Cancer Progress. The State of Play in Immuno-Oncology
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1 Cancer Progress The State of Play in Immuno-Oncology Axel Hoos, MD, PhD VP, Oncology R&D, Glaxo Smith Kline Co-Director, Cancer Immunotherapy Consortium
2 Key Drivers in Immuno-Oncology Science Methods Combinations Innovation & Deals Collaboration
3 Generations of Cancer Therapies 1 Chemotherapy, Surgery, Radiation 2 Targeted Therapies 3 Immunotherapy
4 Cancer Immunotherapy Progress Sipuleucel T Ipilimumab Rituximab IL-2 Coley s Toxins CTLA-4 cloning Monoclonal Abs
5 Progress on 2 Fronts: Science & Methods Science Immune biology New targets for immune intervention Influence of conventional therapies on immune system Opportunities for biomarker development Methods Development Paradigm Clinical Endpoints New response criteria Assay use for immune biomarkers Data reporting guidelines Regulatory guidance Collaboration in the field Hoos A, et al. Nat. Biotechnol. 2011
6 Immune Checkpoint Molecules: Targets for Intervention Pardoll D., Nat Rev Cancer 2012
7 Checkpoint Modulator Discovery & Development Timelines Pardoll D, et al. Nat. Immunol. 2012
8 A Methodological Framework for Immuno-Oncology Collaborators Immune Biomarkers 2012 Publication Guide MIATA 2005 Development Paradigm FDA Guidance Regulatory Exchange Assay Harmonization Immunotherapy Endpoints 2009 New Response Criteria Hoos et al., Nat. Biotechnol. 2011
9 Ipilimumab and the Immunotherapy Paradigm 1,2 Chemotherapy Paradigm Immunotherapy Paradigm Phase 3 CA (untreated) BMS Phase 2 MDX Phase 1/2 Phase 3 MDX (pretreated) Evolution of New Paradigm Clinical Endpoints 1. Hoos et al. Sem. Oncol Hoos et al. J. Natl. Cancer Inst. 2010
10 Oncology: Established Scientific Discipline Immuno-Oncology: Scientific Discipline in Evolution
11 Combinations
12 Dual Inhibition of the Same Target: HER2 in Breast Cancer Trastuzumab + Pertuzumab + Docetaxel PFS Interim OS Baselga J et al. N Engl J Med 2012;366:
13 Dual Inhibition of the MAPK Pathway: BRAF (Dabrafenib) + MEK (Trametinib) Randomized Phase 2: PFS Flaherty KT et al. N Engl J Med 2012;367:
14 N. Engl. J. Med. (2012), 366:
15 Addressing Resistance Host Immune System Pathways in Cancer Cells Within-Pathway Inhibition (Vertical) Across-Pathway Inhibition (Horizontal) Immunotherapy Combinations
16 Hypothesis: Synergism via TKI + Immunotherapy Example: BRAF-i + Checkpoint Modulator in Melanoma TKI: Dabrafenib (BRAF-i) IT: Ipilimumab (anti-ctla-4) Ipi + gp100 vs. gp100: Ipi vs. gp100: Ipi + gp100 vs. ipi: HR 0.68 ( ), p= HR 0.66 ( ), p= HR 1.04 ( ), p= Hauschild et al. Lancet 2012 Fast response Limited durability Hodi et al., New Engl. J. Med Delayed effect Long durability Combination: Expected Result: Caution: Immediate TKI effects bridge to long-term IT effects Larger proportion of long-term survivors Safety
17 Durability of Survival Effect Phase 1: Ipilimumab + PD-1 N=17 N=53 Censored 1 mg/kg nivolumab + 3mg/kg ipilimumab All Concurrent Died/Treated 2 / 17 9 / 53 Subjects at Risk 1 mg + 3 mg All concurrent Wolchok et al. ASCO #9012 Courtesy of Walter Urba, ASCO discussant
18 CAR Cellular Therapy: CD-19 receptor + co-stimulation Demonstrated Response for Selected Patients in B-Cell Malignancies U.Penn.: Clinical Response to CAR T-cell Therapy U.Penn.: Sustained in vivo expansion and persistence in blood and marrow of CART19 cells Kalos et al. Science Translat. Med Kalos et at, Science Translat. Med
19 Potential Added Survival Impact of Combinations Schlom J., J. Natl. Cancer Inst. 2012
20 Biomarkers
21
22 Prognostic and Biomarker Relevance of the Immune Contexture Fridman et al., Nature Reviews Cancer 2012, 12:
23 Immunogenic and Non-immunogenic Cell Death Kepp et al., Cancer Met. Review 2011
24 Immunogenic and Non-immunogenic Cell Death Tesniere et al., Oncogene 2009
25
26 High variability of results for the enzyme-linked immunosorbent spot (ELISPOT) immune response assay Hoos A et al. JNCI J Natl Cancer Inst 2010;102: The Author Published by Oxford University Press.
