Relapsed/Refractory Hodgkin Lymphoma

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1 Relapsed/Refractory Hodgkin Lymphoma Robert Chen, MD Associate Professor of Medicine Co-Leader of Lymphoma Disease Team Associate Director of Toni Stephenson Lymphoma Center City of Hope National Medical Center

2 Hodgkin Lymphoma ~9000 new cases in the US per year ~1200 deaths annually in the US per year 10% of all lymphomas and 0.6% of all cancers Bimodal distribution (20, 65) HIV, prior solid organ or hematopoietic cell transplantation, and autoimmune diseases are at higher risk Diehl V et al. In: DeVita VT Jr et al, eds. Cancer: Principles and Practice of Oncology. Vol 2. 8th ed. Philadelphia, PA: Lippincott Williams and Wilkins; 2008: American Cancer Society. Cancer Facts & Figures Atlanta, GA: American Cancer Society; 2011.

3 Pathology Classical Nodular sclerosis Mixed cellularity Lymphocyte rich Lymphocyte depleted CD 15 and CD 30 + Lack of pan B and pan T antigens (CD 19, 20, 79a, 3, and 7) Reed-Sternberg (RS) cells in a reactive infiltrate (0.1 to 10%) Pileri SA et al. J Clin Pathol. 2002;55(3): Stein H et al. In: Swerdlow SH et al, eds. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. 4th ed. Lyon, France: IARC; 2008:

4 Relapse post AHCT Approximately 50% of patients who undergo AHCT relapse Chemotherapy options post AHCT induce substantial morbidity Overall Survival in Patients Who Relapse Post-AHCT Median = 2.4 years Post AHCT therapies largely palliative No approved treatment Pronounced unmet need Horning et al, 10th International Conference on Malignant Lymphoma, Lugano, Switzerland, 2008

5 Results of a Pivotal Phase 2 Study of Brentuximab Vedotin (SGN-35) in Patients with Relapsed or Refractory Hodgkin Lymphoma R Chen, AK Gopal, SE Smith, SM Ansell, JD Rosenblatt, R Klasa, JM Connors, A Engert, EK Larsen, DA Kennedy, EL Sievers, A Younes American Society of Hematology 52nd Annual Meeting December 4 7, 2010

6 Brentuximab Vedotin

7 Phase II Pivotal, Multicenter, Relapsed/Refractory HL Eligibility Relapsed or refractory CD30+ HL Age 12 years Measurable disease 1.5 cm ECOG 0 1 Prior ASCT Treatment (N=102) Brentuximab vedotin 1.8 mg/kg IV every 21 days Administered outpatient over 30 min Max 16 cycles for SD or better Restage at Cycles 2, 4, 7, 10, 13, 16 Follow-up Every 12 weeks Revised Response Criteria for Malignant Lymphoma (Cheson, 2007)

8 Response Results N=102 IRF Investigator Overall response rate (95% CI) 75% (65, 83) 72% (62, 80) Complete remission 34% 33% Partial remission 40% 38% Stable disease 22% 27% Progressive disease 3% 0% Not evaluable 1% 1%

9 % Patients Free of PD or Death 2º Endpoints:PFS PFS by Best Response Category, per IRF CR n=35 PR n=41 SD n=22 PD n=3 Time (Weeks)

10 Treatment-Emergent Adverse Events AE > 20% All Grades AE > 5% Grade 3 Grade 4 Peripheral sensory neuropathy 47% Fatigue 46% Nausea 42% Upper respiratory tract infection 37% Diarrhea 36% Pyrexia 29% Neutropenia 22% Vomiting 22% Cough 21% Neutropenia 14% 6% Peripheral sensory neuropathy 8% Thrombocytopenia 6% 2% Anemia 5% 1%

11 Peripheral Neuropathy In the Hodgkin lymphoma and salcl clinical trials, 54% of patients experienced any grade of PN PN at last evaluation Complete resolution 49% 11

12 Conclusions Pivotal trial of brentuximab vedotin in 102 Hodgkin lymphoma patients who recurred post ASCT: ORR 75%; median duration of 29 weeks by IRF CR 34%; median duration not reached 94% of patients achieved tumor reduction Manageable adverse events; peripheral neuropathy largely reversible Presented ASH 2010 Received accelerated FDA approval in Aug 2011 Published JCO 2012

