bristol myerd squibb American Society of Clinical Oncology (ASCO) Highlights

1Not For Promotional Use

ASCO 2008 Highlights*ASCO 2008 Highlights*

Investor TeleconferenceJune 2, 2008


*American Society of Clinical Oncology, May 30 – June 3, 2008*American Society of Clinical Oncology, May 30 – June 3, 2008


Comments will be about the CompanyComments will be about the Company’’s future plans and s future plans and prospects that may be forwardprospects that may be forward--looking statements under looking statements under thethe Private Securities Litigation Reform Act of 1995.Private Securities Litigation Reform Act of 1995.We caution that actual results may differ materially from We caution that actual results may differ materially from those indicated by these forwardthose indicated by these forward--looking statements aslooking statements asa result of various important factors, including those a result of various important factors, including those discussed in the Companydiscussed in the Company’’s most recent annual report on s most recent annual report on Form 10Form 10--K, periodic reports on Form 10K, periodic reports on Form 10--Q and current Q and current reports on Form 8reports on Form 8--K. These documents are available from K. These documents are available from the SEC, the Bristolthe SEC, the Bristol--Myers Squibb web site or fromMyers Squibb web site or fromBristolBristol--Myers Squibb Investor Relations. While we may elect Myers Squibb Investor Relations. While we may elect to update forwardto update forward--looking statements at some point in the looking statements at some point in the future, we specifically disclaim any obligation to do so,future, we specifically disclaim any obligation to do so,even if our estimates change. even if our estimates change.


ASCO 2008 Highlights ASCO 2008 Highlights –– AgendaAgenda

More than 100 Abstracts at ASCO 2008More than 100 Abstracts at ASCO 2008

ErbituxErbitux®®

SPRYCELSPRYCEL®®

IpilimumabIpilimumab

IXEMPRAIXEMPRATMTM

BrivanibBrivanib

CTCT--322322


ASCO Highlights ASCO Highlights –– ErbituxErbituxData presented from 64 abstracts covered a varietyData presented from 64 abstracts covered a varietyof tumor typesof tumor types

Colorectal cancer (CRC)Colorectal cancer (CRC) . . . . .. . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . 2222Head and neck cancerHead and neck cancer . . . . . .. . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . 1010Upper GI cancer including pancreas, Upper GI cancer including pancreas, esophageal and gastricesophageal and gastric . . . . . .. . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . 6 6 NonNon--small cell lung cancer (NSCLC)small cell lung cancer (NSCLC) . . . . . . . . . . 66Other tumors Other tumors . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . 2020

Two plenary presentations, a first at ASCO forTwo plenary presentations, a first at ASCO forany given drug:any given drug:

FirstFirst--line NSCLC (FLEX): Improved survival inline NSCLC (FLEX): Improved survival inbroad populationbroad populationKRAS in firstKRAS in first--line CRC (CRYSTAL): Improved PFSline CRC (CRYSTAL): Improved PFSin wildin wild--type KRAStype KRAS


ErbituxErbitux –– FLEXFLEXRandomized, multiRandomized, multi--center, Phase III study of center, Phase III study of cetuximabcetuximab in combination with in combination with cisplatin/vinorelbinecisplatin/vinorelbineversus versus cisplatin/vinorelbinecisplatin/vinorelbine alone in the firstalone in the first--line line treatment of patients with advanced NSCLCtreatment of patients with advanced NSCLCPrimary endpoint:Primary endpoint:

–– Overall survivalOverall survivalSecondary endpoints:Secondary endpoints:

–– ResponseResponse–– ProgressionProgression--free survival free survival –– Disease controlDisease control–– Quality of lifeQuality of life–– SafetySafety


ErbituxErbitux –– FLEX: FLEX: Overall Overall SurvivalSurvival

MonthsPatients at riskPatients at riskCTCT 568568 383383 225225 134134 4848 00CT + CetuximabCT + Cetuximab 557557 383383 251251 155155 5353 33

Ove

rall

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p-value = stratified log-rank test (2-sided)

Median OSMedian OS11--year year

survivalsurvival▬▬ CT + CetuximabCT + Cetuximab

(n=557)(n=557) 11.3 months11.3 months 47 %47 %

▬▬ CTCT(n=568)(n=568) 10.1 months10.1 months 42 %42 %

HR = 0.871 (95% CI 0.762HR = 0.871 (95% CI 0.762––0.996)0.996)pp--value = 0.044value = 0.044

