Hodgkin Lymphoma New Combo-Steps

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1 New Drugs In Hematology Hodgkin Lymphoma New Combo-Steps Anas Younes, M.D. Chief, Lymphoma Service Memorial Sloan-Kettering Cancer Center Monday, May 9, :55-3:10 p.m

2 Combinations with Immune Checkpoint Inhibitors Ledford, H: Nature, April 2016

3 Development of Anti-PD1/PDL1-Based Therapy Ibrutinib Revlimid Brentuximab Vedoton a-cd20 PD1/PDL1 mab HDACi Chemo therapy Urelumab (4-1BB) Ipililumab (CTAL4)

4 % Response rate Updated from Betlevi and Younes, Hematology Am Soc Hematol Educ Program Smith, K et al : Hodgkin Lymphoma, Hoffan Textbook of Hematology 2015 (In Press) Single agent activity of novel agents in relapsed chl High response rates - Potentially combinable at full doses 75 CR PR

5 Hodgkin Lymphoma : Future Directions Strategy A Strategy B PD1/PDL1 antibodies Chemo therapy PI3Ki mtori Chemo therapy Brentuximab vedotin PI3Ki mtori Brentuximab Vedotin + PD1/PDL1 antibody HDACi HDACi

6 Response adapted salvage therapy for transplant eligible HL 27% 45 patients Brentuximab Vedotin 1.2mg/kg Qwk x 3 followed by 1 wk rest Qwk x 3 followed by 1 wk rest R e s t a g e PET- 73% PET+ Stem cell collection => BEAM ASCT Augmented ICE Overall 76% achieved PET-/CR and proceeded to ASCT 69% PET- Stem cell collection => BEAM ASCT Alison Moskowitz et al, Lancet Oncology 2015

7 Tumour reduction after brentuximab vedotin Data shows PET status according to the Deauville scores of 1 5 Alison J Moskowitz, et al The Lancet Oncology,, 2015,

8 Nivolumab + Brentuximab Salavage Therapy for HL Brentuximab Vedotin 1.8mg/kg Nivolumab 240 mg Q 3wks x 4 R e s t a g e PR/CR < PR Stem cell collection => BEAM ASCT Chemo salvage Stem cell collection => BEAM ASCT

9 Development of Anti-PD1/PDL1-Based Therapy Ibrutinib Revlimid Brentuximab Vedoton a-cd20 PD1/PDL1 mab HDACi Chemo therapy Urelumab (4-1BB) Ipililumab (CTAL4)

10 Hodgkin and Reed Sternberg (HRS) Cells EBV Infection 9p24.1 Gene amplification CIITA-BX Gene fusion B2MG mutations JAK2 PDL1 MHC-II MHC-I PD1/PDL1 Antibodies JAK2i CD30 PD1 T cells HDACi Brentuximab Vedotin Chemotherapy

11 DAC Inhibitors: Regulation of Cell Survival and Immunity DACs Epigenetic effects on gene expression Increased p21 Decreased STAT6 Decreased Bcl-xL Caspase activation DAC inhibitor Inhibition of STAT6-mediated T H 2 cytokine/chemokine secretion/tarc Angiogenesis Cell-cycle arrest and apoptosis Favorable anti-tumor immune response Tumor response

12 DAC Inhibitors in HL: Regulation of Cell Survival and Immunity Before therapy After Aza After MGCD0103 CD8+ CD4+ PD-1

13 Panobinostat in Patients with Relapsed/Refractory HL 40 mg (fixed dose) orally, 3 times/week Younes A, et al. Blood. 2009;114: Abstract 923. Week Restage: If no PD Give Panobinostat until PD or tox

14 Best % Change in SPD From Baseline (index lesions only) Panobinostat Phase II Study in Relapsed HL % of patients with tumor reduction Active 75 Discontinued PD patients - SD (0%) PR 6 patients - off AE prior to Eval 1 1 patient - withdrew consent prior to Eval 1 1 patient - pending Eval 1 measurements patients with SPD < 50% had new lesions at Eval 1 Younes A,,Soreda A,, et al. JCO 2012

15 Panobinostat Downregulates PD-1 on T cells of Patients with Relapsed HL in Vivo Patient 1 Patient 2 CD8+ CD4+ CD8+ CD4+ Pretreatment Day 8 Day 15 PD1 Oki Y and Younes A - Blood Cancer J Aug; 4(8): e236.