13 5 Year Updates All patients 5 year OS 41%, PFS 22% 15 pts remain in remission (6 had Allo-HCT and 9 no further therapy) 9/102 (9%) Patients in CR (33%) 5 year OS 64% and PFS 52% Median PFS and OS not reached yet 13 patients remain in remission (4 had Allo-HCT and 9 no further therapy) Chen et al, ASH 2015, Blood 7/2016, Epub

14 5 Year Updated Results Chen et al, ASH 2015, Blood 7/2016, Epub

15 PFS According to Best ORR

16 Patients in CR

17 Allo-HCT vs. no Allo

18 Retreatment Data Phase II multicenter Trial Achieved CR or PR with brentuximab vedotin on prior study 1.2 or 1.8 mg/kg IV every 21 days Response per Cheson 2007 criteria Patients Characteristics N 24 Age, years (median) 34 (16-72) HL 16 ALCL 8 Median duration of response with prior BV 9.6 (0+, 14.2+) months Bartlet N et al. J Hem Oncol 2014

19 CD 30 in HL pts Pre-BV H & E CD30 H &E CD 30 H & E CD30 Post- BV Pre-BV Post-BV Chen R et al. EHA 2013

20 Efficacy in Retreatment N = 24 Response (%) 95% CI Duration of response, in months Median (95% CI) Range ORR , (2.6, NE) 0 to 28+ Best Clinical Response Response HL (15) ALCL (8) Total (23) CR 3 (20%) 6 (75%) 9 (39%) PR 6 (40%) 1 (13%) 7 (30%) SD 2 (13%) 0 2 (9%) Bartlett N et al. J Hematol Oncol 2014

21

22 Most Common (> 15%) Adverse Events in Retreatment

23 Allo-HCT Approximately 50% of patients with Hodgkin lymphoma relapse after AHCT Median OS in post-transplant relapse is only 2.4 years (Horning et al. 2008) Myeloablative (TRM ~40%) vs. RIC (TRM~15%) A minority of patients are eligible High relapse rate: 5-year PFS 20% Lack of disease control prior to allo-hct

24 Chen et al. Ann of Hematology 2010 Historical Data: EBMT Group Conditioning Regimen BEAM Flu/TBI Flu/Mel Bu/Mel/Cy Cell Source Follow-up NRM OS PFS PB BM 75 months 3 yr, 24% 5 yr, 28% 5 yr, 18% EBMT 2012 Flu/Mel PB BM N/A 1 yr, 15% N/A 1 yr 48% 4 yr 24% Dana Farber Bu/Flu PB BM 26 months 3 yr, 23% 3 yr, 56% 3 yr, 22% MDACC Flu/Mel PB BM 24 months 2 yr, 15% 2 yr, 64% 2 yr, 32% COH Flu/Mel PB UCD 26 months 2 yr, 13% 2 yr, 60% 2 yr, 27% Fred Hutchinson TBI Flu/TBI PB 25 months MRD: 2 yr, 21% MUD: 2 yr, 8% MRD: 2 yr, 53% MUD: 2 yr, 58% MRD: 2yr, 23% MUD: 2 yr, 29%

25 Haploidentical HCT Group Conditioning GVHD NRM OS PFS Brazil Flu/Cy/TBI CsA or Tac MMF PT-Cy Italian Flu/Cy/TBI + Thiotepa CsA or Tac MMF PT-Cy French Flu/Cy/TBI CsA or Tac MMF PT-Cy Spanish Flu/Cy/Bu CsA or Tac MMF PT-Cy 2 yr, 26% 2 yr, 66% 2 yr, 54% 2 yr, 4% 4 yr, 77% 4 yr, 63% 3 yr, 9% 3 yr, 75% 3 yr, 66% 1 yr, 21% 2 yr, 48% 2 yr, 58%