FLEX, Pirker, et. al., ASCO, 2008


ErbituxErbitux –– FLEX:FLEX:PrePre--specified subgroup analysisspecified subgroup analysis

Survival benefit was seen across all Survival benefit was seen across all major subgroupsmajor subgroups

ECOG performance statusECOG performance statusSmoking statusSmoking statusHistologyHistologyGenderGenderAgeAgeTumor stageTumor stage


Other: includes large cell, Other: includes large cell, adenosquamousadenosquamous, undifferentiated, undifferentiated

Median OS (monthsMedian OS (months))

CT + CetuximabCT + Cetuximab CTCT HR [95% CI]HR [95% CI]Caucasian Caucasian (n=946)(n=946) 10.510.5 9.19.1 0.8030.803

[0.694[0.694––0.928]0.928]AdenoAdeno(n=413) (n=413) Squamous cell Squamous cell (n=347)(n=347) 10.210.2 8.98.9 0.7940.794

[0.626[0.626––1.007]1.007]

Other Other (n=185)(n=185)

12.012.0 10.310.3 0.8150.815[0.649[0.649––1.023]1.023]

9.09.0 8.28.2 0.8070.807[0.584[0.584––1.115]1.115]

ErbituxErbitux –– FLEX: Overall Survival FLEX: Overall Survival Major Treatment Group: Caucasians Major Treatment Group: Caucasians (n=946)(n=946)PrePre--specified Analysisspecified Analysis



ErbituxErbitux –– FLEX: FLEX: SSafetyafety ProfileProfileAdverseAdverse EventsEventsGrade 3/4Grade 3/4

CT + Cetuximab CT + Cetuximab (n=548)(n=548)

CTCT(n=562)(n=562)

Any eventAny event 91 %91 % 86 %86 %

NeutropeniaNeutropenia 53 %53 % 51 %51 %

InfusionInfusion--related reactionsrelated reactions 4 %**4 %** <1%<1%

Febrile Febrile neutropenianeutropenia 22 %22 % 15 %15 %

AnemiaAnemia 14 %14 % 17 %17 %

AcneAcne--like rash (only grade 3)*like rash (only grade 3)* 10 %10 % <1%<1%

DiarrheaDiarrhea 5 %5 % 2 %2 %

TreatmentTreatment--related deathsrelated deaths 3 %3 % 2 %2 %

*There were no grade 4 skin reactions**Allergy/Anaphylaxis 3%



ErbituxErbitux –– CRYSTAL KRAS AnalysisCRYSTAL KRAS Analysis

CRYSTAL was a Phase III study in firstCRYSTAL was a Phase III study in first--line line metastaticmetastatic CRC which compared CRC which compared cetuximabcetuximab plus plus FOLFIRI to FOLFIRI alone. Results of the study FOLFIRI to FOLFIRI alone. Results of the study showed that showed that cetuximabcetuximab plus FOLFIRI met the plus FOLFIRI met the primary endpoint of increasing median duration of primary endpoint of increasing median duration of progressionprogression--free survival (PFS) over FOLFIRI alonefree survival (PFS) over FOLFIRI alone

A retrospective analysis investigated the impact on A retrospective analysis investigated the impact on response rate and PFS of the KRAS mutation status response rate and PFS of the KRAS mutation status of tumors in the firstof tumors in the first--line treatment of line treatment of metastaticmetastaticCRC treated with FOLFIRI CRC treated with FOLFIRI ±± cetuximabcetuximab


ErbituxErbitux –– Relating KRAS Status to Efficacy: Relating KRAS Status to Efficacy: Data QualityData Quality

587 subjects analyzed for KRAS mutation status587 subjects analyzed for KRAS mutation status

540 subjects: KRAS evaluable population540 subjects: KRAS evaluable population

348 (64.4%) KRAS wild348 (64.4%) KRAS wild--typetype 192 (35.6%) KRAS mutant192 (35.6%) KRAS mutant

171 subjects with events (49.1%)171 subjects with events (49.1%)

Group Group A:A:105105 (54.7%)(54.7%)

Group Group B:B:8787 (45.3%)(45.3%)

101 subjects with events (52.6%)101 subjects with events (52.6%)

1198 subjects (ITT)1198 subjects (ITT)

Group Group A:A:172172 (49.4%)(49.4%)

