AML will be presented. MDS and AML are blood cancers which have seen limited therapeutic advancements in the past decade, and Gilead data being presented at ASCO (Free ASCO Whitepaper) will reinforce the potential of harnessing the innate immunity of macrophages.
Summary of Presentations
Accepted abstracts at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting include (all times CDT):
Abstract Disposition
Abstract Title
Breast Cancer
Abstract #LBA1001 (Oral Session)
Saturday, June 4
1:27 PM
Primary Results from TROPiCS-02: A Randomized Phase 3 Study of Sacituzumab Govitecan (SG) versus Treatment of Physician’s Choice (TPC) in Patients with Hormone Receptor-Positive/HER2-Negative (HR+/HER2-) Advanced Breast Cancer
Abstract #1071
Monday, June 6
8:00 AM
Sacituzumab Govitecan (SG) versus Treatment of Physician’s Choice (TPC) in Patients with Previously Treated Metastatic Triple-Negative Breast Cancer (mTNBC): Final Results from the Phase 3 ASCENT Study
Abstract #1076
Monday, June 6
8:00 AM
Exposure-Response Analyses of Sacituzumab Govitecan (SG) Efficacy and Safety in Patients with Metastatic Triple-Negative Breast Cancer (mTNBC)
Abstract #1075
Monday, June 6
8:00 AM
Real-World Treatment Patterns and Outcomes among 2nd Line (2L) and 3rd Line (3L) Metastatic Triple-Negative Breast Cancer (mTNBC) Patients in England Using the Cancer Analysis System (CAS)
Myelodysplastic Syndrome
Abstract #7017 (Poster Discussion)
Saturday, June 4
1:15 PM
Magrolimab in Combination with Azacitidine for Untreated Higher-Risk Myelodysplastic Syndromes (HR-MDS): 5F9005 Phase 1b Study Results
Abstract #7054
Saturday, June 4
8:00 AM
Impact of Magrolimab Treatment in Combination with Azacitidine on Red Blood Cells in Higher-Risk Myelodysplastic Syndrome (HR-MDS) Patients
ePublication #e19062
Clinical Outcomes Associated with Azacitidine Monotherapy for Treatment-Naïve Higher-Risk Myelodysplastic Syndrome: A Systematic Literature Review and Meta-Analysis
Acute Myeloid Leukemia
Abstract #7020 (Poster Discussion)
Saturday, June 4
1:15 PM
Tolerability and Efficacy of the First-in-Class Anti-CD47 Antibody Magrolimab Combined with Azacitidine in Frontline TP53m AML Patients: Phase 1b Results
ePublication #e19020
Treatment Outcomes for Newly Diagnosed, Untreated TP53-Mutated Acute Myeloid Leukemia: A Systematic Review and Meta-Analysis
B-cell Lymphomas
Abstract #7571 (Oral Session)
Friday, June 3
3:12 PM
Real-World Outcomes of Axicabtagene Ciloleucel (Axi-Cel) for the Treatment of Large B-cell Lymphoma (LBCL) by Race and Ethnicity
Abstract #7548
Saturday, June 4
8:00 AM
Clinical and Patient-Reported Outcomes (PROs) in a Phase 3, Randomized, Open-Label Study Evaluating Axicabtagene Ciloleucel (Axi-Cel) versus Standard-of-Care (SOC) Therapy in Elderly Patients with Relapsed/Refractory (R/R) Large B-cell Lymphoma (LBCL) (ZUMA-7)
Abstract #7565
Saturday, June 4
8:00 AM
Association of Pretreatment (Pretx) Tumor Characteristics and Clinical Outcomes Following Second-Line (2L) Axicabtagene Ciloleucel (Axi-Cel) versus Standard of Care (SOC) in Patients with Relapsed/Refractory (R/R) Large B-cell Lymphoma (LBCL)
Abstract #7567
Saturday, June 4
8:00 AM
Axicabtagene Ciloleucel (Axi-Cel) in Combination with Rituximab (Rtx) for the Treatment of Refractory Large B-cell Lymphoma (R-LBCL): Outcomes of the Phase 2 ZUMA-14 Study
Abstract #7555
Saturday, June 4
8:00 AM
Quality-Adjusted Time without Symptoms or Toxicities (Q-Twist) Analysis of ZUMA-7, a Randomized Controlled Trial of Axicabtagene Ciloleucel versus Standard of Care for Second-Line Large B-cell Lymphoma
Abstract #TPS7579
Saturday, June 4
8:00 AM
KITE-363: A Phase 1 Study of an Autologous Anti-CD19/CD20 Chimeric Antigen Receptor (CAR) T-Cell Therapy in Patients with Relapsed/Refractory (R/R) B-cell Lymphoma (BCL)
ePublication #e19558
Patient Preferences for Second-Line Treatment Options in Diffuse Large B-cell Lymphoma: A Discrete Choice Experiment
Mantle Cell Lymphoma
Abstract #7518 (Poster Discussion)
Saturday, June 4
3:00 PM
Three-Year Follow-Up of Outcomes with KTE-X19 in Patients with Relapsed/Refractory Mantle Cell Lymphoma in ZUMA-2
Acute Lymphoblastic Leukemia
Abstract #7010 (Poster Discussion)
Saturday, June 4
1:15 PM
Two-Year Follow-Up of KTE-X19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy, in Adult Patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL) in ZUMA-3
Non-Small Cell Lung Cancer
Abstract #TPS9149
Monday, June 6
8:00 AM
EVOKE-01: A Phase 3 Study of Sacituzumab Govitecan (SG) versus Docetaxel in Patients with Non-Small Cell Lung Cancer (NSCLC) Progressing On or After Platinum-Based Chemotherapy and Checkpoint Inhibitors
Abstract #TPS9146
Monday, June 6
8:00 AM
EVOKE-02: A Phase 2 Study of Sacituzumab Govitecan Plus Pembrolizumab with or without Platinum Chemotherapy in First-Line Metastatic Non-Small Cell Lung Cancer (NSCLC)
Advanced Solid Tumors
Abstract #2566
Sunday, June 5
8:00 AM
Phase 1b Study of GS-3583, A Novel FLT3 Agonist Fc Fusion Protein, in Patients with