Engineering an Immunity to Cancer: A New Era of Adoptive Cellular Therapy with Tisagenlecleucel (Kymriah) in Pediatric ALL

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1 Engineering an Immunity to Cancer: A New Era of Adoptive Cellular Therapy with Tisagenlecleucel (Kymriah) in Pediatric ALL Diana Schreier, Pharm.D., M.B.A. Pharmacy Grand Rounds October 17, MFMER slide-1

2 Objectives Define Chimeric Antigen Receptor (CAR) T-Cell Therapy and its role in the treatment of pediatric ALL Describe the process of engineering, administering and monitoring tisagenlecleucel treatment Review complications and management strategies for treatment-related adverse effects 2017 MFMER slide-2

3 Patient case JM is a 6 year old male brought in by his mother. She is very concerned that JM has been looking very pale recently and is covered in bruises. Upon further evaluation, JM s workup shows the following: lymphadenopathy, Hgb 7.4, leukocytes 6.3, plt 87, > 20% lymphoblasts on bone marrow biopsy 2017 MFMER slide-3

4 Question JM was diagnosed with ALL. What is the first line therapy for treating JM s leukemia? 1. Tisagenlecleucel (Kymriah) 2. Intensive chemotherapy followed by HSCT 3. HSCT without chemotherapy 4. Clinical trial 2017 MFMER slide-4

5 Phases of Pediatric ALL Treatment Remission induction: Achieve remission Consolidation/intensification: Eradicate remaining cancerous cells Extracompartment therapy: CNS-directed Maintenance: Suppress re-emergence Cooper et al. Pediatr Clin North Am. 2015; 62(1): National Comprehensive Cancer Network. Acute Lymphoblastic Leukemia (Version ). Accessed October 6, MFMER slide-5

6 Relapsed Pediatric ALL Treatment Relapses occur most frequently within 2 years of treatment completion Oftentimes patients undergo re-induction and consolidation to achieve 2 nd complete response Followed by allogeneic hematopoietic stem cell transplant (HSCT) Cure rate of 30%-50% after chemotherapy and allogeneic HSCT Cooper et al. Pediatr Clin North Am. 2015; 62(1): Inaba et al. Lancet. 2013;381(9881): Locatelli et al. Blood. 2012; 12(14): MFMER slide-6

7 Immuno-oncology Hallmark of cancer: Ability to avoid immune destruction Immunosurveillance Host recognizes and eliminates immunogenic tumors Novel therapies in immuno-oncology Check point antibodies (PDL-1, CTLA-4 inhibitors) Cytokine therapy (interleukins, interferons) Chimeric Antigen Receptor (CAR) T-cells Hanahan et al. Cell. 2011;100: Finn et al. Ann Oncol. 2012;23(8): vii6-vii MFMER slide-7

8 Immuno-oncology Unregulated tumor growth occurs when tumor subverts immune response 1. Loss of immunogenicity 2. Microenvironment with immunosuppressive cells Cancer cell 1 2 Cancer cell Cancer cell 2017 MFMER slide-8

9 Immunosurveillance mechanism Expansion and differentiation Cytotoxicity Cancer cell T cell Cytokine signaling Kymriah [package insert]. Novartis Pharmaceuticals Corporation. New Hanover, NJ; MFMER slide-9

10 Tisagenlecleucel mechanism Chimeric Antigen Receptor (CAR) T cells Autologous T-cells that have been genetically altered to express a diseaseassociated antigen ALL B cell Tisagenlecleucel Eshhar, Z et al. Proc Natl Acad Sci USA. 1993; 90(2): MFMER slide-10

11 Structure of tisagenlecleucel CAR Anti-CD19 scfv Transmembrane domain CD3ʓ signaling domain Costimulation signaling domain 41BB (CD137) Dahan R, Reiter Y. Expert Rev Mol Med. 2012; 14: e6. Kochenderfer JN et al. J Immunother. 2009; 32(7): MFMER slide-11

12 Treatment process Transport to manufacturer Final product Transduction Leukapheresis Administration Lymphodepleting chemotherapy 2017 MFMER slide-12