26 Brentuximab Vedotin (SGN-35) Enables Successful Reduced Intensity Allogeneic Hematopoietic Cell Transplantation in Relapsed/Refractory Hodgkin Lymphoma Robert Chen, MD, Stephen J. Forman, MD, Joycelynne Palmer, PhD, Ni-Chun Tsai, MS, Leslie Popplewell, MD, Maria Delioukina, MD, Alejandra Torres, MS, Bernie Pulone, RN, Eileen Smith, MD, Chatchada Karanes, MD, Auayporn Nademanee, MD, Len Farol, MD, Samer Khaled, MD, Paul O Donnell, MD, PhD, David Maloney, MD, PhD, Schickwann Tsai, MD, Laurie E. Grove, PA-C, Ajay K. Gopal MD. City of Hope National Medical Center, SCCA/Fred Hutchinson Cancer Research Center, and Seattle Genetics, Inc. Lymphoma SPORE, COH Comprehensive Cancer Center Grant RC is a Tim Nesvig Lymphoma Fellow and K12 recipient AG is a Clinical Research Scholar of the Leukemia and Lymphoma Society

27 Baseline Characteristics Characteristics N (%) or median (range) Median age 30.5 (range: 23-55) Median number of prior regimens (excluding conditioning) Prior auto-hct 17/18 Previous XRT 10/ (range: 3-8) Best response to brentuximab vedotin Median number of cycles of brentuximab vedotin CR (39%), PR (44%), SD (11%), PD (6%) 7 (range: 2-16)

28 Probability or Cumulative Incidence 1 Year Results CR 100% 1-year OS: 100% 1-year PFS: 92.3% (CI: 61.3, 98.7) 1-year Relapse Rate: 7.7% (CI: 1.3, 38.7) 1-year NRM: 0% Overall Survival Progression Free Survival Non-Relapse Mortality Time (Months) from Transplant Chen et al. Blood 2012

29 Survival Probability 2 Year Results: With a median follow-up 25.6 months: 2 year OS: 79.3% (CI: 56.0, 91.1) 2 year PFS: 59.3% (CI: 43.9, 71.7) 2 year NRM: 12.5% (CI: 1.8, 33.9) Overall Survival Progression Free Survival Time (Months) from Transplant Chen et al. 12 th International Congress on Malignant Lymphoma, Lugano 2013

30 HL treatment landscape Prior to 2011 ABVD ICE + AHCT Novel Therapy Allo-HCT Newly diagnosed Post st relapsed/ refractory Relapse post AHCT BV BV + Allo-HCT Novel Therapy

31 Induction Failure 20%-30% of Hodgkin lymphoma (HL) patients are refractory/relapsed to induction regimen of ABVD Standard combination chemotherapy regimens followed by AHCT can cure ~50% of patients. CR status at AHCT is predictive of outcome. (2 year PFS 75% vs. 31%) Josting A et al. Ann Oncol Moskowitz CH et al. Blood Santoro A et al. Haematologica 2007 Bartlett NL et al. Ann Oncol 2007 Kuruvilla J et al. Cancer Moskowitz A et al. Blood 2010 Moskowitz CH et al. Blood. 2012

32 Standard Salvage Chemotherapy Salvage regimen N RR (%) CR (%) (no PET) ICE 65 88% 26% DHAP % 21% GVD 91 70% 19% GDP 23 69% 17% CR (%) PET ICE/augICE 97 60% IGEV 91 81% 53.8% Moskowitz CH et al. Blood Moskowitz CH, et al. Blood2012; 119(7): BaetzT, et al. Annals of Oncology2003; 14(12): JostingA, et al. Annals of Oncology2002; 13(10): Santoro A, et al. Haematologica2007; 92(1): Bartlett NL, et al. Annals of Oncology2007; 18(6):

33 Investigator Initiated Study COH and Cornell CR BV x 2 cycles CT or PET Scan CR PR SD PD BV x 2 cycles Salvage chemo CT or PET Scan PR SD PD Stem cell mobilization ASCT Salvage chemo BV given at 1.8 mg/kg IV outpatient every 3 weeks for 4 cycles max No premedication with first cycle

34 Baseline Patient Characteristics Characteristics N (%) or Median (Range) Age 34 (11-67) Institution City of Hope Weill Cornell Stage at Diagnosis I-II III-IV 31 (84%) 6 (16%) 19 (51%) 18 (49%) B symptoms 23 (62%) Bulky Disease (> 5 cm) 32 (86%) Induction Chemotherapy ABVD ABVD/BEACOPP ABVE-PC Prior XRT 9 (24%) Best Response to Induction Primary Refractory Relapsed (within 7 months) 24 (65%) 13 (35%)

35 Response Rates Best response to BV, N=37 Response to combination chemotherapy (ICE/DICE/IGEV/GND) post-bv, N=18 ORR 25/37 (68%) 16/18 (89%) CR 13/37 (35%) 10/18 (56%) PR 12/37 (32%) 6/18 (33%) SD 10/37 (27%) 1/18 (6%) PD 2/37 (5%) 1/18 (6%) Univariate analysis: no differences in terms of age, sex, disease stage, response to induction, bulky disease, or B symptoms.

