Cowen Health Care Conference - s21.q4cdn.com · Cowen Health Care Conference March 7, ... annual...
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NOT FOR PRODUCT PROMOTIONAL USE Cowen Health Care Conference March 7, 2016 Dr. Fouad Namouni Head of Medical 1
Transcript of Cowen Health Care Conference - s21.q4cdn.com · Cowen Health Care Conference March 7, ... annual...
NOT FOR PRODUCT PROMOTIONAL USE
CowenHealth Care Conference
March 7, 2016
Dr. Fouad NamouniHead of Medical
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NOT FOR PRODUCT PROMOTIONAL USE
Forward-Looking InformationThis 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 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.
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NOT FOR PRODUCT PROMOTIONAL USE
Our R&D Strategic Focus
DISEASE AREA FOCUSGenetically
Defined DiseasesOncology
Immunoscience
Cardiovascular
FibroticDiseases
Monogenic diseases
Heart Failure Thrombosis
RA, IBD,Lupus Lung
Liver
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Potentially Transformational Treatment Effect
Enduring Unmet Need
High Severity
BMS Development Strategy
High Disease Severity
Potentially Large
TreatmentEffect
Enduring Unmet Need
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2015: Leading in Immuno-Oncology
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Early Trial Stops3FDA Approvals7
43 Global Approvals
7 NEJM Articles
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Diversifying in Immuno-Oncology
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Patients who do not respondto Opdivo +/- Yervoy
Patients who progress after treatment with Opdivo +/- Yervoy
Additional tumors, including where signals are not sufficient
Improve outcomes through combinations
Next wave of innovation: addressing unmet need
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8 Additional I-O Assetsin Clinical
Development
2016: Diversifying in Immuno-Oncology
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NK cell
T cell
BMS assets beginning clinical studies in 2016
Tumor Microenvironment
T Cell Activation
NK Cell Activation
Next wave of innovation: areas of focus
Priming & Activation
AntigenPresentation
AntigenRelease
T Cell Trafficking and Infiltration
anti-CSF1R IDO
anti-CD73
anti-LAG3
Urelumab(anti-CD137)
anti-GITR
anti-OX40
Lirilumab(anti-KIR)
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Medical Insights
MELANOMA
LUNG
RENAL
• Only PD-1 indicated for all 2nd lineNSCLC patients in US, EU*, and JP
• No testing requirement
• Strong access and reimbursement
• Broad range of treatment options
• First I-O combination regimen approved
• First I-O agent in 2nd line in US and EU*
• Meaningful improvement over a standard of care
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* Non-squamous NSCLC and RCC indications are the subject of positive CHMP opinions in the EU and are awaiting EU Commission approval.
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Strong Access Position
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• Global Recognition of Value
• Unprecedented Speed
• Able to treat a broad number of patients
Opdivo
Select EU Products
Months to patient access post approval
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2016: Key Events
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Tumor Study Design 1L NSCLC
CheckMate -026Monotherapy vs. chemo in first-line PD-L1 expressers
Hodgkin LymphomaCheckMate -205
Monotherapy single arm study insecond line
Head and NeckCheckMate -141
Monotherapy vs. standard of care in second line (Study stopped for survival advantage)
BladderCheckMate -275
Monotherapy single arm study insecond line bladder
GlioblastomaCheckMate -143
Monotherapy vs. standard of carein recurrent glioblastoma
Non-Hodgkin Lymphoma
CheckMate -139
Monotherapy single-arm study in relapsed/refractory diffuse largeB-cell lymphoma
Potentially Registrational Data
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Scientific Data Generation
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Includes Opdivo and Yervoy studies.
Region US Ex-US
BMS Sponsored 7 5
ISR 110 63
Other 39 72
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Checkmate-153: Advancing the Science in 2L NSCLC
AdvancedNSCLC
(NSQ and SQ)
At least1 prior
systemic therapy
~1,400 Patients
COHORT BDiscontinue treatment at1 year, allowre-treatment
COHORT A Treat to progression, unacceptable toxicity, or withdrawal
Nivo3 mg Q2 wkly
Patient Subgroups:• PS status• Number of prior
therapies • Treated CNS Mets
At1 Year
Primary Endpoint: Safety
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Checkmate-370: Advancing the Science in 1L NSCLC
Non-SquamEGFRwt, ALKwt
Squam
Non-Squam & SquamFirst Line
EGFRwt, ALKwt
Non-small Cell Lung Cancer
(NSCLC)Local Advanced
or Stage IV , NSQ and SQ
~2,000 PatientsFirst LineEGFRmut
First Line ALKmut
• Mono or combo with chemo vs chemo
• Mono vs best supportive care
• Mono vs. Chemo
• Combo with erlotinibvs erlotinib
• Combo with crizotinib
Opdivo as maintenance
Opdivo as first-line treatment
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Master Trial Agreements with Key Centers
InternationalImmuno-OncologyNetwork
Rare Population Malignancies Research Programs with Leading Academic Institutions
Leading Through Partnerships
Royal Marsden
UniversityCollege London
UniversityGustaveRoussy
NetherlandsCancerInstitute
WTZEssen
NCCJapanNCI
Naples
Universityof Navarra
Dana FarberCancerInstituteMemorial
Sloan-KetteringCancer Center
Johns HopkinsUniversity
Earle A. ChilesResearchInstitute
Universityof Chicago
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Working Together for Patients
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CowenHealth Care Conference
March 7, 2016
Dr. Fouad NamouniHead of Medical
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