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ASCO 2018 Investor Meeting
June 4, 2018
Investor Meeting June 4, 2018 NOT FOR PRODUCT PROMOTIONAL USE 1 - - PowerPoint PPT Presentation
ASCO 2018 Investor Meeting June 4, 2018 NOT FOR PRODUCT PROMOTIONAL USE 1 Forward-Looking Information This presentation contains statements about the Companys future plans and prospects that constitute forward-looking statements for
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June 4, 2018
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This presentation contains 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 1995. 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 the date hereof and should not be relied upon as representing our estimates as of any subsequent
we specifically disclaim any obligation to do so, even if our estimates change.
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Note: All milestones since 2014
Tumors with
registrational trials
Positive Registrational Trials
Phase III trials stopped early due to survival benefit
New England Journal of Medicine Publications Global Approvals for Opdivo
Breakthrough Therapy Designations U.S. Approved Indications
2 4 6 8 10
Opdivo
Avastin Taxotere
12 14
Years
in
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Leveraging Translational Medicine and Cancer Biology Significant Registrational Readouts Comprehensive Next-Wave Pipeline
Cambridge 2018 Resistance Next-Gen Checkpoints Non-Effector Cells Activating Mechanisms Tumor Cell Pathways OS Readouts in NSCLC HCC, SCLC, Gastric, SCCHN, Bladder, Esophageal Adjuvant Program
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Maximize T-cell Responses Modify Key Resistance Mechanisms Promote Tumor Inflammation Target Tumor Cells Directly
x
x x
TUMOR CELLS STROMA EFFECTOR CELLS Block inhibitory immune checkpoints
PD-1 LAG-3 TIM-3 CTLA-4 CTLA-4-Probody TIGIT
Activate effector T-cells
GITR OX40 CD137 ICOS CD27 IL-2
Enhance NK-cell activity
KIR SLAMF7
Target tumor cell pathways
BCR-ABL DR5 TKIs CXCR4 BET ADCs
Block inhibitory stromal effects
CCR2/5 IL-8
Innate immune activators
NLRP3 STING EFFECTOR CELL
IMMUNE REGULATION Block or deplete immune regulators
EP4 Glutaminase CTLA-4-NF CCR4 TGFR IDO1 CD73 CSF1R
ANTIGEN PRESENTATION Optimize oncolysis and antigen production
Radiation Chemotherapy CD80/aCD3 OV Viruses Vaccines CD40
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potentially improves safety via T-reg proliferation in the periphery
–PK/PD profile results in improvements in safety profile including in combination with Opdivo
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Translational Medicine Tumor Types
Early/New Assets
New combinations (NIVO + new MoA)
NIVO + IPI
DISCUSSIONS
HEOR
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– Monotherapy, IO/Chemo, and IO/IO
– Histology, driver mutations, I-O markers: PD-L1, TMB, future markers
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patients
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Nivo + chemo (n = 177) Chemo (n = 186) Median PFS,mo 5.6 4.7 HR (95% CI) 0.74 (0.58, 0.94) Nivolumab + chemotherapy Chemotherapy
1-y PFS = 26% 1-y PFS = 14%
20 40 60 80 100 6 12 18 3 9 15 21 PFS (%) Months
All Randomized Patients in Part 1b (PD-L1<1%)
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1-y PFS = 16% Nivo + Chemo Nivo + Chemo (n = 54) Nivo + Ipi (n = 52) Chemo (n = 59) Median PFS, mo 4.7 3.1 4.7 HR (vs chemo) (95% CI) 0.87 (0.57, 1.33) 1.17 (0.76, 1.81) Nivo + Ipi 1-y PFS = 18% 1-y PFS = 18%
Months
Chemo
TMB <10 mut/Mb and <1% Tumor PD-L1 Expression TMB ≥10 mut/Mb and <1% Tumor PD-L1 Expression
Nivo + Chemo (n = 43) Nivo + Ipi (n = 38) Chemo (n = 48) Median PFS, mo 6.2 7.7 5.3 HR (vs chemo) (95% CI) 0.56 (0.35, 0.91) 0.48 (0.27, 0.85)
PFS (%)
Nivo + Chemo
Months
1-y PFS = 45% 1-y PFS = 27%
20 40 60 80 100 6 12 18 3 9 15 21
Chemo 1-y PFS = 8% Nivo + Ipi
20 40 60 80 100 6 12 18 3 9 15 21
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Nivo + Chemo (n = 26) Nivo + Ipi (n = 14) Chemo (n = 10) Median DOR, mo 7.4 NR 4.4
DOR: TMB ≥10 mut/Mb and <1% Tumor PD-L1 Expression
Months
Nivo + Ipi Nivo + Chemo ≥1-y DOR = 33% ≥1-y DOR = 93%
Chemo ≥1-y DOR = NC
100 80 60 40 20 3 6 9 12 15 18 21
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Trial Status CM-227 (Part 1a) Late 2018/ Early 2019 CM-227 – TMB OS Ongoing CM-227 (Part 2) 2019 CM-9LA 2H2019
Tumor/ Trial Expected Timing* HCC CM-459 2H 2018 SCLC CM-331 2H 2018 CM-451 2H 2018 Gastric CM-649 2019 Head & Neck CM-651 2020** CM-714 2019 Bladder CM-901 1H 2020 Esophageal CM-648 1H 2020
*Per clinicaltrials.gov
Tumor/ Trial Expected Timing* Melanoma CM-915 2020 Bladder CM-274 2020 Esophageal CM-577 2020 Renal CM-914 2022 Head & Neck CM-9TM 2022 Lung CM-816 2023
**clinicaltrials.gov update pending
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June 4th, 2018