ASCO 2016 * Investor Meeting June 4, *American Society of Clinical Oncology, June 3-7, 2016 ASCO 2016 NOT FOR PRODUCT PROMOTIONAL USE
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1 ASCO 2016 * Investor Meeting June 4, 2016 *American Society of Clinical Oncology, June 3-7,
2 Forward-Looking Information During this meeting, we will make statements about the Company s future plans and prospects that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of Actual results may differ materially from those indicated as a result of various important factors, including those discussed in the company s most recent annual report on Form 10-K and reports on Form 10-Q and Form 8-K. These documents are available from the SEC, the Bristol-Myers Squibb website or from Bristol-Myers Squibb Investor Relations. In addition, any forward-looking statements represent our estimates only as of today and should not be relied upon as representing our estimates as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our estimates change. 2
3 Today s Agenda Introduction Immuno-Oncology Strategy Key Data at ASCO Next Wave of Innovation Conclude / Q&A 3
4 BMS Immuno-Oncology: Transforming Cancer Care Giovanni Caforio Chief Executive Officer 4
5 Our Strategic Foundation Best of BIOTECH Best of PHARMA Diversified Specialty BioPharma INNOVATE INTEGRATE IMPROVE People helping patients in their fight against serious disease 5
6 BMS Immuno-Oncology: Transforming Cancer Care 6
7 Immuno-Oncology Strategic Priorities Maintain Leadership in Lung Cancer Enhance Survival with Opdivo+Yervoy Regimen Expand I-O Use into Earlier Settings Accelerate Next Wave Therapeutics 7
8 Immuno-Oncology Strategy Francis Cuss Chief Scientific Officer 8
9 Leading In Immuno-Oncology Approvals Years 13 Positive registrational trials >8 Opdivo Avastin Taxotere 9 <2 Approvals Years 0 Global Approvals for Opdivo 10 5 New England 9 Journal of Medicine Publications FDA Approvals in I-O Phase III trials stopped early due to survival benefit 14 Tumors with ongoing and planned registrational trials 6 Breakthrough Therapy Designations Note: All milestones since
10 Immuno-Oncology Strategic Priorities Maintain Leadership in Lung Cancer Enhance Survival with Opdivo+Yervoy Regimen Expand I-O Use into Earlier Settings Accelerate Next Wave Therapeutics 10
11 Scientific Rationale for Combining Opdivo and Yervoy Complementary MoAs that work together to maximize anti-tumor immunologic responses YERVOY blocks CTLA-4 to: 1) Help stimulate T-cell activation and proliferation 2) Deplete T-reg cells and reverse immunesuppression YERVOY YERVOY CTLA-4 Receptor T cell PD-L1 PD-L2 PD-1 Receptor OPDIVO OPDIVO blocks PD-1 to: 1) Enable T-cells to recognize and attack tumor cells 2) Prevent activationinduced T-cell death T-reg cell Tumor Memory T cell Some activated T cells become memory cells that can support subsequent immune responses by recognizing the tumor antigen 11
12 Broad Development of + Currently Approved Ongoing Trials * Study Melanoma -069, -067 Opdivo + Yervoy Data at Study Melanoma -067 NSCLC -012 SCLC -032 GBM -143 CRC-MSI -142 Gastric -032 Study Melanoma -004, -218, -511, -401,-204 NSCLC -012, -227, -568 SCLC -032, -451 RCC -016, -214 GBM -143 CRC-MSI -142 Gastric -032 Head & Neck -651 HCC -040 Pancreatic, TNB, Bladder, Ovarian -032 Hematological -039 Virus Associated Tumors -358 *7 potentially registrational 12