Group Group B:B:176176 (50.6%)(50.6%)

FOLFIRIFOLFIRICetuximab + FOLFIRICetuximab + FOLFIRI



ErbituxErbitux –– Relating KRAS Status to Efficacy: Relating KRAS Status to Efficacy: Primary Endpoint Primary Endpoint –– PFS, KRAS WildPFS, KRAS Wild--TypeType

KRAS wild-type HR=0.68; p = 0.017mPFS Cetuximab + FOLFIRI: 9.9 monthsmPFS FOLFIRI: 8.7 months

0.0

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CRYSTAL, Van Cutsem, et. al., ASCO, 2008

13Not For Promotional UseCRYSTAL, Van Cutsem, et. al., ASCO, 2008

ErbituxErbitux –– Relating KRAS Status to Efficacy: Relating KRAS Status to Efficacy: Primary Endpoint Primary Endpoint –– PFS, KRAS MutantPFS, KRAS Mutant

KRAS mutant HR=1.07; p = 0.47mPFS Cetuximab + FOLFIRI: 7.6 monthsmPFS FOLFIRI: 8.1 months

0.0

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KRAS wildKRAS wild--typetype KRAS mutantKRAS mutant

FOLFIRIFOLFIRIn=176 (%)n=176 (%)

Cetuximab + Cetuximab + FOLFIRIFOLFIRI

n=173 (%)n=173 (%)FOLFIRIFOLFIRIn=87 (%)n=87 (%)

Cetuximab + Cetuximab + FOLFIRIFOLFIRI

N=105 (%)N=105 (%)

Any Any 50.650.6 78.078.0 55.255.2 72.472.4

NeutropeniaNeutropenia 16.516.5 25.425.4 23.023.0 21.921.9Febrile Febrile neutropenianeutropenia 0.60.6 0.60.6 00 3.83.8

DiarrheaDiarrhea 9.19.1 17.317.3 12.612.6 13.313.3

VomitingVomiting 2.82.8 4.64.6 6.96.9 2.92.9

FatigueFatigue 4.54.5 2.32.3 2.32.3 9.59.5

Acne like Acne like rashrashaa 00 16.216.2 00 17.117.1

InfusionInfusion--related reactionsrelated reactions 00 1.71.7 00 3.83.8

aaThereThere was no grade 4 acnewas no grade 4 acne--like rashlike rash

ErbituxErbitux –– Relating KRAS Status to Outcome:Relating KRAS Status to Outcome:Most Common Grade 3/4 Adverse EventsMost Common Grade 3/4 Adverse Events

CRYSTAL, Van Cutsem, et. al., ASCO, 2008


ErbituxErbitux –– ASCO Key TakeawaysASCO Key TakeawaysFLEXFLEX

First antiFirst anti--EGFR to prolong survival in broad population of EGFR to prolong survival in broad population of NSCLC patientsNSCLC patientsCetuximabCetuximab added to firstadded to first--line chemotherapy withline chemotherapy withcisplatincisplatin / / vinorelbinevinorelbine demonstrated superior overall survival demonstrated superior overall survival compared to chemotherapy alone in patients with advanced compared to chemotherapy alone in patients with advanced EGFREGFR--expressing NSCLCexpressing NSCLCSide effects were similar to those observed in previous trials Side effects were similar to those observed in previous trials and manageable with acneand manageable with acne--like skin rash as the most common like skin rash as the most common cetuximabcetuximab--related side effectrelated side effect

CRYSTAL KRAS AnalysisCRYSTAL KRAS AnalysisFirst antiFirst anti--EGFR to show additional PFS benefit in patients with EGFR to show additional PFS benefit in patients with wildwild--type KRAS CRC as firsttype KRAS CRC as first--line treatment in combination with line treatment in combination with chemotherapychemotherapyThe grade 3/4 adverse event profile was similar in the KRAS The grade 3/4 adverse event profile was similar in the KRAS evaluableevaluable and overall populationsand overall populations


Regulatory filings planned:Regulatory filings planned:FirstFirst--line line metastaticmetastatic head & neck: EXTREMEhead & neck: EXTREMEFirstFirst--line advanced NSCLC: FLEXline advanced NSCLC: FLEX

Phase III studies ongoing:Phase III studies ongoing:Adjuvant and Adjuvant and metastaticmetastatic CRCCRC

