Sources for CAR-T Cell Therapy HCP Guide by Drugs.com

Studies

— Ahmed N, Brawley V, Hegde M, et al. Human epidermal growth factor receptor 2 (HER2)-specific chimeric antigen receptor-modified T cells for the immunotherapy of HER2-positive sarcoma. J Clin Oncol. 2015;1688–96.

— Alamasbak H, Aarvak T, Vemuri M, et al. CAR T Cell Therapy: A Game Changer in Cancer Treatment. J of Immunology Research. 2016: Article ID: 5474602 https://www.hindawi.com/journals/jir/2016/5474602/

— Au R. Immunooncology: Can the Right Chimeric Antigen Receptors T-Cell Design Be Made to Cure All Types of Cancers and Will It Be Covered? J Pharm (Cairo). 2017;2017:7513687. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5292386

— Bernaski R. Looking Ahead: What’s New In CAR T-Cell Therapy for Hematologic Malignancies. Cure. March 24, 2017. https://www.curetoday.com/articles/looking-ahead-whats-new-in-cart-cell-therapy-for-hematologic-malignancies#sthash.wc2O8TXw.dpuf

— Carroll J. Lethally severe neurotoxicity continues to haunt Juno’s CAR-T pipeline. Endpoint News. December 3, 2016. https://endpts.com/lethally-severe-neurotoxicity-continues-to-haunt-junos-car-t-pipeline/

— Carroll J. Prepping for a rapid-fire launch, Kite Pharma gets a pass from FDA on axi-cel panel review. Endpoints News. August 8, 2017. https://endpts.com/fda-hands-kite-pharma-a-pass-on-axi-cel-panel-review-car-t-ready-to-launch/

— Carroll J. One of Kite Pharma’s CAR-T patients died from cerebral edema, triggering a safety alarm. Endpoint News. May 8, 2017. https://endpts.com/one-of-kites-car-t-patients-died-from-cerebral-edema-triggering-a-safety-alarm/

— Carroll J. With One BLA at the FDA, Kite hustles along impressive new leukemia data and sounds a note of caution on safety. Endpoints News. July 11, 2017. https://endpts.com/with-one-bla-at-the-fda-kite-hustles-along-impressive-new-leukemia-data-and-sounds-a-note-of-caution-on-safety/

— Connolly JL, Schnitt SJ, Wang HH, et al. Tumor Structure and Tumor Stroma Generation. In: Kufe DW, Pollock RE, Weichselbaum RR, et al., editors. Holland-Frei Cancer Medicine. 6th edition. Hamilton (ON): BC Decker; 2003. https://www.ncbi.nlm.nih.gov/books/NBK13447/

— Crump M, Neelapu SS, Farooq U, et al. Outcomes in refractory aggressive diffuse large B-cell lymphoma (DLBCL): results from the international SCHOLAR-1 study. Presented at: the 2016 American Society of Clinical Oncology Annual Meeting; Chicago, Illinois; June 3-7, 2016. Abstract 7516.

— Feinberg F, Fillman J, Simoncini J, et al. CAR-T Cells: The Next Era in Immuno-Oncology. AJMC.com. Feb 14, 2017. https://www.ajmc.com/journals/evidence-based-oncology/2017/february-2017/car-t-cells-the-next-era-in-immuno-oncology-/P-4

— Harris J. OncLive. Kite Reports Cerebral Edema Death in ZUMA-1 CAR T-Cell Trial. May 8, 2017. https://www.onclive.com/web-exclusives/kite-reports-cerebral-edema-death-in-zuma1-car-tcell-trial?p=1

— Howard S, Jones D, Ching-Hon P. The Tumor Lysis Syndrome. N Engl J Med. 2011 May 12; 364(19): 1844–1854. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3437249/

— Kakarla S, Gottschalk S. CAR T Cells for Solid Tumors: Armed and Ready to Go? Cancer J. 2014; 20:151-55. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4050065/

— Kochenderfer JN, Rosenberg SA. Treating B-cell cancer with T cells expressing anti-CD19 chimeric antigen receptors. Nat Rev Clin Oncol. 2013;10(5):267-76. https://www.ncbi.nlm.nih.gov/pubmed/23546520

— Kochenderfer JN, Dudley ME, Kassim SH, et al. Chemotherapy-refractory diffuse large B-cell lymphoma and indolent B-cell malignancies can be effectively treated with autologous T cells expressing an anti-CD19 chimeric antigen receptor. J Clin Oncol. 2015;33(6):540-549. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4322257/