13 Expand I-O Use into Earlier Settings Neo Adjuvant Adjuvant Locally Advanced Melanoma RCC Melanoma NSCLC RCC Bladder Gastric Esophageal NSCLC Head & Neck 13
14 Accelerate Next Wave Therapeutics Improve outcomes through combinations Patients who do not respond to Opdivo +/- Yervoy Patients who progress after treatment with Opdivo +/- Yervoy Additional tumors, including where signals are not sufficient 14
15 : Key Takeaways Unprecedented first line lung data with Opdivo and Yervoy in PD-L1 expressers Broadening the Potential Benefit of Opdivo + Yervoy Redefining the Potential for Long-Term Survival Promise of I-O in additional tumors 15
16 Key Data at Fouad Namouni Head of Medical 16
17 Review of Select Key Data NSCLC SCLC Bladder Colorectal CheckMate-017 / -057: Phase 3 Opdivo in 2 nd line NSCLC CheckMate-012: Phase 1 Opdivo plus Yervoy combination in 1 st line NSCLC CheckMate-032: Phase 1 Opdivo plus Yervoy combination or Opdivo as monotherapy in 2 nd line SCLC CheckMate-032: Phase 1 Opdivo in 2 nd line Urothelial (Bladder) CheckMate-142: Phase 2 Opdivo plus Yervoy combination or Opdivo as monotherapy in 2 nd line MSI-H mcrc 17
18 Strategy Addresses Broad Lung Population Opdivo as Backbone Translational Research APPROACHES + Yervoy + Novel MOAs + Chemo + Targeted Therapies Collaborations and BD 18
19 Lung Cancer: Broad Registrational Program 2L+ NSCLC Checkmate-017 Opdivo monotherapy, Squamous Checkmate-057 Opdivo monotherapy, Non-Squamous Approved in US, Europe, and Japan 1L NSCLC Checkmate-026 Opdivo Monotherapy, PD-L1+ Checkmate-227 PD-L1+: Opdivo monotherapy and Opdivo+Yervoy PD-L1-: Opdivo+Yervoy and Opdivo+chemo Enrollment Complete Currently Recruiting SCLC Checkmate-331 Opdivo monotherapy, 2L limited or extensive disease Checkmate-451 Opdivo monotherapy and Opdivo+Yervoy followed by Opdivo maintenance, 1L extensive disease Currently Recruiting Currently Recruiting Monotherapy Combination 19
20 Non-Small Cell Lung Cancer (NSCLC) 20
21 CheckMate -017 and -057: Sustained Benefit at 2 Years NSCLC CheckMate 017 (SQ NSCLC) CheckMate 057 (NSQ NSCLC) OS (%) No. of patients at risk: Opdivo Docetaxel Time (Months) y OS rate = 24% y OS rate = 42% y OS rate = 8% Opdivo Docetaxel 2-y OS rate = 23% OS (%) No. of patients at risk: Opdivo Docetaxel Time (Months) y OS rate = 39% y OS rate = 51% y OS rate = 16% Opdivo Docetaxel 2-y OS rate = 29% Borghaei et al 21
22 Higher response rates, nearly double that of Opdivo monotherapy Enhanced efficacy with increasing levels of PD-L1 expression Deep and durable responses have the potential to improve long term survival Combination regimen remains well tolerated, with low discontinuation rates due to adverse events NSCLC CM-012 CheckMate-012: Longer Term Data Increases Confidence in First Line NSCLC Strategy 22
23 CheckMate-012: Evaluation of Multiple Regimens in First Line NSCLC NSCLC CM-012 Stage IIIB/IV NSCLC; no prior chemotherapy for advanced disease Opdivo monotherapy Opdivo + Yervoy Opdivo + PT-DC Opdivo + Bevacizumab Opdivo + Erlotinib Broadest data set with multiple regimens in first line NSCLC Only I-O/I-O combination data presented in first line setting 23