27 % of labs missing weak response Proficiency Panel Program: Reduced Variability Example: ELISPOT Assay (n= 36) Panel 1 outcome 14 (n= 29) Implementation of Harmonization Guidelines (Panel 2 outcome) 7 (n= 41) Further Implementation of Harmonization Guidelines (Panel 4 outcome) Van der Burg, Sci. Transl. Med. (2011), 3:44-48
28 Methods
29 CANCER IMMUNOTHERAPY CONSORTIUM A Methodological Framework for Immuno-Oncology Improved Clinical Endpoints Clinical Development Paradigm Reliable Immunological Methods New Response Criteria Immuno-Oncology Biomarkers Regulatory Interactions Publication Framework Regulatory Guidance Other Elements
30 Interactions between Immune System and Tumor Response Stability Progression Schreiber R., Science 2011
31 Immunotherapy Patterns of Response Wolchok JD, et al. Clin Cancer Res. 2009;15: Hoos A et al. JNCI J Natl Cancer Inst 2010;102:
32 Anti-CTLA-4 (Ipilimumab): Response Patterns Delayed Response O Regan, KN, et al. AJR 2011
33 Response Observations with anti-pd-1 Topalian S., N. Engl. J. Med. 2012
34 Regression of metastatic RCC following anti-pd-1 therapy, with immune-related response characteristics. Lipson E J et al. Clin Cancer Res 2013;19: by American Association for Cancer Research
35 Autologous DC + IFN α2b in Advanced Melanoma: Delayed Response Wilgenhof S. et al., Melanoma Res. 2011
36 Cancer Immunotherapy: Response Characteristics Characteristic Anti-CTLA-4 Anti-PD-1 Cancer Vaccines Biologic role Control of T-cell activation Modulation of T-cell activity in tissue; - Immune resistance - T-cell exhaustion Stimulation of antigenspecific immune responses Compartment Blood and lymph node Blood, lymph node and Tissue / Tumor Blood and lymph node RECIST/WHO Response Rate ~10% 18-50% <5% irrc Activity Patterns ~10% Increasing number of individual reports Individual reports Durability of Response Durable Durable N/A Survival Improved in melanoma Under investigation Not demonstrated
37 Trends in Immuno-Oncology
38 Evolution of the Field: Societies 30 Cancer Immunology Societies Source: Cancer Research Institute
39 Evolution of the Field: Journals 18 Cancer Immunology Journals Source: Cancer Research Institute
40 Evolution of the Field: CIC Membership 120 CIC Members Source: Cancer Research Institute
41 Origins of Innovation: New Drugs All New Drugs New Drugs Approved by US FDA Kneller R., Nat. Reviews Drug Discovery 2010
42 Origins of Innovation: New Drugs New vs. Old Scientific Concepts New Drugs Approved by US FDA Kneller R., Nat. Reviews Drug Discovery 2010
43 Origins of Innovation: New Drugs Regulatory Review Priority - s = standard (drug) p = priority (drug) b = priority (biologic) 252 New Drugs Approved by US FDA Kneller R., Nat. Reviews Drug Discovery 2010
44 Industry Deals on Immune Co-Stimulation Selected co-receptor drug discovery & development deals Company Partner Targets Potential Value Date BMS Medarex CTLA-4, PD-1 $2.4 billion a 7/28/2009 GlaxoSmithKline (GSK) UT MDACC OX40 $335 million 12/7/2012 GSK Amplimmune PD-1 $508 million 8/4/2010 MedImmune CRI, LICR CTLA-4, OX40, PDL1 MedImmune 4-Antibody, Recepta BioPharma a Acquisition deal AgonOx; Providence Cancer Center n/a 10/9/2012 OX40 n/a 10/31/2011 LICR n/a n/a 1/29/2013 Company Foundings: Jounce Pharmaceuticals CoStim Pharmaceuticals Third Rock Ventures MPM Capital Source: Nat. Biotechnol. March 2013
45 2014 is the year of Immuno-Oncology Icarus Consulting at JP Morgan
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