— Kwon D. What do the CAR-T Patient Deaths Mean for the Future of the Field? Labiotech.eu. https://labiotech.eu/cart-patient-deaths-juno

— Locke FL, Neelapu SS, Bartlett NL, et al. Phase 1 results of ZUMA-1: a multicenter study of KTE-C19 anti-CD19 CAR T-cell therapy in refractory aggressive lymphoma. Mol Ther. 2017;25(1):285-95. https://www.cell.com/molecular-therapy-family/molecular-therapy/references/S1525-0016(16)45375-X

— Louis C, Savoldo B, Dotti G, et al. Antitumor activity and long-term fate of chimeric antigen receptor-positive T cells in patients with neuroblastoma. Blood 2011:118; 6050–56.

— Mandal A. Cancer Pathophysiology. News Medical. Accessed April 12, 2017 at https://www.news-medical.net/health/Cancer-Pathophysiology.aspx

— Maus M, Levine B. Chimeric antigen receptor T-cell therapy for the community oncologist. The Oncologist 2016;21:1-10. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4861363/

— Morgan R, Yang J, Kitano M, et al. Case Report of a Serious Adverse Event Following the Administration of T Cells Transduced With a Chimeric Antigen Receptor Recognizing ERBB2. Mol Ther. 2010 Apr; 18(4): 843–851. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2862534/

— Neelapu S. An Interim Analysis of the ZUMA-1 Study of KTE-C19 in Refractory, Aggressive Non-Hodgkin Lymphoma. Clinical Advances in Hematology & Oncology. Vol. Volume 15, Issue 2, February 2017. https://www.hematologyandoncology.net/index.php/archives/february-2017/an-interim-analysis-of-the-zuma-1-study-of-kte-c19-in-refractory-aggressive-non-hodgkin-lymphoma/

— Newick K, Moon E, Albelda S. Chimeric antigen receptor T-cell therapy for solid tumors. Molecular Therapy Oncolytics. Volume 3, 2016, Article 16006. https://www.sciencedirect.com/science/article/pii/S2372770516300456

— Ramaswami R. NEJM Resident360. Regression of Glioblastoma after Chimeric Antigen Receptor T-Cell Therapy. https://resident360.nejm.org/content_items/2119/

— Shah B, Castro J, Gokbuget N, et al. ZUMA-3: A phase 1/2 multi-center study evaluation the safety and efficacy of KTE-C19 anti-CD19 CAR T cells in adult patients with relapsed/refractory B precursor acute lymphoblastic leukemia (R/R ALL). Ann Oncol (2016) 27 (suppl_6): 415TiP. https://academic.oup.com/annonc/article-abstract/27/suppl_6/415TiP/2799154/ZUMA-3-A-phase-1-2-multi-center-study-evaluation

— Sharpe M, Mount N. Genetically modified T cells in cancer therapy: opportunities and challenges. Dis Model Mech. 2015;8(4):337-350. https://dmm.biologists.org/content/8/4/337

— Shoushtari A, Snyder Charen A, Postow A, et al. Up to Date: Principles of Cancer Immunotherapy. https://www.uptodate.com/contents/principles-of-cancer-immunotherapy

— Smith AD. Pivotal Year Looms for CAR T-Cell Therapies. OncLive. March 1, 2017. https://www.onclive.com/publications/oncology-live/2017/vol-18-no-4/pivotal-year-looms-for-car-tcell-therapies

— Wang M, Locke F, Siddiqi T, et al. ZUMA-2: A phase 2 multi-center study evaluating the efficacy of KTE-C19 (Anti-CD19 CAR T cells) in patients with relapsed/refractory Mantle cell lymphoma (R/R MCL). Ann Oncol (2016) 27 (suppl_6): 945TiP. https://academic.oup.com/annonc/article-abstract/27/suppl_6/945TiP/2799682/ZUMA-2-A-phase-2-multi-center-study-evaluating-the?redirectedFrom=fulltext

— Wang X. Riviere I. Clinical manufacturing of CAR T cells: foundation of a promising therapy. Molecular Therapy Oncolytics. 2016;3:16015; doi:10.1038/mto.2016.15; published online 15 June 2016. https://www.sciencedirect.com/science/article/pii/S2372770516300390