13 Tisagenlecleucel preparation Preparation and transduction with lentiviral vector The vector is self-inactivating Has not demonstrated signs of genotoxicity Lentiviral transduction with anti-cd19 CAR transgene Cavazzana et al. Hum Gene Ther. 2016;27: Hacein-Bey-Abina et al. JAMA. 2015; 313: Heinrich et al. Mol Ther. 2013;21: Li et al. Transl Med. 2010;8:104. Tisagenlecleucel (CTL019). FDA Advisory Committee Briefing Document MFMER slide-13

14 Cellular Expansion Utility of lymphodepletion Inhibits endogenous T cells that secrete regulatory cytokines Facilitates the expansion of transferred cells Tisagenlecleucel Porter D, et al. Sci Transl Med. 2015; 7(303):303ra139. Ramos et al. Cancer J. 2012;20(2): MFMER slide-14

15 Lymphodepleting chemotherapy Infuse tisagenlecleucel 2 to 14 days after completion of lymphodepleting therapy Fludarabine 30 mg/m 2 IV daily for 4 days; AND Cyclophosphamide 500 mg/m 2 IV daily for 2 days starting with the first dose of fludarabine Porter D, et al. Sci Transl Med. 2015; 7(303):303ra139. Ramos et al. Cancer J. 2012;20(2): MFMER slide-15

16 Patient case After JM s first course of treatment he achieved complete remission. It was determined that JM s ALL had cytogenetic abnormalities that increased his risk of relapse, so after achieving remission he also underwent an allogeneic HSCT. After 12 months in remission JM returns to his 1 year follow-up appointment. Unfortunately it is determined that JM s ALL has relapsed and he needs additional treatment MFMER slide-16

17 Patient case JM is started on tisagenlecleucel. After his infusion he develops a high fever, difficulty breathing, chills, severe nausea and hypotension. Which of the following is the most likely cause of this reaction? 1. Neurological toxicity 2. Febrile neutropenia 3. Cytokine release syndrome 4. Hypofibrinoginemia 2017 MFMER slide-17

18 CAR-T Toxicities Challice L Bonifant, published online. 20 April doi: /mto MFMER slide-18

19 Tisagenlecleucel REMS Enroll in the Risk Evaluation and Mitigation Strategy (REMS) program Created to mitigate the risk of cytokine release syndrome (CRS) and neurotoxicity Ensures that facilities and prescribers have appropriate training and access to management medications Risk Evaluation and Mitigation Strategy (REMS): Cytokine release syndrome and neurological toxicities. Novartis Pharmaceuticals Corporation MFMER slide-19

20 Treatment of CRS CRS severity Prodromal syndrome: low-grade fever, fatigue, anorexia Overt CRS (> 1 of the following) - High fever - Hypoxia - Mild hypotension Management Observe, exclude infection, administer antibiotics if neutropenic Administer antipyretics, oxygen, IV fluids and/or vasopressors as needed Kymriah [package insert]. Novartis Pharmaceuticals Corporation. New Hanover, NJ; MFMER slide-20

21 Treatment of CRS CRS severity Severe or Life-Threatening CRS (> 1 of the following): - Refractory hemodynamic instability - Worsening respiratory distress - Rapid clinical deterioration Resistant CRS No clinical improvement in 12 to 18 hours, or worsening despite management Management Administer vasopressors, oxygen, mechanical ventilation Administer tocilizumab Administer methylprednisolone Repeat tocilizumab Kymriah [package insert]. Novartis Pharmaceuticals Corporation. New Hanover, NJ; MFMER slide-21

22 Management of CRS in B2202 CRS management Systemic Anticytokine given Tocilizumab 1 dose 2 doses 3 doses Total n = 53; [n(%)] 26 (49) 26 (49) 16 (30) 7 (13) Siltuximab 5 (9) Corticosteroids 14 (26) Other 2 (4) FDA Briefing Document Oncologic Drugs Advisory Committee Meeting. BLA : Lee et al. Blood. 2014; 124(2): Sebba et al. Am J Health Syst Pharm. 2008; 65(15): MFMER slide-22