Esophageal cancerEsophageal cancer

Gastric cancerGastric cancer

Locally advanced NSCLCLocally advanced NSCLC

ErbituxErbitux –– Milestones in Further Milestones in Further Development Development


Data presented from 11 abstractsData presented from 11 abstractsChronic Chronic MyelogenousMyelogenous Leukemia (CML) Leukemia (CML) 22ndnd--line indicationline indication−− LongLong--term duration of response and survival in chronic term duration of response and survival in chronic

phase CML: 80% progressionphase CML: 80% progression--free survival at 2 yrsfree survival at 2 yrs−− Efficacy of 100mg onceEfficacy of 100mg once--daily SPRYCEL dose in patients daily SPRYCEL dose in patients

with baseline BCRwith baseline BCR--ABL mutations ABL mutations

Expanding into 1Expanding into 1stst--line CMLline CML−− Updated results of Phase I/II study of SPRYCEL in patients Updated results of Phase I/II study of SPRYCEL in patients

with previously untreated CML with previously untreated CML

First data in Solid Tumors First data in Solid Tumors

–– Phase II study of SPRYCEL in patients with castrationPhase II study of SPRYCEL in patients with castration--resistant (hormoneresistant (hormone--refractory) prostate cancerrefractory) prostate cancer

ASCO Highlights ASCO Highlights –– SPRYCELSPRYCEL


SPRYCEL SPRYCEL –– Expanding into 1Expanding into 1stst--line CMLline CMLHistorical 12Historical 12--month complete month complete cytogeneticcytogenetic responses responses ((CCyRCCyR) rate with ) rate with imatinibimatinib ~65%~65%

Rapid Rapid CCyRCCyR with SPRYCEL in this Phase I/II study in with SPRYCEL in this Phase I/II study in patients with previously untreated CML are highly patients with previously untreated CML are highly encouraging encouraging

–– 40 patients randomized to SPRYCEL either 50mg BID or 40 patients randomized to SPRYCEL either 50mg BID or 100mg QD100mg QD

–– 26 of 26 (100%) 26 of 26 (100%) evaluableevaluable patients achieved a patients achieved a CCyRCCyR byby12 months12 months

–– 30 of 32 (94%) 30 of 32 (94%) evaluableevaluable patients achieved a patients achieved a CCyRCCyR byby6 months6 months

Strong rationale for Phase III study in 1Strong rationale for Phase III study in 1stst--line CML, line CML, which is ongoing and recruiting rapidlywhich is ongoing and recruiting rapidly

Study SWOG–040, Cortes, et. al., ASCO, 2008


SPRYCEL SPRYCEL –– First Data in Solid Tumors: First Data in Solid Tumors: Study CharacteristicsStudy Characteristics

Phase II study of SPRYCEL in patients with castrationPhase II study of SPRYCEL in patients with castration--resistant resistant (hormone(hormone--refractory) prostate cancerrefractory) prostate cancer

Progressive disease based on rising PSAProgressive disease based on rising PSA

Castrate levels of testosterone (<50ng/dL)Castrate levels of testosterone (<50ng/dL)

No prior chemotherapyNo prior chemotherapy

Composite primary endpointComposite primary endpoint–– PSA responsePSA response–– bone scan responsebone scan response–– disease control according to RECIST criteriadisease control according to RECIST criteria

Assessment of urinary NAssessment of urinary N--telopeptidetelopeptide ((UNTxUNTx) as a marker of ) as a marker of bone metabolismbone metabolism

47 patients treated on 2 SPRYCEL BID regimens47 patients treated on 2 SPRYCEL BID regimens


Encouraging evidence of SPRYCEL efficacy in patients with Encouraging evidence of SPRYCEL efficacy in patients with metastaticmetastaticprostate cancerprostate cancerPSA:PSA:

–– 33 of 43 (77%) had an improved PSA doubling time33 of 43 (77%) had an improved PSA doubling time–– 18 of 43 (42%) had a decrease PSA velocity18 of 43 (42%) had a decrease PSA velocity–– 1 patient had a confirmed PSA response1 patient had a confirmed PSA response

Bone scan: Bone scan: –– 22 of 36 (61%) patients had stable or improved disease at 12 wee22 of 36 (61%) patients had stable or improved disease at 12 weeksks

Disease control: Disease control: –– 12 of 24 (50%) RECIST12 of 24 (50%) RECIST--evaluableevaluable patients had stable disease patients had stable disease