— Wei G, Ding L, Wang J, et al. Advances of CD19-directed chimeric antigen receptor-modified T cells in refractory/relapsed acute lymphoblastic leukemia. Exp Hematol Oncol. 2017; 6: 10. Published online 2017 Apr 14. doi: 10.1186/s40164-017-0070-9 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5391552/

— Weintraub, A. How to cover Novartis’ $475K CAR-T drug Kymriah? A ‘new payment model’ is the only way, Express Scripts says. FiercePharma. Sep 22, 2017. https://www.fiercepharma.com/financials/car-t-and-other-gene-therapies-need-new-payment-model-says-express-scripts

— Yong, C, Dardalhon V, Devaud C, et al. CAR T-cell therapy of solid tumors. Immunology and Cell Biology. 2017. https://www.nature.com/icb/journal/v95/n4/full/icb2016128a.html

— Yong C, Dardalhon V, Devaud C, et al. CAR T-cell therapy of solid tumors. Immunology and Cell Biology. Immunology and Cell Biology (22 December 2016) | doi:10.1038/icb.2016.128. https://www.nature.com/icb/journal/vaop/ncurrent/full/icb2016128a.html

— Zhang T, Cao L, Xie J, et al. Efficiency of CD19 chimeric antigen receptor-modified T cells for treatment of B cell malignancies in phase I clinical trials: a meta-analysis. Oncotarget. 2015 Oct 20; 6(32):33961-71. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4741817/

Articles, Press Releases, Websites

— Adam B. Kite Pharma’s CAR-T drug begins LA hospital trial in children. FierceBiotech. May 2, 2016. https://www.fiercebiotech.com/biotech/kite-pharma-s-cart-drug-begins-la-hospital-trial-children

— American Cancer Society. Why Are Stem Cell Transplants Used as Cancer Treatment? https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/stem-cell-transplant/why-stem-cell-transplants-are-used.html

— American Pharmacy News. ZUMA-6 clinical trial enrolls first patient. Oct. 14, 2016. https://americanpharmacynews.com/stories/511017051-zuma-6-clinical-trial-enrolls-first-patient

— Beyond the Dish: CAR Immune Cells to Treat Childhood Cancers – October 2014. https://beyondthedish.wordpress.com/tag/car-t-cells/

— Cancer.net. Lymphoma: Non-Hodgkin: Subtypes. https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes

— CAR T-Cell Therapy: Engineering Patients’ Immune Cells to Treat Their Cancers. National Cancer Institute (NCI). https://www.cancer.gov/about-cancer/treatment/research/car-t-cells

— Cell Press. CAR T cell therapy can now target solid tumors: Mouse study. ScienceDaily. ScienceDaily, 21 June 2016. www.sciencedaily.com/releases/2016/06/160621132523.htm

— Centers for Disease Control and Prevention (CDC). Human Papillomavirus (HPV) and Cancer. Reviewed May 17, 2017. https://www.cdc.gov/cancer/hpv/index.htm

— Chimeric Antigen Receptor–Directed Natural Killer Cells for B Cell Malignancies. MD Anderson Cancer Center. OncoLog, May-June 2017, Volume 62, Issue 5-6. https://www.mdanderson.org/publications/oncolog/may-june-2017/chimeric-antigen-receptordirected-natural-killer-cells-for-b-cel.html?cmpid=linkedin_oncolog_immunotherapy_clinicaltrials_lymphoma

— Clinical Oncology News. How I Manage: Transformed Follicular Lymphoma. https://www.clinicaloncology.com/Hematologic-Malignancies/Article/11-15/How-I-Manage-Transformed-Follicular-Lymphoma/34232/ses=ogst

— ClinicalTrials.gov. A multi-center study evaluating KTE-C19 in pediatric and adolescent subjects with relapsed/refractory B-precursor acute lymphoblastic leukemia (ZUMA-4). https://clinicaltrials.gov/ct2/show/NCT02625480. Identifier: NCT02625480.

— ClinicalTrials.gov. A phase 2 multicenter study evaluating subjects with relapsed/refractory mantle cell lymphoma (ZUMA-2). https://clinicaltrials.gov/ct2/show/NCT02601313. Identifier: NCT02601313.