16 HDACi Upregulate OX40L on HRS Cells Inhibition of T-reg function Buglio D, et al BLOOD 2011

17 Phase I/II Study of Entinostat (HDACi) + Pembrolizumab (anti-pd1) Entinostat Pembro Week

18 Development of Anti-PD1/PDL1-Based Therapy Ibrutinib Revlimid Brentuximab Vedoton a-cd20 PD1/PDL1 mab HDACi Chemo therapy Urelumab (4-1BB) Ipililumab (CTAL4)

19 Emerging Role for Chemo-FreeTherapy Newly diagnosed follicular lymphoma* 100% 75% 50% CR PR 25% 0% R + Lenalidomide R + Bendamustine R + CHOP R+ Ibrutinib R+ Len + Ibrutinib

20 Development of Anti-PD1/PDL1-Based Therapy Ibrutinib Revlimid Brentuximab Vedoton a-cd20 PD1/PDL1 mab PI3Ki/ mtori Chemo therapy Urelumab (4-1BB) Ipililumab (CTAL4)

21 Rationale for combining Ibrutinib with PD1/PDL1 antibodies T cell PD1 ITK IBRUTINIB TCR MHC I/II PD1 PD-L1 PD-L2 BTK BCR Malignant B Cell

22 Ibrutinib in combination with anti PD-L1 induces an antitumor immune response A20 mouse B cell lymphoma model 2015 by National Academy of Sciences Idit Sagiv-Barfi et al. PNAS 2015;112:E966-E972

23 The combination of ibrutinib with anti PD-L1 reduces tumor burden in 4T1 (Mouse Tripple Negative Breast Carcinoma) tumor-bearing mice by National Academy of Sciences Idit Sagiv-Barfi et al. PNAS 2015;112:E966-E972

24 PCI32765-LYM-1002: Study Design Nivolumab + Ibrutinib in relapsed B-cell malignancies Part A n=18 (Dose Optimization) Part B (n=30 in each cohort) (Expansion Cohort: Two-stage design) B 1: I: 420 mg/qd PO + N: 3 mg/kg/q14d A-1 I: 420 mg, po, qd N: 3mg/kg, i.v., q14d A-2 I: 560 mg, p.o., qd N: 3 mg/kg, i.v., q14d B1: CLL (del 17p or del 11q) B 2 and B 3: I: 560 mg/qd PO + N: 3 mg/kg/q14d B2: Follicular Lymphoma B3: DLBCL

25 Development of Anti-PD1/PDL1-Based Therapy Ibrutinib Revlimid Brentuximab Vedoton a-cd20 PD1/PDL1 mab HDACi Chemo therapy Urelumab (4-1BB) Ipililumab (CTAL4)

26 Development of Anti-PD1/PDL1-Based Therapy Frontline Regimens PD1/PDL1 antibody + DLBCL FL HL G-CHOP G-Benda G-CHOP ABVD

27 Phase I/II ABVD + Nivolumab in Advances Stage HL PET2 ABVD ABVD ABVD ABVD ABVD ABVD Nivo Nivo Nivo Nivo Nivo Nivo Nivo Nivo Nivo Nivo Nivo Nivo Nivo Nivo Nivo Nivo Nivo Nivo Nivo Nivo Nivo Nivo Nivo Nivo - ABVD ABVD ABVD ABVD ABVD ABVD PET2 + ABVD ABVD ABVD ABVD Nivo Nivo Nivo Nivo Nivo Nivo

28 Evaluating ctdna in Curable Lymphomas (HL and DLBCL) ctdna DLBCL RCHOP + Nivo HL ABVD + Nivo Months

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