36 Cumulative Incidence / Survival Probability PFS results post ASCT Median f/u 27.3 Months OS 93.6% (76.9, 98.4) Overall Survival Progression Free Survival Non-Relapse Mortality PFS 71.9% (52.9, 84.3) NRM D % (0.5, 21.5) Time (Months) from Transplant Chen et al, ASH 2015, Herrera et al, Cologne 2016

37 Survival Probability CR vs. Non-CR Disease Status at HCT 0.1 CR (n=23) p-value = > CR (n=9) Time (months) from Date of Transplant CR -78.3% (55.4, 90.3) Non CR -55.6% (20.4, 80.5)

38 Survival Probability BV vs. BV + Chemo BV -80.0% (50.0, 93.1) BV + Chemo -68.8% (40.5, 85.6) nd Salvage Therapy 0.1 BV only (n=15) p-value = BV + Chemo (n=16) Time (months) from Date of Transplant

39 Memorial Sloan Kettering Similar Study Weekly BV 1.2 mg/kg, 3 weeks on, 1 week off CR 34% (12/14 CR seen at 8 weeks) Moskowitz A et al. Lancet Oncology 2015

40 Conclusion ORR 68%, CR 36% Toxicity profile well tolerated Patients required no growth factor support, PRBC, or platelet transfusions 86% went to AHCT successfully, 47% went to AHCT without additional salvage chemotherapy Stem cell mobilization not affected For patients with relapsed/refractory HL after induction chemotherapy, BV can be considered as first line salvage therapy

41 BV based regimens Salvage regimen N RR (%) CR (%) PET BV + ICE (sequential) 37 86% 65% BV + augice (sequential) 45 82% 74% BV + Bendamustine 55 93% 74% BV + ESHAP 66 94% 70% BV + ICE (concurrent) 16 94% 69% BV + Nivo 42 90% 62%

42 The PD-1 and PD-L1/L2 Pathway PD-1 is an immune checkpoint receptor Binding of PD-1 to PD-L1 or PD-L2 leads to downregulation of T-cell function This mechanism is usurped by many tumors PD-1 blockade through mab therapy can restore effective anti-tumor immunity Topalian et al. N Engl J Med Garon et al. N Engl J Med Robert et al. Lancet

43 CheckMate 205: Study Design, Cohort B Inclusion criteria Prior ASCT Brentuximab vedotin Relapsed/refractory chl Single-arm Nivolumab 3 mg/kg (every 2 weeks) Treatment until disease progression or unacceptable toxicity Minimum follow-up: 6 months Primary endpoint ORR assessed by IRRC a Secondary and other endpoints IRRC-assessed DOR for complete and partial remission Investigator-assessed ORR and DOR IRRC-assessed PFS OS Safety QoL Biomarkers 43 a Per the 2007 International Working Group (IWG) criteria. IRRC = independent radiologic review committee

44 CheckMate 205B Baseline Characteristics Characteristic Age, median (range) <65 years Data shown as n (%) unless indicated otherwise a Excluding high-dose preparative regimen prior to ASCT Patients (N = 80) 37 (18 72) 77 (96) Sex Male 51 (64) ECOG performance status 0 1 Previous lines of therapy, a median (range) 5 lines of therapy 42 (53) 38 (48) 4 (3 15) 39 (49) Previous radiation therapy 59 (74) Previous ASCT (100) 74 (93) 6 (8) Prior brentuximab vedotin therapy after ASCT 80 (100) No response to prior brentuximab vedotin 43 (54)

45 CheckMate 205B Nivolumab Objective response rate, n (%) 95% CI Best overall response, n (%) Complete remission Partial remission Stable disease Progressive disease Unable to determine IRRC (N = 80) 53 (66) (9) 46 (58) 18 (23) 6 (8) 3 (4) Investigator (N = 80) 58 (73) (28) 36 (45) 18 (23) 3 (4) 1 (1) Patients with no prior response to most recent brentuximab vedotin treatment IRRC (N = 43) Investigator (N = 43) Objective response rate, n (%) 31 (72) 35 (81) Younes A et al. EHA 2016

