Breaking News
July 17, 2018 - Advanced MRI technique predicts risk of disease progression in MS
July 17, 2018 - Health Tip: Microwave Safely – Drugs.com MedNews
July 17, 2018 - New target for treating heart failure identified
July 17, 2018 - Biodesign fellows simplify heart rhythm monitoring
July 17, 2018 - Study reveals new risk genes for allergic rhinitis
July 17, 2018 - Community college education can increase physician diversity and access to primary care
July 17, 2018 - Inflection Biosciences’ dual mechanism inhibitor shows promise as treatment for CLL
July 17, 2018 - Researchers uncover how cells invite corrupted proteins inside
July 17, 2018 - Studies show HORIBA’s new hematology analyzer improves POCT and care of oncology patients
July 17, 2018 - New website aims to make yoga safer for everyone
July 17, 2018 - Long-term survival worse for black survivors of in-hospital cardiac arrest
July 17, 2018 - Stanford data analyst’s childhood inspires his research: A Q&A
July 17, 2018 - Preventability of hospital readmissions changes over time, study reveals
July 17, 2018 - Nursing notes can help predict if ICU patients will survive
July 17, 2018 - Okayama University research could improve prognosis of diabetic kidney disease
July 17, 2018 - Homogenous BTK occupancy assay used in tirabrutinib clinical studies
July 17, 2018 - Study identifies new genes linked to heart function and development
July 17, 2018 - NeuroTrauma Sciences and Henry Ford join hands to advance exosome technology
July 17, 2018 - Improved methods to measure enterococci concentrations in recreational water
July 17, 2018 - White adolescent boys experiencing early puberty have high risk for substance use
July 17, 2018 - Celgene and Acceleron Announce Luspatercept Achieved Primary and All Key Secondary Endpoints in Phase III ‘BELIEVE’ Study in Adults with Transfusion-Dependent Beta-Thalassemia
July 17, 2018 - Roots of leukemia reveal possibility of predicting people at risk
July 17, 2018 - Summer med program embraces low-income students’ potential
July 17, 2018 - New research lays foundation to create standards for RNA sequencing
July 17, 2018 - CRISPR/Cas9 gene editing can cause greater genetic damage than previously thought
July 17, 2018 - Democrats rally against threats to the ACA to block Trump’s Supreme Court nominee
July 17, 2018 - Staggering prices slow insurers’ coverage of CAR-T cancer therapy
July 17, 2018 - How proteins involved in neurodegeneration enter cells
July 17, 2018 - New super-resolution ‘nanoscope’ provides insight into progression of Alzheimer’s disease
July 17, 2018 - FDA Advisory Committee Endorses the Effectiveness and Safety of Single-Dose Tafenoquine for the Radical Cure of P. vivax Malaria
July 17, 2018 - Uncovering the evolutionary history of IBD-associated colorectal cancer
July 17, 2018 - Is nutrition research dependable? Stanford’s John Ioannidis weighs in
July 17, 2018 - New machine learning framework predicts effects of genetic mutations in ‘dark matter’ regions
July 17, 2018 - Plant-based products fail to have positive impact on blood pressure during clinical studies
July 17, 2018 - Electronic system to speed up facial pain diagnosis may improve quality of life and save money
July 17, 2018 - Study delves into the role played by Protein Kinase C in synaptic plasticity
July 17, 2018 - Women Often Unaware of Their Hospital’s Religious Affiliation
July 17, 2018 - New AASM guideline recommends use of actigraphy for sleep disorders
July 17, 2018 - CRISPR editing reduces repetitive behavior in mice with a form of autism
July 17, 2018 - Scientists use magnets to detect cancer
July 17, 2018 - Microfluidic chip to detect sepsis proves successful in clinical study
July 17, 2018 - Research provides better understanding of mechanisms underlying memory storage
July 17, 2018 - A Multi-Modal Approach for the Early Detection of Breast Cancer
July 17, 2018 - Mailing colorectal cancer tests to patients increases screening rates, report researchers
July 17, 2018 - Scientists find possible sources of medicinal and antimicrobial drugs
July 17, 2018 - Molecules formed when the body metabolizes omega-3 fatty acids may inhibit cancer
July 17, 2018 - Efficient communication between hospitals improves patient safety and reduces mortality
July 17, 2018 - Study highlights potential of fetal gene therapy to prevent lethal neurodegenerative disease
July 17, 2018 - For Americans, in Science They Trust
July 17, 2018 - Combating HIV/AIDS | NIH MedlinePlus the Magazine
July 17, 2018 - Study shows minorities widely underrepresented in autism diagnoses
July 17, 2018 - Multigene testing replacing BRCA tests for breast cancer risk | News Center
July 17, 2018 - Pre-clinical pilot study shows promising results of ‘concussion pill’
July 17, 2018 - Researchers reduce size of tumors in mice by artificially activating the brain’s reward system
July 17, 2018 - New study documents symptoms of people before they acquire multiple sclerosis
July 17, 2018 - Researchers discover why CRISPR gene editing sometimes fails
July 17, 2018 - New finding may hold key to better understand the complexities of neurological disorders
July 17, 2018 - The Current issue of “The view from here” is concerned with Novel Targets.
July 17, 2018 - Fighting the Flu with a Universal Vaccine
July 17, 2018 - Key social reward circuit in the brain impaired in kids with autism | News Center
July 17, 2018 - Insight into causes, types and treatment of aphasia
July 16, 2018 - Quark Pharmaceuticals, Inc Announces First Patient Dosed in Phase 3 Clinical Trial of QPI-1002 for Prevention of Acute Kidney Injury Following Cardiac Surgery
July 16, 2018 - NSAIDs shown to have causal role in cardiovascular risk of patients with osteoarthritis
July 16, 2018 - PET scan tracer predicts success of cancer ‘vaccine’ | News Center
July 16, 2018 - Parents struggle with what to do when their child has headache, shows study
July 16, 2018 - Outrageous or overblown? HHS announces another round of ACA navigator funding cuts
July 16, 2018 - Weight loss surgery may impact individual’s risk of developing cancer, shows study
July 16, 2018 - Alexion Submits Application for Priority Review and Approval of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the U.S.
July 16, 2018 - Restoring epigenetic balance reinstates memory in flies with Alzheimer’s disease symptoms
July 16, 2018 - Magnetized wire could be used to detect cancer in people | News Center
July 16, 2018 - Non-surgical management found to be feasible option for penetrating kidney trauma
July 16, 2018 - California clinic screens asylum seekers for honesty
July 16, 2018 - FDA Approves Xtandi (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)
July 16, 2018 - Can nanotechnology help treat Alzheimer’s?
July 16, 2018 - Researchers identify protein essential for making stem cells | News Center
July 16, 2018 - Severe childhood infections linked with lower school achievement in adolescence
July 16, 2018 - Radiologist discusses causes, treatments of varicose veins
July 16, 2018 - Researchers develop nanostructured surface to accelerate wound healing after dental implants
July 16, 2018 - New non-invasive procedure to reposition kidney stones could benefit astronauts
July 16, 2018 - Attending Surgeon Influences Genetic Testing in Breast Cancer
Kite Announces Data From ZUMA-3 Study of KTE-C19 in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia

Kite Announces Data From ZUMA-3 Study of KTE-C19 in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia

image_pdfDownload PDFimage_print

ATLANTA–(BUSINESS WIRE)–Dec. 11, 2017– Kite, a Gilead Company (Nasdaq: GILD), announced updated results from the ongoing Phase 1/2 ZUMA-3 study of KTE-C19, a CD19 chimeric antigen receptor T (CAR T) cell therapy, which is investigational for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL). With a minimum of eight weeks of follow-up, 71 percent of ALL patients (n=17/24) who received a single infusion of KTE-C19 achieved complete tumor remission (complete remission (CR) or CR with incomplete hematological recovery). The ZUMA-3 study results were presented in an oral session at the Annual Meeting of the American Society of Hematology (ASH) in Atlanta.

ALL is an aggressive type of blood cancer which can also involve the lymph nodes, spleen, liver, central nervous system and other organs.

“Approximately half of new ALL cases occur in adults age 20 or older and a majority of adult ALL patients relapse and have poor subsequent outcomes,” said Bijal Shah, MD, ZUMA-3 investigator and medical oncologist, Moffitt Cancer Center, Tampa, Fla. “The deep remissions seen with these early study results offer promise that adults with this aggressive disease may benefit from personalized cell therapy with KTE-C19. Pending further clinical evaluation, this has the potential to be an advance for adults with no other treatment options.”

ZUMA-3 is an ongoing multicenter Phase 1/2 study in patients with ALL whose disease is refractory to or has relapsed following standard chemotherapy or hematopoietic stem cell transplantation. The objectives of the study are to evaluate the safety and efficacy of KTE-C19 in this patient population.

At the time of data cutoff, 24 patients were evaluable for response. KTE-C19 demonstrated a 71 percent (n=17/24) rate of complete remission, with 100 percent of responders having no detectable minimal residual disease, including in those with high tumor burden and high risk genetic abnormalities.

In the safety analysis of 29 patients, adverse events were consistent with the known toxicities of CD19 CAR T treatment, including Grade 3 or higher cytokine release syndrome (CRS) and neurologic toxicities in 28 percent (n=8/29) and 52 percent of patients (n=15/29), respectively. Two patients receiving KTE-C19 died due to adverse events, including one patient with a cerebrovascular accident not related to KTE-C19 treatment approximately seven weeks after treatment and a previously reported patient who experienced fatal CRS.

“We believe personalized cell therapy has the potential to become a cornerstone of cancer treatment and are rapidly advancing CAR T studies in ALL and in other cancers,” said David Chang, MD, PhD, Worldwide Head of Research and Development and Chief Medical Officer at Kite. “ZUMA-3 is reflective of our continued commitment to cell therapy cancer treatment and we are pleased to see these early results for people living with ALL.”

KTE-C19 for ALL is investigational and has not been proven safe or efficacious.

About Kite

Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. 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. For more information on Kite, please visit www.kitepharma.com.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 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 risk that future clinical trials involving KTE-C19 may have unfavorable results. As a result, KTE-C19 may not be commercialized for ALL or other investigational indications. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include risks and uncertainties detailed from time to time in Gilead Sciences, Inc.’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017 as filed with the 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 and disclaim any intent to update any such forward-looking statements.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Source: Gilead Sciences

Posted: December 2017

Tagged with:

About author

Related Articles