24 Opdivo + Yervoy in First-line NSCLC: Baseline Patient Characteristics Opd 3 Q2W + Yer 1 Q12W (n = 38) Opd 3 Q2W + Yer 1 Q6W (n = 39) Opdivo Mono 3 Q2W (n = 52) Median age, years (range) 68 (50 91) 62 (47 87) 67 (43-85) Male, % Non-squamous histology, % Disease stage, % Stage IIIB Stage IV Smoking status, % Never Former/current EGFR mutation status, % Mutant Wildtype Unknown PD-L1 quantifiable, N (%) 1%, n/n (%) 5%, n/n (%) 10%, n/n (%) 25%, n/n (%) 50%, n/n (%) Hellmann et al (82) 21/31 (68) 16/31 (52) 13/31 (42) 10/31 (32) 6/31 (19) (77) 23/30 (77) 19/30 (63) 15/30 (50) 8/30 (27) 7/30 (23) EGFR and ALK positive patients not excluded from this study Patients are included regardless of PD-L1 expression (88) 32/46 (70) 26/46 (57) 20/46 (42) 18/46 (39) 12/46 (26) NSCLC CM
25 Opdivo + Yervoy: Enhanced Efficacy with Increasing Levels of PD-L1 Expression NSCLC CM Opdivo 3 Q2W + Yervoy 1 Q6/12W (pooled) Opdivo 3 Q2W ORR (%) n PD-L1 expression Hellmann et al 0 77 All <1% % % % % % 12 All <1% 1% 5% 10% 25% 50% Opdivo + Yervoy showed clinically meaningful response rates with the potential to improve long term survival. 25
26 CheckMate-012 Efficacy by PD-L1 Expression ORR, % <1% PD-L1 1% PD-L1 50% PD-L1 Median PFS, mo <1% PD-L1 1% PD-L1 50% PD-L1 1-year OS rate, % <1% PD-L1 1% PD-L1 50% PD-L1 Opdivo 3 Q2W + Yervoy 1 Q12W (n = 38) NC 90 NC Opdivo 3 Q2W + Yervoy 1 Q6W (n = 39) NR NC Median follow-up, mos Platinum Doublets, all arms NR = Not Reached NC = Not Calculated Hellmann et al Opdivo Mono 3 Q2W (n = 52) Adding Yervoy to Opdivo increased ORR, median PFS, and 1-year OS in PD-L1 expressers NSCLC CM
27 Depth and Durability of Response NSCLC CM-012 Change in Target Lesion Size From Baseline (%) Nivo 3 Q2W + Ipi 1 Q6W No response (PD + SD) Response First response Hellmann et al Time (Months) 12/15 responders (80%) in the Q6W arm and 14/18 responders (78%) in the Q12W arm had a response by time of first scan (week 11) 12/15 responders (80%) in the Q6W arm and 12/18 responders (67%) in the Q12W had an ongoing response at time of database lock PD = progressive disease; SD = stable disease Includes all patients with baseline target lesion and 1 post-baseline assessment of target lesion (n = 33) 27
28 Summary of -012 Safety NSCLC CM-012 Odp 3 Q2W + Yer 1 Q12W (n = 38) Any grade Grade 3 4 Opd 3 Q2W + Yer 1 Q6W (n = 39) Any grade Grade 3 4 Opd 3 Q2W (n = 52) Any grade Grade 3 4 Treatment-related AEs, % Treatment-related AEs leading to discontinuation, % No treatment-related deaths. Improved safety and tolerability observed with current Opdivo and Yervoy combination cohorts compared to those previously studied. Hellmann et al 28
29 Checkmate-227: Opdivo + Yervoy in First line NSCLC NSCLC Opdivo 3 Q2W Yervoy 1 Q6W PD-L1 Expressors Opdivo 240 mg Q2W 1L NSCLC Chemo doublet Sq: Opdivo + gemcitabine + carbo/cis Non-sq: Opdivo + pemetrexed + carbo/cis Co-primary endpoints: PFS/OS PD-L1 Non-Expressors Opdivo 3 Q2W Yervoy 1 Q6W Chemo doublet 29
30 Small Cell Lung Cancer (SCLC) 30
31 Small Cell Lung Cancer (SCLC) High Unmet Need: Aggressive tumor with very poor outcomes No improvement beyond chemotherapy for last 20+ years Platinum-based therapy in first line is established with high response rate but fast relapse for most patients Stage Distribution at Diagnosis 1 30% 70% Extensive Stage Disease (ED- SCLC) Limited Stage Disease (LD-SCLC) Development Approach in SCLC: Phase 3 study of Opdivo monotherapy in second line vs. standard of care (CM-331); primary endpoint OS Phase 3 study of Opdivo monotherapy or Opdivo/Yervoy combination therapy followed by Opdivo as maintenance post chemo in first line vs. placebo (CM-451); co-primary endpoints OS/PFS 1. Morabito A et al. Crit Rev Oncol Hematol. 2014;91(3): Lally BE et al. The Oncologist. 2007;12(9): % 12% 10% 8% 6% 4% 2% 0% 5-Year Relative Survival 2 1 2% ED-SCLC 10-13% 10 13% LD-SCLC 31