— ClinicalTrials.gov. A study evaluating KTE-C19 in adult subjects with relapsed/refractory B-precursor acute lymphoblastic leukemia (r/r ALL) (ZUMA-3). https://clinicaltrials.gov/ct2/show/NCT02614066. Identifier: NCT02614066.

— ClinicalTrials.gov. A study evaluating KTE-C19 in combination with atezolizumab in subjects with refractory diffuse large B-cell lymphoma (DLBCL) (ZUMA-6). https://clinicaltrials.gov/ct2/show/NCT02926833. Identifier: NCT02926833.

— Discover Cart T (online). Kite Pharma. https://www.discovercart.com/why-car-t/

— Kite Announces Positive Topline Primary Results of Axicabtagene Ciloleucel from First Pivotal CAR-T Trial in Patients with Aggressive Non-Hodgkin Lymphoma. Clinical Trials. Drugs.com. February 28, 2017. https://www.drugs.com/clinical_trials/kite-announces-positive-topline-primary-results-axicabtagene-ciloleucel-first-pivotal-car-t-trial-17392.html

— Kite Completes Submission of U.S. Biologics License Application (BLA) for Axicabtagene Ciloleucel as the First CAR-T Therapy for the Treatment of Patients With Aggressive Non-Hodgkin Lymphoma (NHL). Clinical Trials. Drugs.com. March 31, 2017. https://www.drugs.com/nda/kte_c19_170331.html

— Kite Highlights Durable Complete Remissions Up to 56+ Months in Patients with Chemorefractory Aggressive Non-Hodgkin Lymphoma (NHL) after Anti-CD19 CAR T-Cell Therapy at the National Cancer Institute. Press Release. Kite Pharma. July 20, 2017. https://www.drugs.com/clinical_trials/kite-highlights-durable-complete-remissions-up-56-months-patients-chemorefractory-aggressive-non-17554.html

— Kite Highlights Publication from the National Cancer Institute Demonstrating Responses in Patients with Metastatic Solid Tumors Treated with T Cell Receptor (TCR) Therapy Targeting MAGE A3. Press Release. Kite Pharma. August 17, 2017. https://ir.kitepharma.com/releasedetail.cfm?ReleaseID=1037572

— Kite Highlights Publication on Breakthrough in Generating Fully Functioning T Cells from Hematopoietic Precursor Cells by Leading Researchers at the University of California, Los Angeles (UCLA). Press Release. https://ir.kitepharma.com/releasedetail.cfm?releaseid=1020052

— Kite Pharma. CAR T-cell Technology. https://kitepharma.com/technology/#car_t

— Kite Pharma. Pipeline. https://kitepharma.com/pipeline/

— Kite Pharma Announces Clinical and Manufacturing Updates on KTE-C19 and MAGE-A3 Product Candidates at the Annual Meeting of the American Association for Cancer Research (AACR). March 16, 2016. https://ir.kitepharma.com/releasedetail.cfm?ReleaseID=961028

— Kite Pharma Details KTE-C19 Launch Preparedness and Near-Term, Next Generation CAR/TCR Product Candidates at Investor Day. Press Release. Kite Pharma. October 19, 2016. https://ir.kitepharma.com/releasedetail.cfm?releaseid=994338

— Kite Pharma Expands Development of T-Cell Receptor (TCR) Therapies Targeting HPV-Associated Cancers in Partnership with the National Cancer Institute (NCI). Press Release. June 20, 2016. https://ir.kitepharma.com/releasedetail.cfm?releaseid=976295

— Kite Pharma Licenses Enabling Technology for the Development of Off-the-Shelf Allogeneic T-Cell Therapies. Press Release. https://ir.kitepharma.com/releasedetail.cfm?releaseid=981016

— Kite Pharma Initiates Phase 1b/2 Combination Study for KTE-C19 and Atezolizumab in Patients with Refractory Diffuse Large B-cell Lymphoma (DLBCL). Press Release. Kite Pharma. October 6, 2016. https://ir.kitepharma.com/releasedetail.cfm?releaseid=992426

— Kite Pharma Initiates Phase 2 Clinical Study of KTE-C19 (ZUMA-2) in Patients With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL) to Support Registration for a Second Indication. Press Release, Kite Pharma. March 9, 2015. https://ir.kitepharma.com/releasedetail.cfm?releaseid=941501