Bone Metabolism: Bone Metabolism: –– 32 of 39 (82%) with 32 of 39 (82%) with evaluableevaluable UNTxUNTx levels had a decrease from levels had a decrease from

baselinebaselineStudy is continuing with a QD regimenStudy is continuing with a QD regimenRationale for Rationale for

–– moving SPRYCEL into Phase III in prostate cancer moving SPRYCEL into Phase III in prostate cancer –– development of SPRYCEL in a variety of other solid tumorsdevelopment of SPRYCEL in a variety of other solid tumors

SPRYCEL SPRYCEL –– First Data in Solid TumorsFirst Data in Solid Tumors

Study -085, Yu, et. al., ASCO, 2008


SPRYCEL SPRYCEL –– Ongoing DevelopmentOngoing DevelopmentUpcoming regulatory filing:Upcoming regulatory filing:

22--year CML/year CML/Ph+ALLPh+ALL data for full approval of SPRYCELdata for full approval of SPRYCELOngoing development programs:Ongoing development programs:

FirstFirst--line CML in Phase IIIline CML in Phase IIISolid tumors includingSolid tumors including

–– Prostate cancer, transitioning to Phase IIIProstate cancer, transitioning to Phase III–– Breast cancerBreast cancer–– GlioblastomaGlioblastoma–– CRCCRC

HematologicHematologic malignancies includingmalignancies including–– Multiple Multiple myelomamyeloma–– Chronic Chronic lymphocyticlymphocytic leukemialeukemia

Additional data presentations:Additional data presentations:European Hematology Association (EHA), June 12European Hematology Association (EHA), June 12--16, 18 abstracts16, 18 abstracts


Data presented from 19 abstractsData presented from 19 abstracts

Advanced Malignant MelanomaAdvanced Malignant Melanoma . . . . . . .. . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . 15 15

Metastatic HormoneMetastatic Hormone--refractory Prostate Cancerrefractory Prostate Cancer . . . .. . . . 22

PrePre--clinicalclinical . . . . . . . .. . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . 1 1

Outcome Research/Health EconomicsOutcome Research/Health Economics . .. . . . . . . . . . . . . . .. . . . . . . . . . . . . 11

ASCO 2008 Highlights ASCO 2008 Highlights –– IpilimumabIpilimumab


Oral PresentationsOral Presentations

Advanced Malignant Melanoma: Advanced Malignant Melanoma: Ipilimumab showed Ipilimumab showed efficacy, with encouraging median overall survivalefficacy, with encouraging median overall survival

Novel efficacy findings for immunotherapy development: Novel efficacy findings for immunotherapy development: Immune activation precedes Immune activation precedes tumortumor shrinkage by weeksshrinkage by weeksto months to months

Prostate Cancer: Ipilimumab was generally well tolerated Prostate Cancer: Ipilimumab was generally well tolerated at the maximum dose tested in this study (10 mg/kg)at the maximum dose tested in this study (10 mg/kg)+/+/-- additional XRT in patients with hormoneadditional XRT in patients with hormone--refractory refractory prostate cancerprostate cancer

–– Seven confirmed responses (19%) and one Seven confirmed responses (19%) and one unconfirmed response (2.7%) as assessed by PSAunconfirmed response (2.7%) as assessed by PSA

ASCO 2008 Highlights ASCO 2008 Highlights –– IpilimumabIpilimumab


IpilimumabIpilimumab –– Phase II Advanced Melanoma Phase II Advanced Melanoma Program: Study CharacteristicsProgram: Study CharacteristicsStudy 8: N = 155Study 8: N = 155

SingleSingle--arm; 10 mg/kg arm; 10 mg/kg Progression on or after previously approved or Progression on or after previously approved or frequently used therapyfrequently used therapy

Study 22: N = 217Study 22: N = 21733--arm: 10 mg/kg, 3 mg/kg, and 0.3 mg/kgarm: 10 mg/kg, 3 mg/kg, and 0.3 mg/kgProgression or intolerance to any prior therapyProgression or intolerance to any prior therapy

Study 7: N = 115Study 7: N = 11522--arm: 10 mg/kg + placebo vs 10 mg/kg + prophylactic arm: 10 mg/kg + placebo vs 10 mg/kg + prophylactic budesonide budesonide Untreated or progression on or after any prior therapy Untreated or progression on or after any prior therapy