32 CheckMate-032: Study Design (SCLC) SCLC CM-032 Open-label, multicenter phase I/II study Patients with progressive disease after 1 prior line of therapy including first-line platinum-based regimen Opdivo 3 Q2W (n = 98) Opdivo 1 + Yervoy 3 Q3W for 4 cycles (n = 61) Opdivo 3 + Yervoy 1 Q3W for 4 cycles (n = 54) Opdivo 3 Q2W 32
33 Opdivo + Yervoy: Higher Response Rates SCLC CM-032 Opdivo 3 (n = 98) Opdivo 1 + Yervoy 3 (n = 61) Opdivo 3 + Yervoy 1 (n = 54) Objective response rate, % Overall Platinum-sensitive Platinum-resistant Best overall response, % Complete response Partial response Stable disease Progressive disease Unable to determine Not evaluable (no tumor assessment follow-up) Antonia et al 33
34 Depth and Durability of Responses SCLC CM-032 Opdivo 3 Opdivo 1 + Yervoy 3 Opdivo 3 + Yervoy 1 Percentage Change From Baseline (%) Time (Weeks) Time (Weeks) Time (Weeks) Confirmed Partial Response or Complete Response Patients off treatment First occurrence of new lesion % change truncated to 100% Antonia et al 34
35 Responses Observed Regardless of PD-L1 Expression SCLC CM-032 Best change from baseline in target lesion volume (%) Opdivo 3 Opdivo 1 + Yervoy 3 Opdivo 3 + Yervoy 1 Patients Patients Patients <1% PD-L1 1% PD-L1 PD-L1 not evaluable/missing Confirmed responders % change truncated to 100% 69% were evaluable for PD-L1 expression at baseline 16% had 1% tumor PD-L1 expression Antonia et al 35
36 Overall Survival SCLC CM-032 Events/ Number at risk mos, months 1-year OS rate, % Opdivo 3 Opdivo 1 / Yervoy 3 Opdivo 3 / Yervoy 1 60/98 36/61 35/ OS (% of Patients) % 33% 43% Time (Months) Opdivo + Yervoy regimen showed encouraging one-year overall survival. Antonia et al 36
37 Summary of -032 SCLC Safety SCLC CM-032 Any grade, % Opdivo 3 (n = 98) Grade 3 4, % Opdivo 1 + Yervoy 3 (n = 61) Any grade, % Grade 3 4, % Opdivo 3 + Yervoy 1 (n = 54) Any grade, % Grade 3 4, % Total treatmentrelated AEs Fatigue Pruritus Diarrhea Nausea Decreased appetite Hypothyroidism Hyperthyroidism Rash Rash, maculopapular Lipase increased Treatment-related AEs leading to discontinuations Antonia et al 3 treatment-related deaths 37
38 Urothelial (Bladder) 38
39 CheckMate-032:Study Design (Urothelial) Bladder CM-032 Open-label, multicenter phase I/II study Patients with metastatic/locally advanced urothelial carcinoma Opdivo 3 Q2W (n = 78) Opdivo 1 + Yervoy 3 Q3W for 4 cycles (n = 26) Opdivo 3 + Yervoy 1 Q3W for 4 cycles (n = 105) Opdivo 3 Q2W 39
40 CheckMate-032: Promising Objective Responses Regardless of PD-L1 Expression Bladder CM-032 Responses ORR, % (95% CI) Best overall response, % Opdivo (n = 78) 24.4 ( ) Complete response 6.4 Partial response 17.9 Stable disease 28.2 Progressive disease 38.5 Unable to determine 9.0 ORR, % (95% CI) by PD-L1 expression PD-L1 <1% 26.2 ( ) PD-L1 1% 24.0 ( ) Sharma et al 40
41 Summary of Safety -032 Bladder Bladder CM-032 TRAEs = Treatment-Related Adverse Events Sharma et al Opdivo (n = 78) Any grade Grade 3 4 TRAEs in 10% of patients, % Fatigue 36 3 Pruritus 30 0 Lipase elevated 14 5 Rash, maculopapular 18 3 Nausea 13 1 Arthralgia 12 0 Anemia 10 0 Select TRAEs, % Gastrointestinal 10 1 Hepatic 5 1 Pulmonary 3 0 Renal 9 1 Skin 42 3 Two treatment-related deaths 41
42 Colorectal Cancer Microsatellite Instability High (CRC MSI-H) 42