23 Cytokine release syndrome in the B2202 Trial CRS occurred in 79% of patients Grade 3 or 4 CRS occurred in 49% (33/68) of patients Median time to onset was 3 days Range 1 to 22 days Time to grade 3 or 4 onset Within 6 days Median time to resolution was 8 days Range 1 to 36 days FDA Briefing Document Oncologic Drugs Advisory Committee Meeting. BLA : MFMER slide-23

24 Cytokine release syndrome in the B2202 Trial (n=68) No correlation between tisagenlecleucel dose and CRS Morbidity Fever Renal impairment Respiratory ICU admission Coagulopathy Tumor burden Consequence 49 (72%) of subjects had fevers lasting for a mean of 8 days with a range of 1 to 36 days Seven subjects (10%) required dialysis for a mean of 11 days 10 subjects (15%) required ventilatory support for a mean of 8.5 days (range 4 to 19 days) 31 subjects (46%) were admitted to an ICU with a mean LOS of 11 days (range 1 to 34 days) Hypofibrinoginemia grade 3: 14 subjects; grade 4: 18 subjects. One death due to intracranial hemorrhage Trend toward a correlation between higher tumor burden and CRS FDA Briefing Document Oncologic Drugs Advisory Committee Meeting. BLA : MFMER slide-24

25 B2202 CRS-Related Adverse Events 80% 70% Adverse Event Frequency 60% 72% 50% 40% 30% 46% 47% 20% 10% 0% Fever 10% Renal impairment ICU admission Coagulopathy FDA Briefing Document Oncologic Drugs Advisory Committee Meeting. BLA : MFMER slide-25

26 Neurotoxicity in the B2202 trial Reported in 44% (n=30) subjects Neurotoxicity was generally related to CRS development In 6 patients neurotoxicity occurred after CRS resolution Supportive treatment Maintain airway Seizure prophylaxis Corticosteroids Study had 1 death due to respiratory failure FDA Briefing Document Oncologic Drugs Advisory Committee Meeting. BLA : MFMER slide-26

27 Prolonged Cytopenias Cytopenias can occur for several weeks following lymphodepleting chemotherapy and tisagenlecleucel infusion Myeloid growth factors are not recommended Prolonged cytopenias are associated with infection Grade 3 and 4 cytopenias: Cytopenia (n=52) Day 28 Day 56 Neutropenia 40% 17% Thrombocytopenia 27% 12% Kymriah [package insert]. Novartis Pharmaceuticals Corporation. New Hanover, NJ; MFMER slide-27

28 Serious Infections Infection prophylaxis prior to tisagenlecleucel administration should follow local guidelines Types of infections in B2202 Unknown source: 41% Viral: 26% Bacterial: 19% Fungal: 13% Infection Incidence (n=68) All grades 40 (59%) Grade 3 or 4 24 (35%) Fatal 2 (3%) Kymriah [package insert]. Novartis Pharmaceuticals Corporation. New Hanover, NJ; MFMER slide-28

29 Post-Infusion Deaths in B2202 trial ALL: 7 Infections: 2 Respiratory tract infection Systemic mycosis Encephalitis CSF positive for HHV6B Cerebral hemorrhage: 1 FDA Briefing Document Oncologic Drugs Advisory Committee Meeting. BLA : MFMER slide-29

30 Tisagenlecleucel Efficacy Results N=63 CR/CRi N=52, (83%) 95% confidence interval (71% to 91%) P < CR N=40 (63%) CRi N=12 (19%) CR or CRi with MRDnegative bone marrow Duration of remission 52 (83%) 95% confidence interval (71% to 91%) P < N=52 (not reached) CR: Complete response CRi: Complete response with incomplete blood count recovery Kymriah [package insert]. Novartis Pharmaceuticals Corporation. New Hanover, NJ; MFMER slide-30

31 Balancing Risk and Benefit Tisagenlecleucel benefit Adverse effects 2017 MFMER slide-31

32 Summary Tisagenlecleucel is a novel CAR-T therapy that uses a patient s own T cells to treat ALL The process of engineering, administering and monitoring tisagenlecleucel is complex and requires a well-coordinated team Despite clinical efficacy, tisagenlecleucel exhibits multiple serious and life-threatening toxicities 2017 MFMER slide-32

33 Questions & Discussion 2017 MFMER slide-33

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