IpilimumabIpilimumab –– Best Objective Response Rate Best Objective Response Rate (BORR) (mWHO)(BORR) (mWHO)

Study 8Study 8(N = 155)(N = 155)

Study 22Study 22(N = 217)(N = 217)

Study 7Study 7(N = 115)(N = 115)

Dose scheduleDose schedule 3 mg/kg3 mg/kg 0.3mg/kg0.3mg/kg10 mg/kg 10 mg/kg

++budesonidebudesonide

BORR BORR (CR + PR), % (CR + PR), % (range)(range)

5.85.8(2.7(2.7--10.7)10.7)

1111(4.9(4.9--20.7)20.7)

4.24.2(0.9(0.9--11.7)11.7)

0 0 (0)(0)

15.815.8(7.5(7.5--27.9)27.9)

12.112.1(5(5--23.3)23.3)

DiseaseDiseasecontrol rate, %control rate, %

10 mg/kg10 mg/kg 10 mg/kg10 mg/kg10mg/kg + 10mg/kg +

placeboplacebo

27.127.1 29.229.2 35.135.126.426.4 13.713.7 31.031.0

BORR, best objective response rate; CR, complete response; PR, partial response;

mWHO, manual analysis on World Health Organization guidelines

Study -007, Weber, et. al., ASCO, 2008Study -008, O’Day, et. al., ASCO, 2008Study -022, Wolchock, et. al., ASCO, 2008


IpilimumabIpilimumab –– Median Overall Survival inMedian Overall Survival in3 Phase II Studies3 Phase II Studies

Study 8Study 8 Study 22Study 22 Study 7Study 7

10 mg/kg10 mg/kg(n = 155)(n = 155)

10 mg/kg10 mg/kg(n = 72)(n = 72)

3 mg/kg3 mg/kg(n = 72)(n = 72)

0.3 mg/kg0.3 mg/kg(n = 73)(n = 73)

10 mg/kg + 10 mg/kg + placeboplacebo(n = 57)(n = 57)

10 mg/kg + 10 mg/kg + budesonidebudesonide

(n = 58)(n = 58)

Median OSMedian OS, , mosmos (95% CI)(95% CI)

10.210.2(7.3, (7.3, ––))

14.614.6(6.9, (6.9, ––))

8.68.6(6.9, 12.3)(6.9, 12.3)

8.68.6(7.7, 14.5)(7.7, 14.5)

––(11.5, (11.5, ––))

––(6.8,(6.8, ––))

11--year OS, %year OS, %(95% CI)(95% CI)

4747(38.6, 55.6)(38.6, 55.6)

53.453.4(41.2, 63.7)(41.2, 63.7)

38.238.2(6.9, 12.3)(6.9, 12.3)

40.440.4(27.1, 53.8)(27.1, 53.8)

59.159.1(45.4, 72.2)(45.4, 72.2)

58.858.8(43.6, 70.3)(43.6, 70.3)

Median F/U,Median F/U,mosmos (range)(range)

9.59.5(3.6(3.6--12.3)12.3)

8.98.9(0.4(0.4--15.9)15.9)

8.18.1(0.4(0.4--17.0)17.0)

7.97.9(0.5(0.5--19.9)19.9)

10.910.9(0.3(0.3--20.1)20.1)

10.610.6(0.6(0.6--22.3)22.3)

Crossover toCrossover to10 mg/kg @ 10 mg/kg @

~12 wks~12 wks, n (%), n (%)~~ 1717

(24%)(24%)2525

(35%)(35%)2323

(32%)(32%) ~~ ~~

Updated Analysis (All Randomized)Updated Analysis (All Randomized)

Study -007, Weber, et. al., ASCO, 2008Study -008, O’Day, et. al., ASCO, 2008Study -022, Wolchock, et. al., ASCO, 2008


IpilimumabIpilimumab –– KaplanKaplan--Meier Estimate for Meier Estimate for Overall Survival per Dosing ScheduleOverall Survival per Dosing Schedule

10 mg/kg cohortMedian OS = 14.59 months53.39% 1-year survival

Prop

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0.3 mg/kg 0.3 mg/kg

3.0 mg/kg 3.0 mg/kg

10 mg/kg 10 mg/kg

CensoredCensored

CensoredCensored

CensoredCensored

Study -022, Wolchok, et. al., ASCO, 2008


IpilimumabIpilimumab –– Four Patterns of Response Four Patterns of Response Were ObservedWere Observed