— Kite Pharma Receives FDA Breakthrough Therapy Designation for KTE-C19 for the Treatment of Refractory, Aggressive Non Hodgkin Lymphoma (NHL). Dec. 7, 2015. News Release. Kite Pharma. https://ir.kitepharma.com/releasedetail.cfm?releaseid=945790

— Kite Pharma Reports 73 Percent of Patients Achieved MRD Negative Complete Remission in Updated Analysis From Phase 1 ZUMA-3 CAR-T Trial of KTE-C19 in Adult Patients With High Burden Relapsed/Refractory Acute Lymphoblastic Leukemia. Press Release. Kite Pharma. June 5, 2017. Drugs.com. https://www.drugs.com/clinical_trials/kite-reports-73-percent-patients-achieved-mrd-negative-complete-remission-updated-analysis-phase-1-17535.html

— Kite Pharma Reports 82 Percent of Patients Achieved Complete Remission in Preliminary Analysis from Phase 1 ZUMA-3 and ZUMA-4 Trials of KTE-C19 in Adult and Pediatric Patients with High Burden Relapsed/Refractory Acute Lymphoblastic Leukemia. Clinical Trials. Drugs.com. Dec. 4, 2016. https://www.drugs.com/clinical_trials/kite-pharma-reports-82-percent-patients-achieved-complete-remission-preliminary-analysis-phase-1-17393.html

— Kite Pharma Submits Investigational New Drug (IND) Application for KITE-718, an Investigational Next Generation T-Cell Receptor (TCR) Therapy Targeting Cancer Antigens MAGE A3 and MAGE A6. Kite Pharma. Press Release. January 3, 2017. https://ir.kitepharma.com/releasedetail.cfm?releaseid=1005990

— Kite Submits Investigational New Drug (IND) Application for KITE-585, Anti-BCMA CAR-T Therapy Candidate for Multiple Myeloma. Drugs.com. August 8, 2017. https://www.drugs.com/clinical_trials/kite-submits-investigational-new-ind-application-kite-585-anti-bcma-car-t-therapy-candidate-17576.html

— KTE-C19 Approval Status. FDA Status. Drugs.com. https://www.drugs.com/history/kte-c19.html

— Leukemia and Lymphoma Society. Acute Lymphoblastic Leukemia. Treatment. https://www.lls.org/leukemia/acute-lymphoblastic-leukemia/treatment

— Leukemia and Lymphoma Society. Chimeric Antigen Receptor (CAR) T-Cell Therapy. https://www.lls.org/treatment/types-of-treatment/immunotherapy/chimeric-antigen-receptor-car-t-cell-therapy

— Leukemia and Lymphoma Society. Chimeric Antigen Receptor (CAR) T-Cell Therapy Fact Sheet. No. 27. https://www.lls.org/sites/default/files/National/USA/Pdf/Publications/FS27_CAR_T-Cell_FS_4_17_FINAL.pdf

— Leukemia and Lymphoma Society. Chimeric Antigen Receptor (CAR) T-Cell Therapy. https://www.lls.org/treatment/types-of-treatment/immunotherapy/chimeric-antigen-receptor-car-t-cell-therapy

— Leukemia and Lymphoma Society. NHL Subtypes. https://www.lls.org/lymphoma/non-hodgkin-lymphoma/diagnosis/nhl-subtypes

— National Cancer Institute (NCI). HPV and Cancer. Reviewed: February 19, 2015. https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-fact-sheet

— National Foundation for Transplants. How much does a transplant cost? https://www.transplants.org/faq/how-much-does-transplant-cost

— Targeted Cancer Therapies. National Cancer Institute (NIH). https://www.cancer.gov/about-cancer/treatment/types/targeted-therapies/targeted-therapies-fact-sheet

— T-Cell Therapy: Engineering Patients’ Immune Cells to Treat Their Cancers. National Cancer Institute (NCI). https://www.cancer.gov/about-cancer/treatment/research/car-t-cells

— The Genetics of Cancer. National Cancer Institute (NIH). April 2015. https://www.cancer.gov/about-cancer/causes-prevention/genetics

— What Are the Key Statistics About Acute Lymphocytic Leukemia? American Cancer Society. https://www.cancer.org/cancer/acute-lymphocytic-leukemia/about/key-statistics.html

— What is Cancer? National Cancer Institute (NIH). https://www.cancer.gov/about-cancer/understanding/what-is-cancer

— What is HLH? Cincinnati Children’s. https://www.cincinnatichildrens.org/service/h/hlh/about