46 Probability of event Progression-Free and Overall Survival % OS (3/80 events) % PFS (24/80 events) Months Median follow-up (range) 8.9 months ( ) Median PFS (95% CI) 10.0 months (8.41 NA) PFS rate at 6 months (95% CI) 76.9% (65% 85%) Median OS Not reached PFS per IRRC assessment OS rate at 6 months (95% CI) 98.7% (91% 100%)

47 CheckMate 205B Adverse Events Total patients with an event (%) Any grade Grade 3 4 Any AE 79 (99) 32 (40) Treatment-related AE 72 (90) 20 (25) Treatment-related AE leading to discontinuation: Autoimmune hepatitis Increased ALT and AST Multi-organ failure* 3 (4) (3) Treatment-related serious AE 5 (6) 0 Treatment-related death 0 0 Serious AEs (SAEs) included pyrexia, tumor progression, arrhythmia, infusion reaction, septic meningitis, and pneumonia ( 4% each)

48 KEYNOTE-087: Study Design Cohort 1 (N = 60) R/R chl who progressed after ASCT and subsequent BV therapy Cohort 2 (N = 60) R/R chl who failed salvage chemotherapy, ineligible for ASCT and failed BV therapy Pembrolizumab 200 mg Q3W Response assessed according to Revised Response Criteria for Malignant Lymphomas (Cheson 2007) Survival Follow-Up Cohort 3 (N = 60) R/R chl who failed ASCT and not treated with BV post transplant CT scans repeated Q12W PET repeated at W12, W24, to confirm CR or PD, and as clinically indicated Primary end point: ORR (central review) Secondary end points: ORR (investigator review), PFS, OS Prespecified interim analysis, based on investigator-assessed response, performed after 30 patients in all 3 cohorts reached first response assessment

49 Baseline Characteristics Characteristic (N = 30 in each cohort) Cohort 1 Progressed after ASCT and subsequent BV therapy n (%) Cohort 2 Failed salvage chemotherapy, ineligible for ASCT and failed BV therapy n (%) Cohort 3 Failed ASCT and not treated with BV post transplant n (%) Age, median (range) 36 (19-64) 33 (20-71) 30 (18-67) Age > (20) 1 (3) Lines of systemic therapy, median (range) 5 (3-12) 4 (1-10) 3 (2-10) Primary refractory 7 (23) 15 (50) 15 (50) Prior radiation therapy 14 (47) 8 (27) 13 (43) Bulky lymphadenopathy 2 (7) 3 (10) 1 (3) Baseline B symptoms 7 (23) 6 (20) 7 (23) Bone marrow involvement 0 3 (10) 1 (3) Prior brentuximab failure 30 (100) 30 (100) 12 (40) 49

50 ORR by Cohort (BICR) Cohort 1 Progressed after ASCT and subsequent BV therapy N=69 Cohort 2 Failed salvage chemotherapy, ineligible for ASCT and failed BV therapy N = 81 Cohort 3 Failed ASCT and not treated with BV post transplant N = 60 n (%) 95% CI n (%) 95% CI n (%) 95% CI ORR 51 (73.9) (64.2) (70.0) Complete remission* 15 (21.7) (24.7) (20.0) Partial remission 36 (52.2) (39.5) (50.0) Stable disease 11 (15.9) (12.3) (16.7) Progressive disease 5 (7.2) (21.0) (13.3) Unable to determine 2 (2.9) (2.5) (0)

51 Cumulative Event Rate (%) Treatment Exposure and Response Duration: Cohort 1 Progressed after ASCT and subsequent BV therapy + Treatment Ongoing Complete Response Partial Response Progressive Disease Last Dose Months n at risk Months Median number of treatment cycles: 13 (range, 1-21) Length of the bar signifies time to last scan Data cutoff: September 25, 2016 Median (range) time to response 2.7 months ( ) Median (range) duration of response 8.7 ( ) Response duration 6 months: 82.2%

52 Conclusion BV 5 year OS 54%, PFS 22% Has long follow up PD1 inhibitors Pembrolizumab, PFS was 69% at 4 month and 46% at 13 months Nivolumab PFS was 86% at 4 month Follow up short RIC Allo-HCT Has the longest track record GVHD, VOD, TRM

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