Response in baseline lesions Response in baseline lesions

Stable disease with slow, steady decline in Stable disease with slow, steady decline in total tumor burden total tumor burden

Response after initial increase in total tumor Response after initial increase in total tumor burden burden

Response in total tumor burden in the Response in total tumor burden in the presence of new lesions presence of new lesions


IpilimumabIpilimumab –– ImmuneImmune--related Adverse Eventsrelated Adverse EventsSafety populationSafety population

10 mg/kg10 mg/kg(n=71)(n=71)

3 mg/kg3 mg/kg(n=71)(n=71)

SevereSevere(grade 3(grade 3--4)4)

25.425.415.515.5

2.82.81.41.44.24.2

00 00

00 1.41.4**


7.07.02.82.8

002.82.81.41.4


0000000000

0.3 mg/kg0.3 mg/kg(n=72)(n=72)

Any Any –– %%GI GI –– %%Hepatobiliary Hepatobiliary –– %%Endocrine Endocrine –– %%Skin Skin –– %%

Bowel perforations Bowel perforations –– %% 00

DrugDrug--related deaths related deaths –– %% 00** Death caused by grade 3 respiratory infection possibly related tDeath caused by grade 3 respiratory infection possibly related to treatment.o treatment.

Patient was a tobacco user with lung metastasesPatient was a tobacco user with lung metastases

Study -022, Wolchok, et. al., ASCO, 2008


IpilimumabIpilimumab –– Summary: MelanomaSummary: MelanomaSurvival rates across the Phase II program were encouragingSurvival rates across the Phase II program were encouragingand consistentand consistent

–– Median range 10Median range 10--15 months15 months–– ~50% alive at 1 year~50% alive at 1 year

Early biological activity, but variable timeframe to evolve a Early biological activity, but variable timeframe to evolve a measurable clinical effectmeasurable clinical effect

Four patterns of response observed likely contributed to the Four patterns of response observed likely contributed to the observed OS rates, despite modest BORR per mWHOobserved OS rates, despite modest BORR per mWHO

ImmuneImmune--related AEs were manageable and reversible with prompt related AEs were manageable and reversible with prompt treatment using established guidelines or treatment withdrawaltreatment using established guidelines or treatment withdrawal

Conducting ongoing studies focused on overall survival to betterConducting ongoing studies focused on overall survival to betterquantify the benefit/risk profile for the compoundquantify the benefit/risk profile for the compound


IpilimumabIpilimumab –– Ongoing DevelopmentOngoing DevelopmentMonotherapyMonotherapy

–– Adjuvant melanoma trial to be initiated shortlyAdjuvant melanoma trial to be initiated shortly

Combination with ChemotherapyCombination with Chemotherapy–– Phase II program in combination with Phase II program in combination with carbo/taxolcarbo/taxol

in lung cancer (SCLC and NSCLC)in lung cancer (SCLC and NSCLC)

Combination with RadiationCombination with Radiation–– Phase II study ongoing in prostate cancerPhase II study ongoing in prostate cancer

Other combinations under explorationOther combinations under exploration–– Combination with GVAXCombination with GVAX–– Combination with targeted therapiesCombination with targeted therapies


ASCO 2008 Highlights ASCO 2008 Highlights –– Summary Summary ErbituxErbitux®®

–– FLEX data showing improved overall survival in FLEX data showing improved overall survival in NSCLC NSCLC

–– CRYSTAL KRAS analysis showing additional PFS CRYSTAL KRAS analysis showing additional PFS benefit in CRC patients with wildbenefit in CRC patients with wild--type KRAStype KRAS

SPRYCELSPRYCEL®®

–– Data showing efficacy in firstData showing efficacy in first--line CMLline CML–– First solid tumor data in prostate cancer First solid tumor data in prostate cancer

supporting Phase III transitionsupporting Phase III transition

IpilimumabIpilimumab–– New data showing encouraging overall survivalNew data showing encouraging overall survival

in advanced melanomain advanced melanoma


ASCO 2008 Highlights*ASCO 2008 Highlights*



*American Society of Clinical Oncology, May 30 – June 3, 2008*American Society of Clinical Oncology, May 30 – June 3, 2008

Economy & Finance

bristol myerd squibb American Society of Clinical Oncology (ASCO) Highlights