43 Hypermutation and Immuno-Oncology CRC MSI-H CM-142 In CRC, microsatellite instability (MSI) is associated with: Elevated neoantigen load Increases in immune infiltration and expression of immune checkpoint regulators 1,2 Strong rationale for checkpoint inhibitor blockade in CRC and other MSI-H tumors (e.g. gastric, endometrial) 1. Llosa NJ, et al. Cancer Discov. 2015;5: Giannakis M, et al. Cell Reports. 2016;15:
44 Progression-Free Survival with Opdivo + Yervoy and Opdivo Monotherapy Progression-Free Survival (% of patients) 100 No. at Risk PFS rate, % (95% CI) 6 mo 9 mo 12 mo Median PFS, mo (95% CI) Months Opdivo 3 (n = 70) 45.9 (29.8, 60.7) 45.9 (29.8, 60.7) 45.9 (29.8, 60.7) CRC MSI-H CM-142 Opdivo 3 + Yervoy 1 (n = 30) 66.6 (45.5, 81.1) NE NE 5.3 (1.5, NE) NE (3.4, NE) Opdivo Opdivo + Yervoy Overman et al 44
45 Overall Survival with Opdivo + Yervoy and Opdivo Monotherapy Overall Survival (% of patients) Months No. at Risk Opdivo Opdivo + Yervoy Overman et al OS rate, % (95% CI) 6 mo 9 mo 12 mo Median OS, mo (95% CI) Opdivo 3 (n = 70) 75.0 (58.5, 85.7) 65.6 (48.0, 78.6) 65.6 (48.0, 78.6) 0 CRC MSI-H CM-142 Opdivo 3 + Yervoy 1 (n = 30) 85.1 (65.0, 94.2) 85.1 (65.0, 94.2) NE 17.1 (8.6, NE) NE (NE, NE) 0 45
46 Other Key Data Head and Neck CheckMate-141 Hepatocellular Carcinoma CheckMate-040 Hodgkin Lymphoma CheckMate-205 (Cohort B) Glioblastoma CheckMate-143 (Cohort 1 and 1b) Gastric Cancer CheckMate-032 Phase 3 study evaluating Opdivo versus investigator s choice in patients with recurrent/metastatic platinum-refractory SCCHN Results: Meaningful improvement in OS regardless of PD-L1 and HPV status; safety consistent with prior studies Regulatory filings under way Phase 1/2 study evaluating safety and antitumor activity of Opdivo in patients with advanced hepatocellular carcinoma Results: Encouraging responses, duration of response, and OS data in tumor with high unmet medical need First PD-1 approved in hematological malignancies Results: Durable and high response rates; majority of responses ongoing at analysis Approved in US; under review in EU and Japan High unmet need with limited therapeutic options Encouraging efficacy and safety of Opdivo monotherapy and Opdivo plus Yervoy regimen in recurrent GBM High unmet need Encouraging activity with Opdivo monotherapy and Opdivo plus Yervoy regimen, regardless of PD-L1 expression Phase 3 of Opdivo 1 + Yervoy 3 planned 46
47 : Key Takeaways Unprecedented first line lung data with Opdivo and Yervoy in PD-L1 expressers Broadening the Potential Benefit of Opdivo + Yervoy Redefining the Potential for Long-Term Survival Promise of I-O in additional tumors 47
48 The Next Generation of Transformational Innovation in Immuno-Oncology Mike Burgess Head of Exploratory Clinical and Translational Research 48
49 A High Bar for Success Continuing to Deliver Transformational Research Transforming cancer care with Opdivo & Yervoy Learn and adapt to evolving landscape Follow the science with a deep portfolio Focus on unmet medical needs Focused on longterm survival PATIENT Strive to develop new therapies Rapid and robust decision making Innovative designs for speed and execution High bar for success 49
50 Striving to Develop New Therapies as the Future Standards of Care Broad Portfolio Three Pillars for Success with New Agents and Emerging Science Innovative and Efficient Trial Design Strong Translational Research 50
51 At the Forefront of Science Exploring New Mechanisms Broad Portfolio *Targets are listed by primary mechanisms. Secondary mechanisms may exist. 51
52 At the Forefront of Science Exploring Effector T-Cell Mechanisms T cell Broad Portfolio Activating CD137 GITR OX40 Inhibitory CTLA4 PD1 Lag3 *Targets are listed by primary mechanisms. Secondary mechanisms may exist. 52
53 At the Forefront of Science Exploring NK Cell Mechanisms Broad Portfolio Activating SLAMF7 CD137 Inhibitory KIR NK cells *Targets are listed by primary mechanisms. Secondary mechanisms may exist. 53
54 At the Forefront of Science Exploring Non Effector Cell Mechanisms Regulatory T cell Tumor associated macrophage Dendritic cell (APC) Broad Portfolio Inhibitory CD73 CSF1R IDO CTLA4 *Targets are listed by primary mechanisms. Secondary mechanisms may exist. 54
55 At the Forefront of Science Exploring Tumor Cell Targeted Pathways Broad Portfolio BCR-ABL BET CXCR4 Fucosyl-GM1 HER2 Mesothelin (ADC) Glypican-3 (ADC) Tumor cells *Targets are listed by primary mechanisms. Secondary mechanisms may exist. 55
56 At the Forefront of Science Exploring New Mechanisms Effector T-Cell Mechanisms Activating CD137 GITR OX40 Inhibitory CTLA4 PD1 Lag3 NK Cell Mechanisms Activating SLAMF7 CD137 Inhibitory KIR Broad Portfolio Non Effector Cell Mechanisms Inhibitory CD73 CSF1R IDO CTLA4 Tumor Cell Targeted Pathways BCR-ABL BET CXCR4 Fucosyl-GM1 HER2 Mesothelin (ADC) Glypican-3 (ADC) 56
57 Following the Patient Experience with Innovative Clinical Trial Design The FRACTION * Program Innovative and Efficient Trial Design I-O therapy naive Patients with advanced NSCLC (squamous & non-squamous) PDL1+ PDL1- Opdivo monotherapy Innovative design to efficiently evaluate I-O combos for delivery of transformational effects I-O therapy experienced Opdivo+ X Combo New Opdivo Combo Novel Combo X+Y Opdivo+ Y Combo Opdivo+ Z Combo Triple Combo Ability to explore potential benefits across range of patients New investigational treatments administered based on patient response *Fast Real-time Assessment of Combination Therapy in Immuno-ONcology Program 57
58 Strong Translational Understanding Biologic and Research Translational Science A Holistic Approach THE TUMOR AS AN ORGAN FOUNDATIONAL SCIENCE I-O UP-INVESTMENT Pathology Genomics Proteomics Flow Cytometry Sample Management Biomarkers that predict response INTEGRATION OF DATA TO EMPOWER: Resistance mechanisms New targets and rational combinations Optimal diagnostics 58
59 Transforming Cancer Care for Patients Progress on Next Generation Therapies Disclosures in 2016 Planned for ESMO or SITC 2016 Lirilumab /Urelumab Safety and preliminary efficacy of combinations including Opdivo Anti-LAG3 Safety and PK/PD of monotherapy and combination with Opdivo Anti-Fucosyl-GM1 Safety, PK/PD and preliminary efficacy Potential Disclosures in 2017 Data Updates Lirilumab Urelumab Anti-LAG3 Anti-Fucosyl-GM1 New Assets Anti-CSF1R IDOi Anti-GITR Anti-CD73 Mesothelin-ADC BETi 59
60 Unwavering Focus on Patients and Commitment to Quality Science Focused on improving outcomes for: Rapidly progressing disease Resistant & Refractory disease Sub-optimal response Pursuing next generation transformational opportunities across a broad range of disease areas and modalities Pioneering I-O therapies to continue our leadership Diverse early portfolio of immunological mechanisms of action 10 clinical stage I-O molecules by early targeted oncology clinical stage molecules 60
61 ASCO 2016 * Investor Meeting June 4, 2016 *American Society of Clinical Oncology, June 3-7,
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